Qureos Mentor

Amerikan Hastanesi

<div>
 
 Stembio (
 
 Ko&ccedil; Holding/Ko&ccedil; Healthcare
 
 i&scedil;tiraki),
 
 Mezenkimal K&ouml;k H&uuml;creler (MSC), Eksozomlar, &Idot;mm&uuml;noterapi &Uuml;r&uuml;nleri, Kordon Kan&inodot; Bankalama ve Doku Greftleri
 
 &uuml;retimi ve haz&inodot;rlanmas&inodot; konusunda uzmanla&scedil;m&inodot;&scedil;, ileri teknolojiye sahip bir
 
 cGMP laboratuvar&inodot;d&inodot;r
 
 . Kalite kontrol ve validasyon s&uuml;re&ccedil;lerine b&uuml;y&uuml;k &ouml;nem vererek,
 
 y&uuml;ksek kaliteli ve reg&uuml;lasyonlara uygun
 
 h&uuml;cresel tedavi &uuml;r&uuml;nleri sunmay&inodot; taahh&uuml;t ediyoruz.
 
 
 
 
 
 
 Stembio
 
 'da g&ouml;revlendirilmek &uuml;zere
 
 &Idot;nsan Kaynaklar&inodot; Uzman&inodot;
 
 aray&inodot;&scedil;&inodot;m&inodot;z bulunmaktad&inodot;r.
 
 
 
 
 
 
 Genel Nitelikler
 
 
 
 
 
 <ul>
 <li>
 &Uuml;niversitelerin &Idot;&scedil;letme, Ekonomi, &Ccedil;al&inodot;&scedil;ma Ekonomisi ve End&uuml;stri &Idot;li&scedil;kileri veya ilgili b&ouml;l&uuml;mlerinden mezun
 </li>
 <li>
 Tercihen en az 2 y&inodot;l insan kaynaklar&inodot; i&scedil;e al&inodot;m, e&gbreve;itim, performans y&ouml;netimi, organizasyonel geli&scedil;im, &ccedil;al&inodot;&scedil;an deneyimi, &uuml;cretlendirme ve yan haklar fonksiyonlar&inodot;nda deneyimli
 </li>
 <li>
 Tercihen Oracle HR mod&uuml;l&uuml; bilgisi olan
 </li>
 <li>
 MS Office (Word, Excel, Powerpoint) programlar&inodot; konusunda yetkin
 </li>
 <li>
 &Idot;leri seviyede yaz&inodot;l&inodot; ve s&ouml;zl&uuml; &Idot;ngilizce bilgisine sahip
 </li>
 <li>
 &Idot;leti&scedil;imi g&uuml;&ccedil;l&uuml;, sorumluluk almay&inodot; yeni projeler &uuml;retmeyi seven, koordinasyon ve i&scedil;birli&gbreve;i ile &ccedil;al&inodot;&scedil;ma konusunda yetkin, ara&scedil;t&inodot;rma, geli&scedil;tirme ve analiz yetene&gbreve;i kuvvetli
 </li>
 </ul>
 
 
 
 
 
 Rol ve Sorumluluklar
 
 
 
 
 
 <ul>
 <li>
 &Idot;nsan Kaynaklar&inodot; stratejisinin ve s&uuml;re&ccedil;lerinin (se&ccedil;me yerle&scedil;tirme, kariyer ve yetenek y&ouml;netimi, e&gbreve;itim ve geli&scedil;im, &ccedil;al&inodot;&scedil;an ba&gbreve;l&inodot;l&inodot;&gbreve;&inodot;, performans y&ouml;netimi, &ccedil;al&inodot;&scedil;an deneyimi) uygulanmas&inodot;na y&ouml;nelik mevcut ihtiya&ccedil;lar&inodot;n&inodot; belirlemek, bu ihtiya&ccedil;lar do&gbreve;rultusunda proje planlar&inodot;n&inodot; olu&scedil;turmak ve ilgili ekiplerle birlikte projeleri y&uuml;r&uuml;tmek
 </li>
 <li>
 Sorumlu oldu&gbreve;u fonksiyonlarda; y&inodot;ll&inodot;k i&scedil;g&uuml;c&uuml; plan&inodot; &ccedil;al&inodot;&scedil;malar&inodot;n&inodot; koordine ederek i&scedil;e al&inodot;m s&uuml;re&ccedil;lerini y&uuml;r&uuml;tmek, performans de&gbreve;erlendirme, yetenek y&ouml;netimi, &ouml;d&uuml;llendirme sistemi ve e&gbreve;itim ve geli&scedil;im gibi t&uuml;m &Idot;nsan Kaynaklar&inodot; s&uuml;re&ccedil;lerinin takip edilmesinden sorumlu olmak
 </li>
 <li>
 Topluluk genelinde insan kaynaklar&inodot; uygulamalar&inodot;n&inodot;n uyum i&ccedil;inde y&uuml;r&uuml;t&uuml;lmesi ve geli&scedil;tirilmesine y&ouml;nelik proje tak&inodot;mlar&inodot;n&inodot; olu&scedil;turmak ve liderlik etmek
 </li>
 <li>
 Aday ve &ccedil;al&inodot;&scedil;an deneyiminin m&uuml;kemmelle&scedil;tirilmesi i&ccedil;in iyile&scedil;tirilmesi gereken noktalar&inodot; tespit etmek, &Idot;K stratejisi ve ihtiya&ccedil;lar&inodot; do&gbreve;rultusunda projelerin y&uuml;r&uuml;t&uuml;lmesini sa&gbreve;lamak
 </li>
 <li>
 &Idot;nsan kaynaklar&inodot; uygulamalar&inodot;n&inodot; ara&scedil;t&inodot;rmak, uygulanabilecek yeni &ouml;nerileri geli&scedil;tirmek, bu hedeflere ula&scedil;mak i&ccedil;in uygun platformlar&inodot;n kullan&inodot;lmas&inodot;n&inodot; sa&gbreve;lamak
 </li>
 <li>
 &Ccedil;al&inodot;&scedil;an ba&gbreve;l&inodot;l&inodot;&gbreve;&inodot;n&inodot; artt&inodot;rmaya ve i&scedil;veren markas&inodot;n&inodot; g&uuml;&ccedil;lendirmeye y&ouml;nelik projeler geli&scedil;tirmek
 </li>
 <li>
 &Ccedil;al&inodot;&scedil;anlar&inodot;n talep etti&gbreve;i resmi yaz&inodot;lar&inodot;n haz&inodot;rlanmas&inodot; ve &ccedil;al&inodot;&scedil;anlara sorunsuz bir &scedil;ekilde iletilmesini sa&gbreve;lamak,
 </li>
 <li>
 &Idot;&scedil;e Giri&scedil; evrak s&uuml;re&ccedil;lerinde adaylar&inodot;n belge kontrol&uuml;n&uuml;n yap&inodot;lmas&inodot; ve gerekli organizasyonun yap&inodot;lmas&inodot;,
 </li>
 <li>
 Resmi kurum ve kurulu&scedil;larla (Sa&gbreve;l&inodot;k Bakanl&inodot;&gbreve;&inodot;, &Idot;&scedil;kur ve Emniyet Bildirimi) ile ilgili yasal s&uuml;re&ccedil;leri sorunsuz olarak y&uuml;r&uuml;tmek ve gerekli yaz&inodot;&scedil;malar&inodot; yapmak,
 </li>
 <li>
 Personel i&scedil;e giri&scedil; ve i&scedil;ten &ccedil;&inodot;k&inodot;&scedil; i&scedil;lemlerinin yasal mevzuata uygun bir &scedil;ekilde y&uuml;r&uuml;t&uuml;lmesi
 </li>
 <li>
 &Idot;&scedil;ten ayr&inodot;lan personelin k&inodot;dem, ihbar tazminatlar&inodot;n&inodot; ve di&gbreve;er hak edi&scedil;lerinin hesaplanmas&inodot;
 </li>
 <li>
 &Uuml;cret similasyonlar&inodot;n&inodot;n ve teklif mektuplar&inodot;n&inodot;n &ccedil;al&inodot;&scedil;&inodot;lmas&inodot;
 </li>
 <li>
 &Idot;&scedil; g&ouml;rmezlik raporlar&inodot;n&inodot;n takip edilmesi
 </li>
 <li>
 SGK, &Idot;&scedil;kur ve di&gbreve;er resmi kurumlara yap&inodot;lmas&inodot; gereken t&uuml;m yasal bildirimlerin yasal s&uuml;reler i&ccedil;erisinde yap&inodot;lmas&inodot;
 </li>
 <li>
 Puantaj kontrol ve aktar&inodot;mlar&inodot;n&inodot;n yap&inodot;lma s&uuml;recinin y&uuml;r&uuml;tmesi
 </li>
 </ul>
 
 
 
 
 
 Ki&scedil;isel verileriniz, i&scedil; ba&scedil;vurunuzun al&inodot;nmas&inodot; ve de&gbreve;erlendirmesi amac&inodot;yla i&scedil;lenmektedir. &Idot;&scedil;lenen ki&scedil;isel verilerinize ve haklar&inodot;n&inodot;za ili&scedil;kin detayl&inodot; bilgilere websitemizin &ldquo;&Idot;nsan Kaynaklar&inodot;&rdquo; ba&scedil;l&inodot;&gbreve;&inodot; i&ccedil;erisinde yer alan&ldquo;&Ccedil;al&inodot;&scedil;an Aday&inodot; Ayd&inodot;nlatma Metni&rsquo;nden ula&scedil;abilirsiniz.
 
