Qureos Mentor

Catalent Pharma Solutions

<div>Process Engineer
Position Summary:
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
The Boston-area facility is Catalent&rsquo;s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.
Catalent Pharma Solutions is Chelsea, MA is hiring a Process Engineer who is responsible for assisting senior engineering staff in the design and implementation of manufacturing processes, instrumentation and equipment for clinical and commercial manufacturing. This individual assists in engineering design and process scale-up under the guidance of senior engineering staff. She or he establishes operating equipment specifications and improves manufacturing techniques. The Process Engineer is involved in new product scale-up, process optimization, technology transfer and process validation activities.
This is a full-time on site salaried position. The core hours are Monday &ndash; Friday 8:00AM &ndash; 4:30PM EST
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Role
<ul><li>Participates in the design, specification and installation of pharmaceutical manufacturing equipment;</li><li>
Participates in technology transfer and scale up activities;</li><li>
Provides plant floor support to manufacturing operations and personnel;</li><li>
Supports manufacturing and engineering operations by participating in the following: Draft and maintain Standard Operating Procedures and Batch Records, Production support, Process/equipment troubleshooting, Training of operators;</li><li>
Supports technical aspects of equipment/process investigations;</li><li>
Supports interdepartmental teams to facilitate product technology transfer from pilot plant to clinical manufacturing;</li><li>
Participates in manufacturing operations in problem solving with regards to equipment and systems;</li><li>
All other duties as assigned;</li></ul>
The Candidate<ul><li>
Bachelor&rsquo;s degree in Chemical Engineering (preferred), Mechanical Engineering, Pharmaceutical Sciences or related field required</li><li>
A minimum of 1+ years of relevant experience required</li><li>
Experience working in a FDA regulated operation, preferably in the pharmaceutical/biotechnology area</li><li>
Knowledge of Good Manufacturing Practice requirements required</li><li>
Demonstrated knowledge of equipment/process operating and design competencies preferred</li><li>
Strong process and mechanical hands-on capabilities required</li><li>
Ability to lead manufacturing operations during production runs</li><li>
Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;</li></ul>
Why you should join Catalent:<ul><li>
Defined career path and annual performance review and feedback process</li><li>
Diverse, inclusive culture</li><li>
Positive working environment focusing on continually improving processes to remain innovative</li><li>
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives</li><li>
152 Hours + 8 paid holidays</li><li>
Several Employee Resource Groups focusing on D&amp;I</li><li>
Dynamic, fast-paced work environment</li><li>
Community engagement and green initiatives</li><li>
Generous 401K match</li><li>
Company match on donations to organizations</li><li>
Medical, dental and vision benefits effective day one of employment</li><li>
Tuition Reimbursement &ndash; Let us help you finish your degree or start a new degree!</li><li>
WellHub program to promote overall physical wellness</li><li>
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories</li></ul>
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. 
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written &amp; signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond&mdash; it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.</div>

Job Id: SeTGOVbxKxtC22LUeGxv59ofHXNiUiRIr5ScMyZEt/OkKd8LJDm3QUINKvAPvakeamcJVwM+BjunpmtKRTDwJkggn39IXz/feulazr4xi4Oi8cRw2HnfIat9QZ4kaZkLoGNkddkEHi1meTZ3M3NP6F+xHZiikP8eV5wM92bGFrzLZQqUhts9ka+/xlkDgFAXXIRixFPCGQ==

