Qureos Mentor

Amerikan Hastanesi

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 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.
 
 
 
 
 
 Farkl&inodot; kaynaklardan mezenkimal k&ouml;k h&uuml;crelerin &uuml;retimi, imm&uuml;noterapi &uuml;r&uuml;nleri (sitokinle ind&uuml;klenmi&scedil; &ouml;ld&uuml;r&uuml;c&uuml; h&uuml;creler, dendritik h&uuml;creler), fibroblast h&uuml;crelerinin &uuml;retimi ve h&uuml;cre k&uuml;lt&uuml;r&uuml; s&uuml;re&ccedil;lerinin takibi ve &uuml;r&uuml;n haz&inodot;rlanmas&inodot;nda g&ouml;rev alacak,
 
 Stembio
 
 'da g&ouml;revlendirilmek &uuml;zere kalifiye ve deneyimli bir
 
 &Uuml;retim Personeli
 
 ar&inodot;yoruz.
 
 
 
 
 
 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>
 Biyoloji, Biyom&uuml;hendislik, Biyoteknoloji, Molek&uuml;ler Biyoloji veya ilgili bir alanda en az Y&uuml;ksek Lisans mezunu,
 </li>
 <li>
 Tercihen iyi seviyede &Idot;ngilizce dil bilgisi bulunan (okuma ve yazma),
 </li>
 <li>
 cGMP d&uuml;zenlemelerine tabi bir &uuml;retim ortam&inodot;nda en az 2 y&inodot;l ve &uuml;zeri deneyimi bulunan (tercihen h&uuml;cresel tedavi, rejeneratif t&inodot;p veya biyofarmas&ouml;tik sekt&ouml;rlerinde),
 </li>
 <li>
 H&uuml;cre izolasyonu (mezenkimal k&ouml;k h&uuml;cre vb.), h&uuml;cre pasajlanmas&inodot;, h&uuml;cre dondurma, h&uuml;cre k&uuml;lt&uuml;r&uuml; takibi konular&inodot;nda pratik deneyimi bulunan,
 </li>
 <li>
 Validasyon protokollerini &uuml;r&uuml;n&uuml;n geli&scedil;tirilmesi y&ouml;n&uuml;nde etkin bir &scedil;ekilde planlama, planlanan s&uuml;re&ccedil;lerin takibi, raporlanmas&inodot; konular&inodot;nda g&uuml;&ccedil;l&uuml; bilgisi bulunan,
 </li>
 <li>
 Reg&uuml;latif gereklilikler (FDA, EMA, T&Idot;TCK, ICH k&inodot;lavuzlar&inodot;) ve kalite y&ouml;netim sistemleri (QMS) konusunda deneyimi bulunan,
 </li>
 <li>
 Analitik d&uuml;&scedil;&uuml;nme, problem &ccedil;&ouml;zme yetenekleri g&uuml;&ccedil;l&uuml; olan,
 </li>
 <li>
 Ekip &ccedil;al&inodot;&scedil;mas&inodot;na uygun bir &scedil;ekilde planlamalar yaparak s&uuml;reci y&ouml;netme yetkinli&gbreve;i bulunan,
 </li>
 <li>
 Dok&uuml;mantasyon, raporlama ve sunum yapma konusunda ileti&scedil;im becerileri g&uuml;&ccedil;l&uuml; olan,
 </li>
 </ul>
 
 
 
 
 
 Rol ve Sorumluluklar
 
 
 
 
 