 
</div>

Stembio - İnsan Kaynakları Uzmanı

<div>
 
 Stembio (
 
 Ko&ccedil; Holding/Ko&ccedil; Healthcare
 
 i&scedil;tiraki),
 
 Mezenkimal K&ouml;k H&uuml;creler (MSC), Eksozomlar, &Idot;mm&uuml;noterapi &Uuml;r&uuml;nleri, Kordon Kan&inodot; Bankalama ve Doku Greftleri
 
 &uuml;retimi ve haz&inodot;rlanmas&inodot; konusunda uzmanla&scedil;m&inodot;&scedil;, ileri teknolojiye sahip bir
 
 cGMP laboratuvar&inodot;d&inodot;r
 
 . Kalite kontrol ve validasyon s&uuml;re&ccedil;lerine b&uuml;y&uuml;k &ouml;nem vererek,
 
 y&uuml;ksek kaliteli ve reg&uuml;lasyonlara uygun
 
 h&uuml;cresel tedavi &uuml;r&uuml;nleri sunmay&inodot; taahh&uuml;t ediyoruz.
 
 
 
 
 
 Yenilik&ccedil;i &uuml;r&uuml;n portf&ouml;y&uuml;m&uuml;zde &mdash; ATMP&rsquo;ler, t&inodot;bbi cihazlar ve kozmetik s&inodot;n&inodot;f biyolojik &uuml;r&uuml;nler dahil &mdash; reg&uuml;lasyon stratejilerini y&uuml;r&uuml;tecek ve destekleyecek, erken geli&scedil;tirme a&scedil;amas&inodot;ndan klinik &ccedil;al&inodot;&scedil;ma izinlerine ve &uuml;r&uuml;n ticarile&scedil;tirmeye kadar t&uuml;m s&uuml;re&ccedil;lerde T&Idot;TCK, ard&inodot;ndan EMA (Avrupa) ve FDA (ABD) &ccedil;er&ccedil;evelerine uygun reg&uuml;lasyon uyumlulu&gbreve;unu sa&gbreve;lamaktan sorumlu
 
 Stembio
 
 'da g&ouml;revlendirilmek &uuml;zere bir
 
 Reg&uuml;lasyon Uzman&inodot;
 
 aray&inodot;&scedil;&inodot;nday&inodot;z.
 
 
 
 
 
 E&gbreve;er Ar-Ge, Kalite ve &Uuml;retim ekipleriyle yak&inodot;n i&scedil; birli&gbreve;i i&ccedil;inde &ccedil;al&inodot;&scedil;arak Stembio &uuml;r&uuml;nlerinin uluslararas&inodot; standartlara uygun ve hem yerel hem k&uuml;resel pazarlara haz&inodot;r hale getirilmesi konusunda yetkin oldu&gbreve;unuzu d&uuml;&scedil;&uuml;n&uuml;yorsan&inodot;z, ba&scedil;vurunuzu bekliyoruz!
 
 
 
 
 
 
 Genel Nitelikler
 
 
 
 
 
 <ul>
 <li>
 Biyolojik Bilimler, Biyoteknoloji, Eczac&inodot;l&inodot;k, Biyomedikal M&uuml;hendisli&gbreve;i, Kimya veya ilgili bir alanda lisans veya &uuml;zeri derece.
 </li>
 <li>
 Tercihen biyoteknoloji, ila&ccedil; veya t&inodot;bbi cihaz sekt&ouml;rlerinde en az 5 y&inodot;l Reg&uuml;lasyon alan&inodot;nda deneyim.
 </li>
 <li>
 ATMP, GMP, CE i&scedil;areti, MDR/IVDR ve klinik &ccedil;al&inodot;&scedil;ma d&uuml;zenlemeleri hakk&inodot;nda sa&gbreve;lam bilgi.
 </li>
 <li>
 K&uuml;resel reg&uuml;lasyon &ccedil;er&ccedil;evelerine h&acirc;kimiyet:
 </li>
 </ul>
 
 
 
 
 
 T&uuml;rkiye:
 
 T&Idot;TCK (ATMP ve cihaz kay&inodot;tlar&inodot;, klinik &ccedil;al&inodot;&scedil;ma izinleri
 
 
 
 Avrupa:
 
 EMA (CAT, EudraCT, EudraVigilance)
 
 
 
 K&uuml;resel:
 
 FDA (CBER), ICH k&inodot;lavuzlar&inodot;, ISO standartlar&inodot;
 
 
 
 
 <ul>
 <li>
 &Uuml;r&uuml;n kay&inodot;t dosyalar&inodot;, teknik belgeler ve klinik dok&uuml;mantasyon haz&inodot;rlama deneyimi.
 </li>
 <li>
 T&uuml;rk&ccedil;e ve &Idot;ngilizce yaz&inodot;l&inodot;/s&ouml;zl&uuml; ileti&scedil;im becerileri g&uuml;&ccedil;l&uuml;.
 </li>
 <li>
 &Ccedil;ok disiplinli ekiplerle &ccedil;al&inodot;&scedil;abilen, &ouml;ncelik y&ouml;netimi kuvvetli, dinamik ortamlarda etkin &ccedil;al&inodot;&scedil;abilen.
 </li>
 <li>
 Etik de&gbreve;erlere sahip, d&uuml;zenli, detaylara &ouml;nem veren ve reg&uuml;lasyon bilimi ile yenili&gbreve;e tutkulu.
 </li>
 </ul>
 
 
 
 
 
 Rol ve Sorumluluklar
 
 
 
 
 
 
 
 Reg&uuml;lasyon Stratejisi ve &Uuml;r&uuml;n Geli&scedil;tirme
 
 
 
 
 
 <ul>
 <li>
 Stembio&rsquo;nun &uuml;r&uuml;n portf&ouml;y&uuml; i&ccedil;in reg&uuml;lasyon stratejilerini geli&scedil;tirmek ve uygulamak.
 </li>
 <li>
 Klinik &ccedil;al&inodot;&scedil;ma onaylar&inodot;, GMP sertifikasyonlar&inodot; ve ruhsat ba&scedil;vurular&inodot;n&inodot; (T&Idot;TCK, EMA, FDA) planlamak ve y&ouml;netmek.
 </li>
 <li>
 Ba&scedil;vuru ve onay takvimlerini belirleyerek, i&ccedil; ekiplerle koordinasyon i&ccedil;inde hedeflenen lansman tarihlerine ula&scedil;&inodot;lmas&inodot;n&inodot; sa&gbreve;lamak.
 </li>
 <li>
 K&uuml;resel &uuml;r&uuml;n dosyalar&inodot;n&inodot; yerel reg&uuml;lasyon formatlar&inodot;na uyarlamak ve gerekli ek dok&uuml;mantasyonu haz&inodot;rlamak.
 </li>
 <li>
 Yeni endikasyonlar, teknoloji transferleri ve i&scedil; birlikleri i&ccedil;in reg&uuml;lasyon due diligence &ccedil;al&inodot;&scedil;malar&inodot;na destek vermek.
 </li>
 </ul>
 
 
 
 
 
 Reg&uuml;lasyon Uyumu ve Kurumsal &Idot;leti&scedil;im
 
 
 
 
 
 <ul>
 <li>
 T&uuml;rkiye, Avrupa Birli&gbreve;i ve ABD&rsquo;deki ATMP, t&inodot;bbi cihaz ve kozmetik mevzuatlar&inodot;ndaki geli&scedil;meleri takip etmek ve yorumlamak.
 </li>
 <li>
 Reg&uuml;lasyon kurumlar&inodot;yla (T&Idot;TCK, EMA, FDA, Onaylanm&inodot;&scedil; Kurulu&scedil;lar) aktif ileti&scedil;im y&uuml;r&uuml;tmek, denetimlerde ve incelemelerde Stembio&rsquo;yu temsil etmek.
 </li>
 <li>
 GMP ve reg&uuml;lasyon denetimlerine y&ouml;nelik haz&inodot;r olma durumunu sa&gbreve;lamak, denetim cevaplar&inodot;n&inodot; ve CAPA s&uuml;re&ccedil;lerini y&ouml;netmek.
 </li>
 <li>
 T&uuml;rkiye ve AB&rsquo;de ATMP alan&inodot;ndaki reg&uuml;lasyon &ccedil;er&ccedil;evesini &scedil;ekillendiren sekt&ouml;r giri&scedil;imlerinde aktif rol almak.
 </li>
 </ul>
 
 
 
 
 
 Standartlar, Sertifikasyon ve Dok&uuml;mantasyon
 
 
 
 
 