Process Engineer

<div>Label Designer
Position Summary
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
This 206,878 square-foot facility, located in the Philadelphia area is Catalent&rsquo;s global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID&trade; safe storage labels for your studies. Single panel and Peel-ID&trade; safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.
Catalent Pharma Solutions in Philadelphia is hiring a Label Designer. Label Designer prepare, coordinate, design and generate Clinical Study Labels and Commercial Labels. Prepare, coordinate, upload and generate Randomization Codes for use in clinical studies. Perform the above functions using the Electronic Labeling System (PMX or Clinicopia). Verify all information conforms to GMP, Annex 13, Customer and Catalent regulatory requirements
This is a full-time role position: Monday-Friday: 8:00am-4:30pm shift. Hourly, Onsite
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Role<ul><li>
Works closely with Project Management and the customer for the identification and interpretation of a customer&rsquo;s clinical labeling requirements ensuring label text for accuracy and compliance with clinical study and regulatory requirements as well as ensuring accurate timelines and labeling requirements</li><li>
Generates randomization codes using appropriate labeling system and uploads and verifies randomization codes using appropriate labeling system</li><li>
Generates multilingual text labels using appropriate labeling system and regulatory references</li><li>
Coordinates with Label Control Associate printing requirements for designed labels</li><li>
Review and interpret clinical study protocol to better determine label requirements</li><li>
Determine use of label stock design and specification based on client, material label is being applied to and product storage requirements</li><li>
Manage label stock inventory based on client label specification requirements</li><li>
Design label stock needed for label design study requirements</li><li>
All other duties as assigned;</li></ul>
The Candidate<ul><li>
Works closely with Project Management and the customer for the identification and interpretation of a customer&rsquo;s clinical labelling requirements ensuring label text for accuracy and compliance with clinical study and regulatory requirements as well as ensuring accurate timelines and labelling requirements</li><li>
Generates randomization codes using appropriate labelling system and uploads and verifies randomization codes using appropriate labelling system</li><li>
Generates multilingual text labels using appropriate labelling system and regulatory references</li><li>
Coordinates with Label Control Associate printing requirements for designed labels</li><li>
Review and interpret clinical study protocol to better determine label requirements</li><li>
Determine use of label stock design and specification based on client, material label is being applied to and product storage requirements</li><li>
Manage label stock inventory based on client label specification requirements</li><li>
Design label stock needed for label design study requirements</li><li>
Individual may be required to sit, stand, walk regularly and occasionally lift up to 50 pounds</li></ul>
Why you should join Catalent:<ul><li>
Defined career path and annual performance review and feedback process</li><li>
Diverse, inclusive culture</li><li>
Positive working environment focusing on continually improving processes to remain innovative</li><li>
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives</li><li>
152 hours of PTO + 8 paid holidays</li><li>
Several Employee Resource Groups focusing on D&amp;I</li><li>
Dynamic, fast-paced work environment</li><li>
Community engagement and green initiatives</li><li>
Generous 401K match</li><li>
Medical, dental and vision benefits</li><li>
Tuition Reimbursement - Let us help you finish your degree or start a new degree!</li><li>
WellHub- program to promote overall physical wellness</li><li>
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories</li></ul>
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. 
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written &amp; signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond&mdash; it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.</div>

Job Id: hdmhePiJ0fBgcuMDSn78c4IUA45ZnqIFfX3sLU39Sy1uayUpDVP+X7WriresYcOPO9JpQpQA6Z8z40JP7/f1cvIsV11mXV0Pujy95jps34rVzSwGtdoT0cQwrtPq4W1JZkVnhUAelSsJu5c8YaD9vhgo6XFSBhLLNj170mx96iHwpOKQjnDYCmUnliZMp2CdXZj3e6E=

Label Designer

<div>Label Associate
Position Summary
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
This 206,878 square-foot facility, located in the Philadelphia area is Catalent&rsquo;s global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID&trade; safe storage labels for your studies. Single panel and Peel-ID&trade; safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.
Catalent Pharma Solutions in Philadelphia is hiring a Label Associate. The Label Associate is responsible for the creation, preparation, control and destruction of primary and secondary packaging labels utilized in the packaging and distribution of stability, analytical, commercial, and clinical trial material. In addition, Label Control is responsible for the generation, issuance and control of Randomization Codes.
This is a full-time role position: Monday-Friday: 8:00am-4:30pm shift. Hourly, Onsite
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Role<ul><li>
This position is responsible for the ordering, receipt, preparation, staging, return, storage and destruction of labels</li><li>
Receive English, foreign text, booklet, multi-panel (e.g. 2 part-2 panel, 2 part-3 panel), Case Report Form [CRF], open-label and randomized labels into the inventory system</li><li>
Adhere to labeling project timelines to ensure required materials are ready within the agreed upon timeframe. Responsible for creating all label inspection packets prior to the arrival/printing of all labels (English, foreign text, booklet, multi-panel, CRF, open-label and randomized)</li><li>
Responsible for formatting all randomization codes prior to printing/receipt of all clinical labels. Ensure compliance to GMPs, SOPs, and FDA rules and regulations</li><li>
Interact with Quality Assurance and Label Coordinators ensuring label inspections completed within timeline requirements</li><li>
Assist with staging labels for use in production. Assist in rectifying label problems and reporting outcomes to Project Management</li><li>
Assist in managing label stock utilized in internal printing via Inventory Adjustments through JD Edwards by performing inventory reports/resolution of all blank stock</li><li>
All other duties as assigned;</li></ul>
The Candidate<ul><li>
Required a High School Diploma or Equivalent. Bachelor&rsquo;s Degree preferred</li><li>
Clinical supplies label experience preferred</li><li>
Knowledge and experience with cGMP and FDA regulations preferred</li><li>
Working knowledge of Microsoft Outlook, Word, Excel, Internet Explorer required</li><li>
Ability to work well with people of diverse cultures preferred</li><li>
Individual may be required to sit, stand, walk regularly and occasionally lift up to 50 pounds</li></ul>
Why you should join Catalent:<ul><li>
Defined career path and annual performance review and feedback process</li><li>
Diverse, inclusive culture</li><li>
Positive working environment focusing on continually improving processes to remain innovative</li><li>
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives</li><li>
152 hours of PTO + 8 paid holidays</li><li>
Several Employee Resource Groups focusing on D&amp;I</li><li>
Dynamic, fast-paced work environment</li><li>
Community engagement and green initiatives</li><li>
Generous 401K match</li><li>
Medical, dental and vision benefits</li><li>
Tuition Reimbursement - Let us help you finish your degree or start a new degree!</li><li>
WellHub- program to promote overall physical wellness</li><li>
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories</li></ul>
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. 
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written &amp; signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond&mdash; it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.</div>