 <ul>
 <li>
 &Idot;yi &Uuml;retim Uygulamalar&inodot; (GMP) standartlar&inodot;na uygun &ccedil;al&inodot;&scedil;mak, B s&inodot;n&inodot;f &uuml;retim odalar&inodot;nda &uuml;retim s&uuml;re&ccedil;lerini y&uuml;r&uuml;tmek,
 </li>
 <li>
 &Ccedil;e&scedil;itli dokulardan mezenkimal k&ouml;k h&uuml;crelerin izolasyonunu yapmak,
 </li>
 <li>
 Mezenkimal k&ouml;k h&uuml;crelerin h&uuml;cre k&uuml;lt&uuml;r&uuml;nde takibini yapmak ve h&uuml;creleri &ccedil;o&gbreve;altmak,
 </li>
 <li>
 T h&uuml;cre ve dentritik h&uuml;cre k&uuml;lt&uuml;rlerinde aktif g&ouml;rev almak,
 </li>
 <li>
 Ba&gbreve;&inodot;&scedil;&inodot;kl&inodot;k sistemi h&uuml;crelerinin &uuml;retim s&uuml;re&ccedil;lerinde g&ouml;rev almak,
 </li>
 <li>
 Y&ouml;ntem geli&scedil;tirmeye katk&inodot;da bulunmak, ara&scedil;t&inodot;rmak ve bunun uygulanmas&inodot; i&ccedil;in validasyon &ccedil;al&inodot;&scedil;malar&inodot;n&inodot; ger&ccedil;ekle&scedil;tirmek,
 </li>
 <li>
 T&uuml;m s&uuml;re&ccedil;lerin dok&uuml;mantasyonunda g&ouml;rev almak; SOP, protokoller ve raporlar&inodot; reg&uuml;lasyona uygun &scedil;ekilde yazmak,
 </li>
 <li>
 cGMP, EMA, T&Idot;TCK ve di&gbreve;er reg&uuml;lasyonlara uygunlu&gbreve;u sa&gbreve;lamak,
 </li>
 <li>
 T&uuml;m &uuml;retim s&uuml;re&ccedil;lerinde al&inodot;nan kalite kontrol verilerini incelemek, s&uuml;recin geli&scedil;tirilmesine katk&inodot;da bulunmak,
 </li>
 <li>
 Sapmalar&inodot;, spesifikasyon d&inodot;&scedil;&inodot; (OOS) sonu&ccedil;lar&inodot; ve uygunsuzluklar&inodot; ara&scedil;t&inodot;rmak, gerekli d&uuml;zeltici ve &ouml;nleyici faaliyetleri (CAPA) uygulamak,
 </li>
 <li>
 S&uuml;recin devaml&inodot;l&inodot;&gbreve;&inodot;n&inodot; sa&gbreve;lamak i&ccedil;in uygun planlama ve ekip &ccedil;al&inodot;&scedil;mas&inodot;n&inodot; ger&ccedil;ekle&scedil;tirmek,
 </li>
 <li>
 H&uuml;cresel &uuml;r&uuml;nlerin &uuml;retim s&uuml;re&ccedil;lerinin y&uuml;r&uuml;t&uuml;lmesi,
 </li>
 <li>
 Proses validasyonlar&inodot;na kat&inodot;l&inodot;m sa&gbreve;lamak,
 </li>
 <li>
 cGMP, reg&uuml;lasyonlar ve &scedil;irket standartlar&inodot;na uygunlu&gbreve;u sa&gbreve;lanmak,
 </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.
 
 
 
 
 
 
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 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 qualified and experienced
 
 Production Personnel for Stembio
 
 to be responsible for the production of mesenchymal stem cells from various sources, immunotherapy products (cytokine-induced killer cells, dendritic cells), fibroblast cell production, and monitoring of cell culture processes and product preparation.
 
 
 
 
 
 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>
 A minimum of a Master&rsquo;s degree in Biology, Biomedical Engineering, Biotechnology, Molecular Biology, or a related field.
 </li>
 <li>
 Proficiency in English is a plus
 </li>
 <li>
 At least 2+ years of experience in a cGMP-regulated production environment (preferably in the fields of cell therapy, regenerative medicine, or biopharmaceuticals).
 </li>
 <li>
 Hands-on experience in cell isolation (e.g., mesenchymal stem cells), cell passaging, cell freezing, cell culture monitoring.
 </li>
 <li>
 Strong knowledge in planning validation protocols effectively for product development, tracking planned processes, and reporting outcomes.
 </li>
 <li>
 Experience with regulatory requirements (FDA, EMA, T&Idot;TCK, ICH guidelines) and quality management systems (QMS).
 </li>
 <li>
 Analytical thinking, problem-solving skills.
 </li>
 <li>
 Ability to manage the process by planning effectively within a team-oriented environment.
 </li>
 <li>
 Strong communication skills in documentation, reporting, and presentation.
 </li>
 </ul>
 
 
 
 
 
 Key Responsibilities
 
 
 
 
 
 <ul>
 <li>
 Work in compliance with Good Manufacturing Practices (GMP) standards and execute production processes in Class B manufacturing rooms.
 </li>
 <li>
 Isolate mesenchymal stem cells from various tissues.
 </li>
 <li>
 Monitor mesenchymal stem cells in culture and expand them.
 </li>
 <li>
 Actively participate in T cell and dendritic cell cultures and contribute to the production processes of immune system cells.
 </li>
 <li>
 Contribute to method development, conduct research, and perform validation studies for implementation.
 </li>
 <li>
 Take part in the documentation of all processes; write SOPs, protocols, and reports in compliance with regulations.
 </li>
 <li>
 Ensure compliance with cGMP, EMA, T&Idot;TCK, and other relevant regulations.
 </li>
 <li>
 Review quality control data collected from all production processes and contribute to process improvement.
 </li>
 <li>
 Investigate deviations, out-of-specification (OOS) results, and non-conformities, and implement necessary corrective and preventive actions (CAPA).
 </li>
 <li>
 Ensure process continuity through proper planning and teamwork.
 </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.
 
 
 
 
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Stembio - Hücresel Ürünler - Üretim Personeli / Manufacturing Personnel

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Amerikan Hastanesi

About Company

Stembio - Hücresel Ürünler - Üretim Personeli / Manufacturing Personnel