 <ul>
 <li>
 Ge&ccedil;erli uluslararas&inodot; standartlara (ISO 13485, ISO 10993, EN, IEC, ICH Q serisi) ve y&ouml;netmeliklere (CE i&scedil;areti, MDSAP, MDR, IVDR) uygunlu&gbreve;u sa&gbreve;lamak.
 </li>
 <li>
 &Uuml;r&uuml;n kay&inodot;t dosyalar&inodot;, teknik dok&uuml;mantasyon, etiketleme ve kullan&inodot;m k&inodot;lavuzlar&inodot;n&inodot; haz&inodot;rlamak, g&ouml;zden ge&ccedil;irmek ve g&uuml;ncel tutmak.
 </li>
 <li>
 Sertifikasyon s&uuml;re&ccedil;lerini (&ouml;r. CE, TSE, Eurovent, PED) koordine etmek; akredite test laboratuvarlar&inodot; ve sertifikasyon kurulu&scedil;lar&inodot;yla ileti&scedil;imi y&uuml;r&uuml;tmek.
 </li>
 </ul>
 
 
 
 
 
 Klinik &Ccedil;al&inodot;&scedil;malar ve Pazar Sonras&inodot; Faaliyetler
 
 
 
 
 
 <ul>
 <li>
 Klinik &ccedil;al&inodot;&scedil;ma ba&scedil;vurular&inodot;, tadilatlar&inodot; ve yenilemelerini T&Idot;TCK ve EMA &ccedil;er&ccedil;evelerinde desteklemek.
 </li>
 <li>
 ATMP&rsquo;lere y&ouml;nelik k&uuml;resel klinik ara&scedil;t&inodot;rma ortam&inodot;n&inodot; takip etmek ve Klinik &Ccedil;al&inodot;&scedil;ma Yetkilendirmesi (CTA) dosyalar&inodot;n&inodot;n haz&inodot;rlanmas&inodot;na katk&inodot; sa&gbreve;lamak.
 </li>
 <li>
 Onayl&inodot; &uuml;r&uuml;nler i&ccedil;in pazar sonras&inodot; g&ouml;zetim, g&uuml;venlilik raporlamas&inodot; ve s&uuml;rekli emniyet g&uuml;ncellemelerini y&uuml;r&uuml;tmek.
 </li>
 </ul>
 
 
 
 
 
 &Idot;&ccedil; Kalite ve S&uuml;re&ccedil; Entegrasyonu
 
 
 
 
 
 <ul>
 <li>
 Reg&uuml;lasyon ve GMP standartlar&inodot;na uygunlu&gbreve;u sa&gbreve;lamak &uuml;zere i&ccedil; denetimler ger&ccedil;ekle&scedil;tirmek.
 </li>
 <li>
 Kalite G&uuml;vence, Ar-Ge, &Uuml;retim ve Hukuk ekipleriyle i&scedil; birli&gbreve;i i&ccedil;inde &uuml;r&uuml;n ya&scedil;am d&ouml;ng&uuml;s&uuml;n&uuml;n her a&scedil;amas&inodot;nda reg&uuml;lasyon entegrasyonunu sa&gbreve;lamak.
 </li>
 <li>
 Uyumsuzluk risklerini tespit etmek ve proaktif &ouml;nleme stratejileri geli&scedil;tirmek.
 </li>
 </ul>
 
 
 
 
 
 Ki&scedil;isel verileriniz, i&scedil; ba&scedil;vurunuzun al&inodot;nmas&inodot; ve de&gbreve;erlendirmesi amac&inodot;yla i&scedil;lenmektedir. &Idot;&scedil;lenen ki&scedil;isel verilerinize ve haklar&inodot;n&inodot;za ili&scedil;kin detayl&inodot; bilgilere websitemizin &ldquo;&Idot;nsan Kaynaklar&inodot;&rdquo; ba&scedil;l&inodot;&gbreve;&inodot; i&ccedil;erisinde yer alan&ldquo;&Ccedil;al&inodot;&scedil;an Aday&inodot; Ayd&inodot;nlatma Metni&rsquo;nden ula&scedil;abilirsiniz.
 
 
 
 
 
 
 -------------------------------------------------------------------------------------------------------------
 
 
 
 
 
 Stembio (a Koc Holding/Koc Healthcare company) is a cutting-edge cGMP laboratory specializing in the production and preparation of Mesenchymal Stem Cells (MSCs), Exosomes, Immunotherapy Products, Cord Blood Banking, and Tissue Grafts. We are committed to delivering high-quality, regulatory-compliant cell therapy products through rigorous quality control and validation processes.
 
 
 
 
 
 We are seeking for a qualified and experienced
 
 Regulatory Affairs Specialist
 
 
 for Stembio,
 
 who
 
 
 will be responsible for ensuring regulatory compliance from early development to clinical trial authorization and product commercialization, initially under Turkish Medicines and Medical Devices Agency (T&Idot;TCK), and subsequently through EMA (Europe) and FDA (U.S.) frameworks,
 
 
 to lead and support regulatory strategies across Stembio&rsquo;s innovative product lines &mdash; including ATMPs, medical devices, and cosmetic-grade biologics.
 
 
 
 
 
 If you are passionate about creating close collaboration with R&amp;D, Quality, and Production teams to ensure Stembio&rsquo;s products meet international standards and are launch-ready for both local and global markets, we encourage you to apply!
 
 
 
 
 
 
 Qualifications
 
 
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s or higher degree in Biological Sciences, Biotechnology, Pharmacy, Biomedical Engineering, Chemistry, or a related discipline.
 </li>
 <li>
 Minimum 5 years of experience in Regulatory Affairs, ideally within the biotechnology, pharmaceutical, or medical device sectors.
 </li>
 <li>
 Solid understanding of ATMP, GMP, CE marking, MDR/IVDR, and clinical trial regulations.
 </li>
 <li>
 Familiarity with global regulatory frameworks:
 </li>
 </ul>
 
 
 
 
 
 T&uuml;rkiye:
 
 T&Idot;TCK (ATMP and Device Registration, Clinical Trial Authorization)
 
 
 
 Europe:
 
 EMA (CAT, EudraCT, EudraVigilance)
 
 
 
 Global:
 
 FDA (CBER), ICH guidelines, ISO standards
 
 <ul>
 <li>
 Experience in preparing and maintaining product registration files, technical documentation, and clinical dossiers.
 </li>
 <li>
 Strong communication skills in Turkish and English (both written and spoken).
 </li>
 <li>
 Ability to work effectively in cross-functional teams and manage multiple priorities in a dynamic environment.
 </li>
 <li>
 Ethical, organized, and detail-oriented mindset with a passion for regulatory science and innovation.
 </li>
 </ul>
 
 
 
 
 
 Key Responsibilities
 
 
 
 
 
 
 
 Regulatory Strategy &amp; Product Development
 
 
 
 
 
 <ul>
 <li>
 Develop and execute regulatory strategies for Stembio&rsquo;s Product Pipeline.
 </li>
 <li>
 Plan and manage regulatory submissions for clinical trial approvals, GMP certifications, and marketing authorizations under T&Idot;TCK, EMA, and FDA.
 </li>
 <li>
 Define submission and approval timelines, coordinating with internal teams to meet launch targets.
 </li>
 <li>
 Adapt global product dossiers to local regulatory formats and gather supplementary documentation as needed.
 </li>
 <li>
 Support regulatory due diligence for new indications, technology transfers, and collaborations.
 </li>
 </ul>
 
 
 
 
 
 Regulatory Compliance &amp; Institutional Liaison
 
 
 
 
 
 <ul>
 <li>
 Monitor and interpret evolving legislation on ATMPs, medical devices, and cosmetics across T&uuml;rkiye, EU, and the U.S.
 </li>
 <li>
 Maintain active communication with regulatory bodies (T&Idot;TCK, EMA, FDA, Notified Bodies) and represent Stembio during inspections and audits.
 </li>
 <li>
 Ensure inspection-readiness for GMP and regulatory audits; manage audit responses and CAPAs.
 </li>
 <li>
 Engage with industry associations to support advocacy initiatives shaping the Turkish and EU ATMP landscape.
 </li>
 </ul>
 
 
 
 
 
 Standards, Certification &amp; Documentation
 
 
 
 
 
 <ul>
 <li>
 Ensure compliance with applicable international standards (ISO 13485, ISO 10993, EN, IEC, ICH Q-series) and directives (CE marking, MDSAP, MDR, IVDR).
 </li>
 <li>
 Prepare, review, and maintain technical documentation, including product registration files, device master records, labeling, and instructions for use.
 </li>
 <li>
 Coordinate certification processes (e.g., CE, TSE, Eurovent, PED) and liaise with accredited test laboratories and certification bodies.
 </li>
 </ul>
 
 
 
 
 
 Clinical Trials &amp; Post-Market Activities
 
 
 
 
 
 <ul>
 <li>
 Support clinical trial submissions, amendments, and renewals under T&Idot;TCK and EMA frameworks.
 </li>
 <li>
 Track the global clinical trial landscape for ATMPs and contribute to dossier compilation for Clinical Trial Authorization (CTA).
 </li>
 <li>
 Oversee post-market surveillance, vigilance reporting, and continuous safety updates for approved products.
 </li>
 </ul>
 
 
 
 
 
 Internal Quality &amp; Process Integration
 
 
 
 
 
 <ul>
 <li>
 Conduct internal audits to ensure adherence to regulatory and GMP standards.
 </li>
 <li>
 Collaborate with Quality Assurance, R&amp;D, Production, and Legal teams to ensure full regulatory integration across the product lifecycle.
 </li>
 <li>
 Identify compliance risks and develop proactive mitigation strategies.
 </li>
 </ul>
 
 
 
 
 
 Your personal data is processed for the purpose of receiving and evaluating your job application. You can find detailed information about your processed personal data and rights from the "Employee Candidate Clarification Text" under the "Human Resources" heading of our website.
 