Job Id: e+BBVO3VHKUGH9CLAGYZzkDKHug3lsFGvRF5NP+QVK8gH/HhaOEOt6BaichZzXLEgPPiwcBkOoK002dwbslqWuMIG5+a+2+vKd8sByf+6NHQkp9XF74QZfeakIPzZjSBTo9qRP0zGt7rH1GZOBvSA2vhp4cHJhQjZXK7Q9mtioBHu4YmsMjDcGuIr0C0htaO2JyUlmKq

Label Associate

<div>Global Procurement Category Facilities, Maintenance and Engineering
Position Summary
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
The Procurement Director &ndash; Facilities, Maintenance &amp; Engineering is responsible for developing and executing sourcing strategies that optimize cost, quality, and efficiency across facility operations. The Procurement Director &ndash; Facilities, Maintenance &amp; Engineering will drive supplier relationships, ensure compliance with procurement policies, and support business objectives through effective vendor management and contract negotiations. A key focus is aligning procurement initiatives with corporate strategy while ensuring operational excellence at the site level.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
The Role
Strategic Procurement &amp; Stakeholder Engagement:<ul><li>
Partner closely with internal stakeholders and leadership to develop and implement IFM and Facilities, Maintenance and Engineering procurement strategies that align with business needs.</li><li>
Understand business requirements, supplier capabilities, and market trends to build a strategic procurement portfolio and sourcing roadmap.</li><li>
Identify and prioritize cost savings, cash flow optimization, operational efficiencies, and value-creation opportunities.</li><li>
Deploy best-in-class procurement tools, methodologies, and digital solutions to drive operational efficiency and procurement effectiveness.</li></ul>
IFM Implementation &amp; Supplier Performance Management:<ul><li>
Ensure IFM programs are successfully implemented at the site level by establishing robust governance, performance metrics (KPIs), and financial commitments from vendors.</li><li>
Act as a strategic business partner by challenging specifications where needed and advocating for standardization and cost-effective solutions.</li><li>
Lead supplier negotiations to secure optimal terms, drive cost savings, and maximize value for the organization.</li><li>
Drive compliance with Procurement Policies and Procedures across all IFM and Facilities-related sourcing activities.</li></ul>
Market Analysis &amp; Category Management:<ul><li>
Conduct market intelligence research to assess supply availability, competitive dynamics, and future price trends within the IFM and Facilities category.</li><li>
Develop and execute category strategies that support long-term business growth while mitigating risks.</li><li>
Select and manage suppliers based on best-in-class criteria, ensuring the consistent delivery of high-quality products and services.</li><li>
Develop strong partnerships with strategic vendors through a structured Supplier Relationship Management (SRM) program.</li></ul>
Risk Management &amp; Technology Utilization:<ul><li>
Assess supply chain risks and develop proactive mitigation strategies to ensure business continuity.</li><li>
Leverage E-Procurement tools and stay informed on emerging technologies to enhance procurement capabilities.</li><li>
Monitor vendor and product performance, ensuring compliance with contractual obligations, quality standards, and service-level agreements (SLAs).</li><li>
Ensure all procurement activities adhere to ethical standards, avoiding any actual or potential conflicts of interest.</li><li>
Other duties as assigned.</li></ul>
The Candidate<ul><li>
Bachelor&rsquo;s degree in Business, Finance, Operations, Supply Chain or comparable disciplines. Masters preferred, Industry certifications a plus.</li><li>
Minimum of 10 years of progressive experience in procurement and best-in-class practices, principles, process, tools and methodologies.</li><li>
Demonstrates the successful development and implementation of sourcing strategies and clear knowledge and understanding of supply market, industry, and category dynamics.</li><li>
A successful track record leading and managing complex negotiations.</li><li>
Demonstrates strong business judgment and critical thinking to create and evaluate innovative options and uses a fact-based decision-making process to develop and implement strategies that will drive positive results and deliver value.</li><li>
Possesses a strong working knowledge and experience in key procurement areas including: IFM implementation, Cost Modeling/TCO, Legal and Contract law, New product development and sourcing and Expertise in successfully executing Supplier Management programs.</li><li>
Direct knowledge of Enterprise Resources Planning software and procurement systems and their functionality, along with strong analytical skills including financial management and metrics.</li><li>
Travel will be required: 20-30%.</li><li>
Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.</li></ul>
Why You Should Join Catalent<ul><li>
Defined career path and annual performance review and feedback process</li><li>
Diverse, inclusive culture</li><li>
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives</li><li>
Dynamic, fast-paced work environment.</li><li>
Community engagement and green initiatives</li><li>
Generous 401K match and Paid Time Off accrual</li><li>
Medical, dental and vision benefits effective day one of employment</li><li>
Tuition Reimbursement</li></ul>
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. 
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written &amp; signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond&mdash; it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.</div>