 
</div>

Stembio - Regülasyon Uzmanı / Regulatory Affairs Specialist

<div>
 
 Stembio (a Koc Holding/Koc Healthcare company) is a cutting-edge cGMP laboratory specializing in the production and preparation of cellular products such as; Car-T/TILs, Mesenchymal Stem Cells (MSCs), exosomes, immunotherapy products, cord blood banking and tissue grafts. We are committed to delivering high-quality, regulatory-compliant cell therapy products through rigorous quality control and validation processes.
 
 
 
 
 
 We are seeking an experienced and strategic
 
 Head of Quality Control for Stembio
 
 to lead and oversee all quality control (QC) activities for our cell therapy products.
 
 
 
 
 
 This role is responsible for ensuring the accuracy, reliability, and compliance of QC testing, maintaining product integrity, and upholding regulatory and cGMP standards. The ideal candidate will have extensive experience in analytical testing, method validation, and laboratory operations, along with a proactive approach to continuous improvement and compliance.
 
 
 
 
 
 If you are passionate about quality control in advanced cell therapies and have the expertise to uphold the highest standards, we encourage you to apply!
 
 
 
 
 
 
 Qualifications
 
 
 
 
 
 <ul>
 <li>
 Advanced degree (PhD, or equivalent) in Biology, Biochemistry, Analytical Chemistry, or a related field.
 </li>
 <li>
 Minimum of 5 years of experience in Quality Control within preferably a GMP-regulated biopharmaceutical or cell therapy environment or Academia.
 </li>
 <li>
 Strong expertise in analytical techniques such as flow cytometry, PCR, ELISA, HPLC, and microbiological testing.
 </li>
 <li>
 Proven leadership experience, with the ability to manage and develop high-performing teams.
 </li>
 <li>
 Deep understanding of regulatory requirements (cGMP, TITCK, EMA, ICH) and industry best practices for QC.
 </li>
 <li>
 Excellent problem-solving skills, attention to detail, and a commitment to continuous improvement.
 </li>
 </ul>
 
 
 
 
 
 Key Responsibilities
 
 
 
 
 
 <ul>
 <li>
 Lead and manage the Quality Control department, ensuring all testing activities meet regulatory, company, and cGMP standards.
 </li>
 <li>
 Oversee analytical, microbiological, and raw material testing to ensure product safety, efficacy, and consistency.
 </li>
 <li>
 Drive method validation, transfer, and optimization to support robust and reliable analytical processes.
 </li>
 <li>
 Collaborate with manufacturing, quality assurance, and regulatory teams to maintain product quality throughout the lifecycle.
 </li>
 <li>
 Ensure compliance with CGMP, TITCK, EMA, and other regulatory requirements through rigorous documentation, data integrity, and audit readiness.
 </li>
 <li>
 Manage laboratory operations, including equipment qualification, personnel training, and process improvements.
 </li>
 <li>
 Implement and oversee stability studies, environmental monitoring, and trending analysis to detect and prevent potential quality issues.
 </li>
 <li>
 Lead investigations and corrective actions for out-of-specification (OOS) results, deviations, and other QC-related issues.
 </li>
 <li>
 Stay current with industry advancements and regulatory changes to ensure the QC function remains best-in-class.
 </li>
 </ul>
 
 
 
 
 
 Your personal data is processed for the purpose of receiving and evaluating your job application. You can find detailed information about your processed personal data and rights from the "Employee Candidate Clarification Text" under the "Human Resources" heading of our website.
 
 
 
 
</div>

Stembio - Head of Quality Control

<div>
 
 Stembio (
 
 Ko&ccedil; Holding/Ko&ccedil; Healthcare
 
 i&scedil;tiraki),
 
 Mezenkimal K&ouml;k H&uuml;creler (MSC), Eksozomlar, &Idot;mm&uuml;noterapi &Uuml;r&uuml;nleri, Kordon Kan&inodot; Bankalama ve Doku Greftleri
 
 &uuml;retimi ve haz&inodot;rlanmas&inodot; konusunda uzmanla&scedil;m&inodot;&scedil;, ileri teknolojiye sahip bir
 
 cGMP laboratuvar&inodot;d&inodot;r
 
 . Kalite kontrol ve validasyon s&uuml;re&ccedil;lerine b&uuml;y&uuml;k &ouml;nem vererek,
 
 y&uuml;ksek kaliteli ve reg&uuml;lasyonlara uygun
 
 h&uuml;cresel tedavi &uuml;r&uuml;nleri sunmay&inodot; taahh&uuml;t ediyoruz.
 
 
 
 
 
 Stembio olarak, h&uuml;cresel tedavi &uuml;r&uuml;nlerinde yenilik&ccedil;i &ccedil;&ouml;z&uuml;mler geli&scedil;tirmeyi ama&ccedil;layan ara&scedil;t&inodot;rma ve &uuml;retim faaliyetlerimize katk&inodot; sa&gbreve;layacak, bilimsel merak&inodot; y&uuml;ksek ve teknik becerileri g&uuml;&ccedil;l&uuml; bir
 
 Stembio
 
 'da g&ouml;revlendirilmek &uuml;zere
 
 &Uuml;r&uuml;n Geli&scedil;tirme Uzman&inodot; (&Uuml;R-GE Uzman&inodot;)
 
 ar&inodot;yoruz.
 
 
 
 
 
 Bu pozisyon, mezenkimal k&ouml;k h&uuml;creler, eksozomlar, imm&uuml;noterap&ouml;tikler ve doku greftleri gibi &uuml;r&uuml;nlerin geli&scedil;tirilmesinde aktif rol oynayacak, ara&scedil;t&inodot;rma temelli &uuml;retim s&uuml;re&ccedil;lerinin optimize edilmesinde g&ouml;rev alacakt&inodot;r. Aday&inodot;n h&uuml;cre k&uuml;lt&uuml;r&uuml;, molek&uuml;ler biyoloji teknikleri (&ouml;zellikle qPCR ve primer tasar&inodot;m&inodot;), downstream analizler (protein d&uuml;zeyinde analizler vb.) ve GMP s&uuml;re&ccedil;lerine h&acirc;kim olmas&inodot; beklenmektedir. &uuml;r&uuml;n ya&scedil;am d&ouml;ng&uuml;s&uuml;n&uuml;n fikir a&scedil;amas&inodot;ndan validasyon ve teknoloji transferine kadar olan t&uuml;m ad&inodot;mlar&inodot;nda g&ouml;rev alarak, Stembio&rsquo;nun yenilik&ccedil;i &uuml;r&uuml;n portf&ouml;y&uuml;ne katk&inodot; sa&gbreve;lama imk&acirc;n&inodot; sunar.
 
 
 
 
 
 Bu rol, r&uuml;n ya&scedil;am d&ouml;ng&uuml;s&uuml;n&uuml;n fikir a&scedil;amas&inodot;ndan validasyon ve teknoloji transferine kadar olan t&uuml;m ad&inodot;mlar&inodot;nda g&ouml;rev alarak, Stembio&rsquo;nun yenilik&ccedil;i &uuml;r&uuml;n portf&ouml;y&uuml;ne katk&inodot; sa&gbreve;lama imk&acirc;n&inodot; sunar.
 
 
 
 
 
 E&gbreve;er
 
 ileri h&uuml;cresel tedavilerde kalite kontrol&uuml;ne tutkuyla ba&gbreve;l&inodot;ysan&inodot;z
 
 ve en y&uuml;ksek standartlar&inodot; koruma konusunda yetkin oldu&gbreve;unuzu d&uuml;&scedil;&uuml;n&uuml;yorsan&inodot;z, ba&scedil;vurunuzu bekliyoruz!
 
 
 
 
 
 
 Genel Nitelikler
 
 
 
 
 
 <ul>
 <li>
 
 Molek&uuml;ler Biyoloji, Genetik, Biyoloji
 
 veya ilgili di&gbreve;er ya&scedil;am bilimleri alanlar&inodot;nda
 
 lisans veya y&uuml;ksek lisans
 
 derecesine sahip olmak.
 </li>
 <li>
 
 H&uuml;cre k&uuml;lt&uuml;r&uuml;
 
 tekniklerinde uygulamal&inodot; deneyim sahibi olmak (MSCs, primer h&uuml;creler veya kanser h&uuml;cre hatlar&inodot;yla &ccedil;al&inodot;&scedil;ma tercih sebebidir).
 </li>
 <li>
 
 Ger&ccedil;ek zamanl&inodot; PCR (qPCR)
 
 ve
 
 primer tasar&inodot;m&inodot;
 
 konular&inodot;nda deneyim sahibi olmak; ilgili analiz yaz&inodot;l&inodot;mlar&inodot;n&inodot; (&ouml;rne&gbreve;in: Primer3, NCBI, Bio-Rad CFX Maestro) kullanabiliyor olmak.
 </li>
 <li>
 
 Downstream analiz tekniklerine
 
 (&ouml;rne&gbreve;in: Western blot, ELISA, flow sitometri) a&scedil;ina olmak ve aktif kullanabiliyor olmak.
 </li>
 <li>
 Laboratuvar ortam&inodot;nda en az
 
 2 y&inodot;l deneyim
 
 sahibi olmak; GMP veya GLP ortam&inodot;nda &ccedil;al&inodot;&scedil;m&inodot;&scedil; olmak avantaj sa&gbreve;lar.
 </li>
 <li>
 Temel d&uuml;zeyde deney tasar&inodot;m&inodot;, veri analizi ve bilimsel dok&uuml;mantasyon (SOP, teknik rapor, validasyon formu) haz&inodot;rlama becerisi g&ouml;sterebilmek.
 </li>
 <li>
 Sorumluluk bilinci y&uuml;ksek, dikkatli ve disiplinli &ccedil;al&inodot;&scedil;ma al&inodot;&scedil;kanl&inodot;&gbreve;&inodot;na sahip olmak.
 </li>
 <li>
 Tak&inodot;m &ccedil;al&inodot;&scedil;mas&inodot;na yatk&inodot;n, gerekti&gbreve;inde ba&gbreve;&inodot;ms&inodot;z &ccedil;al&inodot;&scedil;abilen ve teknik sorunlara &ccedil;&ouml;z&uuml;m odakl&inodot; yakla&scedil;abilen.
 </li>
 <li>
 Yeni y&ouml;ntem ve teknolojileri &ouml;&gbreve;renmeye istekli, geli&scedil;ime a&ccedil;&inodot;k ve bilimsel yenilikleri takip eden.
 </li>
 <li>
 Yaz&inodot;l&inodot; ve s&ouml;zl&uuml; ileti&scedil;im becerileri geli&scedil;mi&scedil;; tercihen temel d&uuml;zeyde &Idot;ngilizce literat&uuml;r takip edebilen.
 </li>
 </ul>
 
 
 
 
 
 Rol ve Sorumluluklar
 
 
 
 
 
 <ul>
 <li>
 H&uuml;cresel ve molek&uuml;ler d&uuml;zeyde &uuml;r&uuml;n geli&scedil;tirme &ccedil;al&inodot;&scedil;malar&inodot;n&inodot; planlamak, y&uuml;r&uuml;tmek ve optimize etmek.
 </li>
 <li>
 Mezenkimal k&ouml;k h&uuml;creler, eksozomlar ve di&gbreve;er h&uuml;cresel &uuml;r&uuml;nlerin in vitro de&gbreve;erlendirmesini yapmak.
 </li>
 <li>
 H&uuml;cre k&uuml;lt&uuml;r&uuml; i&scedil;lemlerini (pasajlama, dondurma, canl&inodot;l&inodot;k &ouml;l&ccedil;&uuml;m&uuml; vb.) GMP &ouml;n haz&inodot;rl&inodot;k kurallar&inodot;na uygun &scedil;ekilde ger&ccedil;ekle&scedil;tirmek.
 </li>
 <li>
 Molek&uuml;ler biyoloji tekniklerini (&ouml;zellikle
 
 qPCR
 
 ve
 
 primer tasar&inodot;m&inodot;
 
 ) aktif olarak kullanarak gen ekspresyon analizleri y&uuml;r&uuml;tmek.
 </li>
 <li>
 &Uuml;r&uuml;nlerin protein d&uuml;zeyinde analizlerini ger&ccedil;ekle&scedil;tirmek (
 
 Western blot, ELISA, flow sitometri
 
 gibi tekniklerde deneyim sahibi olmak).
 </li>
 <li>
 &Uuml;r&uuml;n prototiplerinin karakterizasyonu ve fonksiyonel validasyonu i&ccedil;in deneysel planlamalar yapmak.
 </li>
 <li>
 &Uuml;retim s&uuml;re&ccedil;lerine bilimsel veri ve Ar-Ge &ccedil;&inodot;kt&inodot;lar&inodot; ile katk&inodot; sa&gbreve;layarak s&uuml;re&ccedil; optimizasyonlar&inodot;nda g&ouml;rev almak.
 </li>
 <li>
 Geli&scedil;tirilen &uuml;r&uuml;nlerin teknoloji transfer s&uuml;re&ccedil;lerinde teknik dok&uuml;mantasyon deste&gbreve;i sa&gbreve;lamak.
 </li>
 <li>
 &Ccedil;al&inodot;&scedil;malarla ilgili
 
 SOP, teknik rapor, deney plan&inodot;
 
 ve validasyon belgeleri haz&inodot;rlamak.
 </li>
 <li>
 Kalite G&uuml;vence (QA) ve Kalite Kontrol (QC) ekipleri ile i&scedil; birli&gbreve;i i&ccedil;inde &ccedil;al&inodot;&scedil;arak &uuml;r&uuml;n g&uuml;venilirli&gbreve;ini art&inodot;rmak.
 </li>
 <li>
 G&uuml;ncel bilimsel yay&inodot;nlar&inodot; ve sekt&ouml;rel geli&scedil;meleri takip ederek yenilik&ccedil;i yakla&scedil;&inodot;mlar&inodot; proje s&uuml;re&ccedil;lerine entegre etmek.
 </li>
 </ul>
 
 
 
 
 
 
 
 
 Ki&scedil;isel verileriniz, i&scedil; ba&scedil;vurunuzun al&inodot;nmas&inodot; ve de&gbreve;erlendirmesi amac&inodot;yla i&scedil;lenmektedir. &Idot;&scedil;lenen ki&scedil;isel verilerinize ve haklar&inodot;n&inodot;za ili&scedil;kin detayl&inodot; bilgilere websitemizin &ldquo;&Idot;nsan Kaynaklar&inodot;&rdquo; ba&scedil;l&inodot;&gbreve;&inodot; i&ccedil;erisinde yer alan&ldquo;&Ccedil;al&inodot;&scedil;an Aday&inodot; Ayd&inodot;nlatma Metni&rsquo;nden ula&scedil;abilirsiniz.
 
 
 
 
 
 
 -------------------------------------------------------------------------------------------------------------
 
 
 
 
 
 Stembio (a Koc Holding/Koc Healthcare company) is a cutting-edge cGMP laboratory specializing in the production and preparation of Mesenchymal Stem Cells (MSCs), Exosomes, Immunotherapy Products, Cord Blood Banking, and Tissue Grafts. We are committed to delivering high-quality, regulatory-compliant cell therapy products through rigorous quality control and validation processes.
 
 
 
 
 
 We are seeking a motivated and detail-oriented
 
 Product Development Specialist (R&amp;D Specialist)
 
 for
 
 Stembio
 
 to support our research and development efforts focused on advanced cellular therapy products. This position will play a key role in developing, optimizing, and validating new cell-based products such as mesenchymal stem cells (MSCs), exosomes, immunotherapeutics, and tissue grafts. The ideal candidate will have hands-on experience in cell culture, molecular biology techniques (particularly qPCR and primer design), and be knowledgeable in downstream protein analysis methods.
 
 
 
 
 
 The role offers an exciting opportunity to contribute at all stages of the product lifecycle, from concept development to validation and tech transfer, in a cutting-edge, GMP-aligned laboratory environment.
 
 
 
 
 
 If you are passionate about quality control in advanced cell therapies and have the expertise to uphold the highest standards, we encourage you to apply!
 
 
 
 
 
 
 Qualifications
 
 
 
 
 
 <ul>
 <li>
 Bachelor's or Master&rsquo;s degree in
 
 Molecular Biology, Genetics, Biology,
 
 or a related life sciences field.
 </li>
 <li>
 Minimum of
 
 2 years of laboratory experience
 
 in academia or industry; experience in GMP or GLP settings is a plus.
 </li>
 <li>
 Proven hands-on experience in
 
 cell culture techniques
 
 , preferably with MSCs or primary cells.
 </li>
 <li>
 Strong proficiency in
 
 qPCR applications and primer design
 
 ; familiarity with tools like Primer3, NCBI, or Bio-Rad CFX software is preferred.
 </li>
 <li>
 Practical knowledge of
 
 downstream techniques
 
 such as
 
 Western blotting, ELISA, and flow cytometry
 
 .
 </li>
 <li>
 Ability to design experiments, analyze data, and document scientific findings clearly and accurately.
 </li>
 <li>
 Strong sense of responsibility, attention to detail, and ability to follow protocols precisely.
 </li>
 <li>
 Capable of working both independently and as part of a multidisciplinary team.
 </li>
 <li>
 Eagerness to learn and implement new techniques and a passion for scientific innovation.
 </li>
 <li>
 Good communication skills; ability to follow English-language protocols and scientific literature is desirable.
 </li>
 </ul>
 
 
 
 
 
 Key Responsibilities
 
 
 
 
 
 <ul>
 <li>
 Plan, execute, and optimize
 
 in vitro assays
 
 to support product development activities.
 </li>
 <li>
 Perform cell culture operations including
 
 passaging, cryopreservation, and viability assays
 
 .
 </li>
 <li>
 Conduct
 
 qPCR and gene expression analyses
 
 , including
 
 primer design and optimization
 
 .
 </li>
 <li>
 Apply
 
 downstream molecular and protein analysis techniques
 
 (e.g.,
 
 Western blot, ELISA, flow cytometry
 
 ).
 </li>
 <li>
 Characterize and validate prototypes for functionality and quality in line with project goals.
 </li>
 <li>
 Contribute scientific data and experimental outputs to
 
 process optimization and scale-up strategies
 
 .
 </li>
 <li>
 Prepare and maintain technical documentation such as
 
 SOPs, experimental plans, and validation protocols
 
 .
 </li>
 <li>
 Collaborate with QA, QC, and manufacturing teams for
 
 knowledge transfer
 
 and alignment with GMP standards.
 </li>
 <li>
 Monitor scientific literature and industry trends to incorporate innovative techniques into development workflows.
 </li>
 </ul>
 
 
 
 
 
 Your personal data is processed for the purpose of receiving and evaluating your job application. You can find detailed information about your processed personal data and rights from the "Employee Candidate Clarification Text" under the "Human Resources" heading of our website.
 