Job Id: Ni2hQtwc64h6Iz0U0Dx4Nuvk/4dM5oshgro/zoamNPMizRE4AC8c+D+fMsZBPwdK8iqkFmWQKW41DXFYezpdCjW6aZCrM/gTYlllGjHsGuc3q3kGNMsGRRcQbZNnFrP9FCmMVfTiUbSQqXYR9z8ScwMsPUdJBmEl86fYDH/4UWFZzmE8Xlykzo6iA4l4jcGm7TKukaRZ61L/uIHzAXPUR9UfIM53gzE05rMbUksVIgqk2ea7nMV20jfJodD9jS+PKW2XliUfN4ln

Global Procurement Category Facilities, Maintenance and Engineering

<div>Clinical Production Specialist
Position Summary
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
This 206,878 square-foot facility, located in the Philadelphia area is Catalent&rsquo;s global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID&trade; safe storage labels for your studies. Single panel and Peel-ID&trade; safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.
Catalent Pharma Solutions in Philadelphia is hiring a Clinical Production Specialist. Assigned to and responsible for the overall execution, training, monitoring and supervising clinical production staff within a specific clinical packaging batch record operation. Responsible for safety, quality, production rates, material reconciliation, BRNRFT, and timelines adherence in the specific production batch record operation assigned to. This position requires a general knowledge of clinical applications regarding randomization schedules, open label, blind labeling, study collation and treatment groups. Department assignments cover multiple look-alike blister card packaging, over-encapsulation, bottle filling, pouching operations, clinical labeling, kit assembly, collating and distribution
This is a full-time role position: Monday-Friday: 7:45am - 4:15pm. 1st shift. Hourly, Onsite
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Role<ul><li>
Monitors, organizes and performs all functions associated with packaging of clinical trial supplies and assures compliance to GMPs, SOPs, FDA, DEA and OSHA rules and regulations in the specific production batch record assigned to</li><li>
Oversees specific batch record operations assigned to which includes both primary and secondary production rooms equipped with various pharmaceutical packaging equipment including but not limited to: automated bottle line, form, fill and seal equipment, card sealing, vial and ampoule labelers, pouch equipment and medical device tray sealing</li><li>
Responsible for production involving manual and automated application of randomized labels on bottles, cards, cartons, kits, vials, syringes and ampoules</li><li>
Responsible for insuring correct placement of multiple look-alike product combinations in blister units, cards and bottles</li><li>
Responsible for maintaining and ordering personnel, safety, disposable and support packaging supplies for specific assigned production room operation</li><li>
Responsible for entering data accurately in batch records and logbooks</li><li>
Must review completed manufacturing and packaging batch records in a timely manner</li><li>
All other duties as assigned;</li></ul>
The Candidate<ul><li>
Required a High School Diploma or Equivalent.</li><li>
Associates Degree Highly preferred</li><li>
One+ years Clinical, contract or production experience preferred</li><li>
Working knowledge of Microsoft Outlook, Word, Excel, Internet Explorer required</li><li>
 JD Edwards experience or similar ERP systems highly desired</li><li>
 Working knowledge of cGMPs, DEA and OSHA rules and regulations preferred</li><li>
 Demonstrate ability to train and oversee production personnel during production operation execution highly desired</li><li>
Knowledge of packaging equipment in a Just-in-Time environment nice to have.</li><li>
Individual may be required to sit, stand, walk regularly and occasionally lift up to 50 pounds</li></ul>
Why you should join Catalent:<ul><li>
Defined career path and annual performance review and feedback process</li><li>
Diverse, inclusive culture</li><li>
Positive working environment focusing on continually improving processes to remain innovative</li><li>
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives</li><li>
152 hours of PTO + 8 paid holidays</li><li>
Several Employee Resource Groups focusing on D&amp;I</li><li>
Dynamic, fast-paced work environment</li><li>
Community engagement and green initiatives</li><li>
Generous 401K match</li><li>
Medical, dental and vision benefits</li><li>
Tuition Reimbursement - Let us help you finish your degree or start a new degree!</li><li>
WellHub- program to promote overall physical wellness</li><li>
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories</li></ul>
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. 
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written &amp; signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond&mdash; it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.</div>

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Clinical Production Specialist

Join Catalent Pharma Solutions and explore 5 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.