 
</div>

Stembio - Ürün Geliştirme Uzmanı / Product Development Specialist

<div>
 
 Stembio (
 
 Ko&ccedil; Holding/Ko&ccedil; Healthcare
 
 i&scedil;tiraki),
 
 Mezenkimal K&ouml;k H&uuml;creler (MSC), Eksozomlar, &Idot;mm&uuml;noterapi &Uuml;r&uuml;nleri, Kordon Kan&inodot; Bankalama ve Doku Greftleri
 
 &uuml;retimi ve haz&inodot;rlanmas&inodot; konusunda uzmanla&scedil;m&inodot;&scedil;, ileri teknolojiye sahip bir
 
 cGMP laboratuvar&inodot;d&inodot;r
 
 . Kalite kontrol ve validasyon s&uuml;re&ccedil;lerine b&uuml;y&uuml;k &ouml;nem vererek,
 
 y&uuml;ksek kaliteli ve reg&uuml;lasyonlara uygun
 
 h&uuml;cresel tedavi &uuml;r&uuml;nleri sunmay&inodot; taahh&uuml;t ediyoruz.
 
 
 
 
 
 Laboratuvar ekipleri ile sat&inodot;&scedil;/ticari ekipleri aras&inodot;nda k&ouml;pr&uuml; g&ouml;revi g&ouml;recek, teknik kabiliyetleri pazara haz&inodot;r &uuml;r&uuml;nlere d&ouml;n&uuml;&scedil;t&uuml;recek, ticarile&scedil;tirme stratejilerini destekleyecek ve Ar-Ge, Kalite, &Uuml;retim ve Sat&inodot;&scedil; departmanlar&inodot; aras&inodot;nda etkin ileti&scedil;imi sa&gbreve;lamaktan sorumlu
 
 Stembio
 
 'da g&ouml;revlendirilmek &uuml;zere bir
 
 &Uuml;r&uuml;n Y&ouml;neticisi
 
 aray&inodot;&scedil;&inodot;nday&inodot;z.
 
 
 
 
 
 E&gbreve;er bilimsel anlay&inodot;&scedil;, pazar bilgisi ve proje y&ouml;netimi becerilerini birle&scedil;tirerek &uuml;r&uuml;nlerin laboratuvardan pazara ba&scedil;ar&inodot;yla ula&scedil;mas&inodot; konusunda yetkin oldu&gbreve;unuzu d&uuml;&scedil;&uuml;n&uuml;yorsan&inodot;z, ba&scedil;vurunuzu bekliyoruz!
 
 
 
 
 
 
 Genel Nitelikler
 
 
 
 
 
 <ul>
 <li>
 Ya&scedil;am Bilimleri, Biyoteknoloji, Eczac&inodot;l&inodot;k, Biyomedikal M&uuml;hendisli&gbreve;i veya ilgili alanlarda lisans veya &uuml;zeri derece.
 </li>
 <li>
 Biyoteknoloji, ila&ccedil; veya t&inodot;bbi cihaz sekt&ouml;r&uuml;nde &uuml;r&uuml;n y&ouml;netimi veya fonksiyonlar aras&inodot; koordinasyon alan&inodot;nda en az 3&ndash;5 y&inodot;l deneyim.
 </li>
 <li>
 ATMP&rsquo;ler, h&uuml;cre terapileri ve t&inodot;bbi cihaz &uuml;r&uuml;nleri hakk&inodot;nda g&uuml;&ccedil;l&uuml; teknik bilgi.
 </li>
 <li>
 Teknik/bilimsel bilgileri ticari stratejilere d&ouml;n&uuml;&scedil;t&uuml;rme konusunda deneyim.
 </li>
 <li>
 T&uuml;rk&ccedil;e ve &Idot;ngilizce ileti&scedil;im becerileri y&uuml;ksek, &ccedil;ok disiplinli ekiplerle &ccedil;al&inodot;&scedil;abilme yetene&gbreve;ine sahip.
 </li>
 <li>
 Proaktif, d&uuml;zenli ve dinamik ortamlarda karma&scedil;&inodot;k projeleri y&ouml;netme becerisine sahip.
 </li>
 <li>
 GMP, reg&uuml;lasyon gereklilikleri ve klinik s&uuml;re&ccedil;lere a&scedil;inal&inodot;k avantaj sa&gbreve;lar.
 </li>
 </ul>
 
 
 
 
 
 Rol ve Sorumluluklar
 
 
 
 
 
 
 
 &Uuml;r&uuml;n Ya&scedil;am D&ouml;ng&uuml;s&uuml; Y&ouml;netimi
 
 
 <ul>
 <li>
 Stembio&rsquo;nun ATMP, t&inodot;bbi cihaz ve biyolojik &uuml;r&uuml;n portf&ouml;y&uuml; i&ccedil;in &uuml;r&uuml;n yol haritalar&inodot;n&inodot; tan&inodot;mlamak ve y&ouml;netmek.
 </li>
 <li>
 Laboratuvar inovasyonlar&inodot;n&inodot;, belirgin de&gbreve;er teklifleriyle ticari olarak uygulanabilir &uuml;r&uuml;nlere d&ouml;n&uuml;&scedil;t&uuml;rmek.
 </li>
 <li>
 Laboratuvar kabiliyetlerini, pazar gereksinimleri ve d&uuml;zenleyici standartlarla uyumlu hale getirerek &uuml;r&uuml;n lansmanlar&inodot;n&inodot; desteklemek.
 </li>
 </ul>
 
 
 Fonksiyonlar Aras&inodot; Koordinasyon
 
 
 <ul>
 <li>
 Ar-Ge, Kalite, &Uuml;retim ve Sat&inodot;&scedil; ekipleri aras&inodot;nda ana ileti&scedil;im noktas&inodot; olarak g&ouml;rev almak.
 </li>
 <li>
 Laboratuvar g&uuml;ncellemeleri, &uuml;r&uuml;n &ouml;zellikleri ve geli&scedil;tirme takvimlerinin ticari ekiplere etkin bi&ccedil;imde aktar&inodot;lmas&inodot;n&inodot; sa&gbreve;lamak.
 </li>
 <li>
 Sat&inodot;&scedil; ve m&uuml;&scedil;teri geri bildirimlerini Ar-Ge ve &uuml;retim planlamas&inodot;na y&ouml;nelik aksiyon al&inodot;nabilir i&ccedil;g&ouml;r&uuml;lere d&ouml;n&uuml;&scedil;t&uuml;rmek.
 </li>
 </ul>
 
 
 Pazar ve M&uuml;&scedil;teri Analizi
 
 
 <ul>
 <li>
 Yeni trendleri, m&uuml;&scedil;teri ihtiya&ccedil;lar&inodot;n&inodot; ve rekabet ortam&inodot;n&inodot; belirlemek amac&inodot;yla pazar ara&scedil;t&inodot;rmalar&inodot; y&uuml;r&uuml;tmek.
 </li>
 <li>
 &Uuml;r&uuml;nlerin teknik &ouml;zelliklerini do&gbreve;ru yans&inodot;tan pazarlama ve sat&inodot;&scedil; materyallerinin haz&inodot;rlanmas&inodot;na destek olmak.
 </li>
 <li>
 Sat&inodot;&scedil; ekibine teknik &uuml;r&uuml;n sunumlar&inodot; ve m&uuml;&scedil;teri g&ouml;r&uuml;&scedil;melerinde destek sa&gbreve;lamak.
 </li>
 </ul>
 
 
 Reg&uuml;lasyon ve Kalite Deste&gbreve;i
 
 
 <ul>
 <li>
 &Uuml;r&uuml;nlerin ulusal ve uluslararas&inodot; standartlara uygunlu&gbreve;unu sa&gbreve;lamak i&ccedil;in Reg&uuml;lasyon ve Kalite G&uuml;vence ekipleriyle yak&inodot;n &ccedil;al&inodot;&scedil;mak.
 </li>
 <li>
 &Idot;hale, &uuml;r&uuml;n tescili ve klinik ba&scedil;vurular i&ccedil;in gerekli dok&uuml;mantasyon s&uuml;re&ccedil;lerine destek olmak.
 </li>
 </ul>
 
 
 Proje Y&ouml;netimi
 
 
 <ul>
 <li>
 &Uuml;r&uuml;n geli&scedil;tirme takvimlerini takip ederek laboratuvar ve ticari ekipler aras&inodot;ndaki kilometre ta&scedil;lar&inodot;n&inodot;n zaman&inodot;nda tamamlanmas&inodot;n&inodot; sa&gbreve;lamak.
 </li>
 <li>
 &Idot;&ccedil; toplant&inodot;lar, &uuml;r&uuml;n g&uuml;ncellemeleri ve fonksiyonlar aras&inodot; &ccedil;al&inodot;&scedil;taylar&inodot;n koordinasyonunu sa&gbreve;lamak.
 </li>
 <li>
 Lansman sonras&inodot; &uuml;r&uuml;n performans&inodot;n&inodot; izlemek ve s&uuml;rekli iyile&scedil;tirme aksiyonlar&inodot; &ouml;nermek.
 </li>
 </ul>
 
 
 
 
 
 Ki&scedil;isel verileriniz, i&scedil; ba&scedil;vurunuzun al&inodot;nmas&inodot; ve de&gbreve;erlendirmesi amac&inodot;yla i&scedil;lenmektedir. &Idot;&scedil;lenen ki&scedil;isel verilerinize ve haklar&inodot;n&inodot;za ili&scedil;kin detayl&inodot; bilgilere websitemizin &ldquo;&Idot;nsan Kaynaklar&inodot;&rdquo; ba&scedil;l&inodot;&gbreve;&inodot; i&ccedil;erisinde yer alan&ldquo;&Ccedil;al&inodot;&scedil;an Aday&inodot; Ayd&inodot;nlatma Metni&rsquo;nden ula&scedil;abilirsiniz.
 
 
 
 
 
 
 -------------------------------------------------------------------------------------------------------------
 
 
 
 
 
 Stembio (a Koc Holding/Koc Healthcare company) is a cutting-edge cGMP laboratory specializing in the production and preparation of Mesenchymal Stem Cells (MSCs), Exosomes, Immunotherapy Products, Cord Blood Banking, and Tissue Grafts. We are committed to delivering high-quality, regulatory-compliant cell therapy products through rigorous quality control and validation processes.
 
 
 
 
 
 We are seeking for a qualified and experienced
 
 Product Manager for Stembio,
 
 who will be responsible for translating technical capabilities into market-ready products, supporting commercialization strategies, and ensuring clear communication between R&amp;D, Quality, Production, and Sales, to serve as the critical link between Stembio&rsquo;s laboratory teams and the sales/commercial teams.
 
 
 
 
 
 If you are passionate about combining scientific understanding, market insight, and project management skills to drive product success from lab to market, we encourage you to apply!
 
 
 
 
 
 
 Qualifications
 
 
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s or higher degree in Life Sciences, Biotechnology, Pharmacy, Biomedical Engineering, or related field.
 </li>
 <li>
 Minimum 3&ndash;5 years of experience in product management or cross-functional coordination in the biotech, pharma, or medical device sector.
 </li>
 <li>
 Strong understanding of ATMPs, cell therapies, and medical device products.
 </li>
 <li>
 Experience translating technical/scientific information into commercial strategies.
 </li>
 <li>
 Excellent communication skills in Turkish and English, with the ability to work across multiple teams.
 </li>
 <li>
 Proactive, organized, and capable of managing complex projects in a dynamic environment.
 </li>
 <li>
 Familiarity with regulatory requirements, GMP, and clinical trial processes is an advantage.
 </li>
 </ul>
 
 
 
 
 
 Key Responsibilities
 
 
 
 
 
 
 
 Product Lifecycle Management
 
 
 <ul>
 <li>
 Define and manage product roadmaps for Stembio&rsquo;s portfolio, including ATMPs, medical devices, and biologics.
 </li>
 <li>
 Translate laboratory innovations into commercially viable products with clear value propositions.
 </li>
 <li>
 Support product launches by aligning lab capabilities with market requirements and regulatory needs.
 </li>
 </ul>
 
 
 Cross-Functional Coordination
 
 
 <ul>
 <li>
 Serve as the primary liaison between R&amp;D, Quality, Production, and Sales teams.
 </li>
 <li>
 Ensure that laboratory updates, product capabilities, and development timelines are effectively communicated to commercial teams.
 </li>
 <li>
 Translate sales and customer feedback into actionable insights for R&amp;D and production planning.
 </li>
 </ul>
 
 
 Market &amp; Customer Insight
 
 
 <ul>
 <li>
 Conduct market research to identify emerging trends, customer needs, and competitive landscape.
 </li>
 <li>
 Provide support in creating marketing and sales materials that accurately reflect technical product features.
 </li>
 <li>
 Assist the sales team in technical product presentations and customer discussions.
 </li>
 </ul>
 
 
 Regulatory &amp; Quality Support
 
 
 <ul>
 <li>
 Work closely with Regulatory Affairs and QA teams to ensure that products meet national and international standards.
 </li>
 <li>
 Support documentation for tenders, product registrations, and clinical applications as needed.
 </li>
 </ul>
 
 
 Project Management
 
 
 <ul>
 <li>
 Track product development timelines and ensure milestones are met across lab and commercial teams.
 </li>
 <li>
 Coordinate internal meetings, product updates, and cross-functional workshops to maintain alignment.
 </li>
 <li>
 Monitor product performance post-launch and suggest continuous improvement actions.
 </li>
 </ul>
 
 
 
 
 
 Your personal data is processed for the purpose of receiving and evaluating your job application. You can find detailed information about your processed personal data and rights from the "Employee Candidate Clarification Text" under the "Human Resources" heading of our website.
 
 
 
 
</div>

Stembio - Ürün Yöneticisi / Product Manager

<div>
 
 GENEL N&Idot;TEL&Idot;KLER VE &Idot;&Scedil; TANIMI
 
 
 Vehbi Ko&ccedil; Vakf&inodot; Sa&gbreve;l&inodot;k Kurulu&scedil;lar&inodot;, Global Fortune 500 listesindeki tek T&uuml;rk &scedil;irketi olan Ko&ccedil; Toplulu&gbreve;u&rsquo;na ba&gbreve;l&inodot; hizmet veren, kar amac&inodot; g&uuml;tmeyen hastaneler grubudur. Amerikan Hastanesi, Amerikan T&inodot;p Merkezi, Ko&ccedil; &Uuml;niversitesi Hastanesi, Bodrum Amerikan Hastanesi, VetAmerikan ve Ko&ccedil; Sa&gbreve;l&inodot;k Yan&inodot;mda olarak Vehbi Ko&ccedil; Vakf&inodot; Sa&gbreve;l&inodot;k Kurulu&scedil;lar&inodot; &ccedil;at&inodot;s&inodot; alt&inodot;nda hizmet vermekteyiz.
 
 
 &Idot;nsan kayna&gbreve;&inodot;m&inodot;z&inodot;n en de&gbreve;erli varl&inodot;&gbreve;&inodot;m&inodot;z oldu&gbreve;unu biliyor, nitelikli insan kayna&gbreve;&inodot;m&inodot;z&inodot; art&inodot;rmak i&ccedil;in s&uuml;rekli yat&inodot;r&inodot;mda bulunuyoruz. Belirledi&gbreve;imiz klinik yol, rehber ve talimatlarla her sene 500.000&rsquo;den fazla hastaya ayn&inodot; kalitede g&uuml;venilir, &scedil;effaf ve kapsaml&inodot; tan&inodot;, tedavi ve bak&inodot;m hizmeti sunuyoruz. Her ge&ccedil;en y&inodot;l &ccedil;al&inodot;&scedil;an ba&gbreve;l&inodot;l&inodot;&gbreve;&inodot; endeksinin art&inodot;&scedil; g&ouml;sterdi&gbreve;i kurumlar&inodot;m&inodot;za yeni &uuml;yelerin kat&inodot;lacak olmas&inodot;ndan &ouml;t&uuml;r&uuml; heyecan duyuyoruz.
 
 
 
 
 
 Genel Nitelikler
 
 <ul>
 <li>
 Modern frontend teknolojilerine (React, TypeScript, CSS-in-JS/Tailwind) hakim
 </li>
 <li>
 Kod kalitesine, performansa ve kullan&inodot;c&inodot; deneyimine &ouml;nem veren
 </li>
 <li>
 &Uuml;niversitelerin ilgili b&ouml;l&uuml;mlerinden mezun
 </li>
 <li>
 En az 3 y&inodot;l frontend geli&scedil;tirme deneyimi
 </li>
 <li>
 HTML5, CSS3 (Flexbox, Grid) ve modern JavaScript (ES6+) konusunda ileri seviye bilgi sahibi
 </li>
 <li>
 Responsive tasar&inodot;m ve taray&inodot;c&inodot;/mobil uyumluluk konular&inodot;nda deneyimli
 </li>
 <li>
 Web standartlar&inodot;na ve W3C kriterlerine uygun, eri&scedil;ilebilir (accessibility) ve performansl&inodot; aray&uuml;z geli&scedil;tirme konusunda deneyimli
 </li>
 <li>
 UI/UX ve g&ouml;rsel tasar&inodot;m prensiplerine hakim (tipografi, sayfa d&uuml;zeni, men&uuml;/navigasyon mant&inodot;&gbreve;&inodot;, tasar&inodot;m b&uuml;t&uuml;nl&uuml;&gbreve;&uuml; vb.)
 </li>
 <li>
 Strapi tabanl&inodot; i&ccedil;erik y&ouml;netim sistemleri &uuml;zerinde geli&scedil;tirme yapma deneyimine sahip
 </li>
 <li>
 SEO uyumlu aray&uuml;z geli&scedil;tirme konusunda deneyimli
 </li>
 <li>
 Alan&inodot;ndaki yeni teknolojileri yak&inodot;ndan takip eden ve uygulamaya aktaran
 </li>
 <li>
 Tak&inodot;m &ccedil;al&inodot;&scedil;mas&inodot;na yatk&inodot;n, sorumluluk sahibi ve analitik d&uuml;&scedil;&uuml;nme becerisine sahip
 </li>
 <li>
 Ekstra avantaj say&inodot;lacak: .NET platformu, C# ve MVC mimarisi hakk&inodot;nda bilgi sahibi olmak
 </li>
 <li>
 &Idot;leri seviyede &Idot;ngilizce bilgisine sahip
 </li>
 </ul>
 
 
 
 
 &Idot;&scedil; Tan&inodot;m&inodot;
 
 <ul>
 <li>
 Yaz&inodot;l&inodot;m ekibine gelen i&scedil; taleplerinde, tasarlanan g&ouml;rsellerin modern frontend teknolojileriyle kodlanmas&inodot;
 </li>
 <li>
 Web aray&uuml;z standartlar&inodot;n&inodot;n olu&scedil;turulmas&inodot;, uygulanmas&inodot; ve s&uuml;reklili&gbreve;inin sa&gbreve;lanmas&inodot;
 </li>
 <li>
 Gelen taleplerin, g&ouml;rsel tasar&inodot;mlar&inodot;n ve yaz&inodot;l&inodot;m mimarisinin uyumlulu&gbreve;unu kontrol ederek performansl&inodot;, g&uuml;venilir ve kullan&inodot;c&inodot; dostu aray&uuml;zler geli&scedil;tirmek
 </li>
 <li>
 SEO, UX ve eri&scedil;ilebilirlik kriterlerine uygun, t&uuml;m modern taray&inodot;c&inodot;larda sorunsuz &ccedil;al&inodot;&scedil;an &ccedil;&ouml;z&uuml;mler &uuml;retmek
 </li>
 <li>
 Kurumsal tasar&inodot;m sistemi ve component k&uuml;t&uuml;phanesine katk&inodot; sa&gbreve;lamak
 </li>
 </ul>
 
 
 
 
 Seni Neler Bekliyor?
 
 <ul>
 <li>
 G&uuml;&ccedil;l&uuml; kurum k&uuml;lt&uuml;r&uuml; ile birlikte ayn&inodot; hedefe ko&scedil;an tutkulu &ccedil;al&inodot;&scedil;ma arkada&scedil;lar&inodot; ve &scedil;effaf y&ouml;netim anlay&inodot;&scedil;&inodot;yla &ccedil;al&inodot;&scedil;an mutlulu&gbreve;unun &ouml;n planda tutuldu&gbreve;u bir &ccedil;al&inodot;&scedil;ma ortam&inodot;
 </li>
 <li>
 Ko&ccedil; Akademi, E-nocta ve d&uuml;nyaca &uuml;nl&uuml; platformlardan s&uuml;rekli &ouml;&gbreve;renmene yard&inodot;mc&inodot; olacak online/s&inodot;n&inodot;fi&ccedil;i e&gbreve;itimler ve daha fazlas&inodot;
 </li>
 <li>
 Anla&scedil;mal&inodot; kurumlarla y&uuml;ksek lisans f&inodot;rsatlar&inodot;
 </li>
 <li>
 G&uuml;&ccedil;l&uuml; yan haklar ve sosyal yard&inodot;mlar
 </li>
 <li>
 &Idot;&scedil; ya&scedil;am dengesi ve sosyalle&scedil;meye y&ouml;nelik kul&uuml;pler, Code Lotus mindfulness merkezi
 </li>
 <li>
 Ko&ccedil; toplulu&gbreve;u &ccedil;al&inodot;&scedil;anlar&inodot;na &ouml;zel Ko&ccedil; Ailem Kart&inodot;yla aileden gelen ayr&inodot;cal&inodot;klar
 </li>
 <li>
 Fark yaratan &ccedil;al&inodot;&scedil;malar i&ccedil;in Anl&inodot;k &Ouml;d&uuml;ller
 </li>
 </ul>
 
 
 
 
 
 
 Ki&scedil;isel verileriniz, i&scedil; ba&scedil;vurunuzun al&inodot;nmas&inodot; ve de&gbreve;erlendirmesi amac&inodot;yla i&scedil;lenmektedir. &Idot;&scedil;lenen ki&scedil;isel verilerinize ve haklar&inodot;n&inodot;za ili&scedil;kin detayl&inodot; bilgilere websitemizin &ldquo;&Idot;nsan Kaynaklar&inodot;&rdquo; ba&scedil;l&inodot;&gbreve;&inodot; i&ccedil;erisinde yer alan&ldquo;&Ccedil;al&inodot;&scedil;an Aday&inodot; Ayd&inodot;nlatma Metni&rsquo;nden ula&scedil;abilirsiniz.
 
 
 
 
 
</div>

Arayüz Uygulama Geliştirme Uzmanı

<div>
 
 Stembio (a Koc Holding/Koc Healthcare company) is a cutting-edge cGMP laboratory specializing in the production and preparation of cellular products such as CAR-T/TILs, Mesenchymal Stem Cells (MSCs), exosomes, immunotherapy products, cord blood banking and tissue grafts. We are committed to delivering high-quality, regulatory-compliant cell therapy products through rigorous quality control and validation processes.
 
 
 
 
 
 We are seeking a highly skilled and motivated
 
 Quality Assurance (QA) Expert for Stembio
 
 to ensure compliance with cGMP, regulatory requirements, and company quality standards for our cell therapy products.
 
 
 
 
 
 The QA Expert will oversee quality management systems, support regulatory audits, manage deviations, and drive continuous improvement initiatives. The ideal candidate will have a strong background in quality assurance, risk management, and compliance within a cGMP-regulated environment.
 
 
 
 
 
 If you are passionate about quality assurance in advanced cell therapies and have the expertise to uphold the highest standards, we encourage you to apply!
 
 
 
 
 
 
 Qualifications
 
 
 
 
 
 <ul>
 <li>
 Master&rsquo;s degree or higher in Biology, Biotechnology, Biochemistry, or a related field.
 </li>
 <li>
 Minimum of 3+ years of experience in a cGMP-regulated Quality Assurance environment, preferably in cell therapy, regenerative medicine, or biopharmaceuticals.
 </li>
 <li>
 Strong knowledge of quality assurance principles, risk management, and regulatory compliance (EMA, TITCK, FDA, ICH guidelines).
 </li>
 <li>
 Experience in managing QMS, deviation handling, CAPA, and change control processes.
 </li>
 <li>
 Ability to interpret and apply regulatory guidelines and quality standards to ensure compliance.
 </li>
 <li>
 Excellent analytical, problem-solving, and decision-making skills.
 </li>
 <li>
 Strong communication and leadership skills, with the ability to work independently and in a team.
 </li>
 <li>
 Experience with electronic QMS, document control systems, and LIMS is a plus.
 </li>
 </ul>
 
 
 
 
 
 Key Responsibilities
 
 
 
 
 
 <ul>
 <li>
 Ensure compliance with cGMP, EMA, TITCK, and other relevant regulatory requirements for cell therapy products.
 </li>
 <li>
 Develop, implement, and maintain Quality Management Systems (QMS), including deviation management, CAPA, change control, and risk assessments.
 </li>
 <li>
 Support and participate in regulatory inspections, audits, and internal quality reviews.
 </li>
 <li>
 Review and approve SOPs, batch records, validation protocols, and quality-related documents.
 </li>
 <li>
 Conduct investigations for deviations, out-of-specification (OOS) results, and non-conformances, ensuring timely resolution and implementation of corrective and preventive actions (CAPAs).
 </li>
 <li>
 Oversee the training program to ensure all personnel are adequately trained in quality procedures and regulatory requirements.
 </li>
 <li>
 Collaborate with cross-functional teams including Quality Control (QC), Production, and Regulatory Affairs to maintain high-quality standards.
 </li>
 <li>
 Monitor and improve quality metrics to ensure continuous improvement of quality systems and processes.
 </li>
 <li>
 Manage supplier and raw material quality assurance, including vendor qualification and material release processes.
 </li>
 <li>
 Ensure timely approval and release of raw materials, intermediates, and final products based on quality assurance criteria.
 </li>
 </ul>
 
 
 
 
 
 Your personal data is processed for the purpose of receiving and evaluating your job application. You can find detailed information about your processed personal data and rights from the "Employee Candidate Clarification Text" under the "Human Resources" heading of our website.
 
 
 
 
</div>

Stembio - Quality Assurance (QA) Expert

Join Amerikan Hastanesi and explore 7   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.