Manufacturing Associate III_

Princeton

**Manufacturing Associate III**

**Summary:**

The **Manufacturing Associate III** is responsible for advising and supporting the overall GMP manufacturing process, through the application of broad knowledge of theories and principles utilized to perform operational, as well as routine tasks in the production of cell therapy and/or human cells cultivation.

**The Role:**

+ Assist with the creation, finalize, and/or approve instructions/forms/protocols related to specific production or generic documentation which could be approved by a supervisor prior to production start.

+ Coordinate and perform daily production scheduling activities in conjunction with MFG Supervisor.

+ Perform and support all manufacturing for both clinical and commercial activities that meet the site’s strategic objectives and is compliant with cGMP’s, safety regulations, and FDA standards.

+ Assist in the training of Manufacturing Associates working in an aseptic environment.

+ Executes production activities that include cell culturing, aseptic processing, cell counts, expansion, separation, and cryopreservation using appropriate techniques and equipment.

+ Identify, develop, and implement process improvements in conjunction with the Manufacturing Supervisor.

+ Coordinates and ensures line clearance is executed prior processing with QA support.

+ Generate and revise internal documents (SOPs, Batch Records, Forms and Protocols)

+ Lead initiations and closures of deviations; serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs.

+ Troubleshoot processing and equipment issues. Work with Facilities and Validation to ensure proper functionality of equipment in conjunction with Manufacturing Supervisor.

+ Work closely with the Manufacturing Supervisor for current and new manufacturing projects. Assist with processes/techniques to meet contract objectives in a timely manner.

+ Lead review and closure of BPR’s ensuring completion is performed in a timely manner.

+ Always follow environmental health and safety (EHS) rules and regulations.

+ Responsible for ensuring all Manufacturing Area logbooks are reviewed regularly for accuracy and completeness in conjunction with the Manufacturing Supervisor.

+ Hands on experienced in the operation of the following: Cell Counters, Cell separation machines, Electroporation Machines, Centrifuges, Incubators, Controlled Rate Freezers, Liquid Nitrogen Storage Tanks is preferred.

+ Perform cleaning/disinfection of the manufacturing classified areas as needed per area procedure.

+ Responsible to oversee and ensure all equipment is calibrated, validated, and qualified as required.

+ Additional duties as assigned.

**The Candidate:**

+ Highly experienced in working with Biologics and/or Cell Therapy (i.e., CAR-T, CRISPR, etc.…).

+ Prior experience working in a clean room environment (Grade A, B, C and D)

+ 4 to 6 years of experience in biopharmaceutical based GMP manufacturing operations/Cell Therapy/Human Cell Cultivation.

+ CDMO experience highly preferred.

+ Excels in situations while working under pressure meeting timelines.

+ Highly effective communication skills both verbally and written. Proficiency in English (verbal and written) is required.

+ Able to work in clean room environment with aseptic gowning for long periods of time.

+ Strong aseptic technique and good documentation practices is essential.

+ Flexibility with work schedule – accommodate changes in the schedule including working on other shifts as per operational needs (1st, 2nd or 3rd shift, holidays and weekends) as required.

+ Ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence.

+ Act as a team lead in the absence of a supervisor.

+ High School Diploma with a minimum of 4-6 years of GMP Manufacturing experience. OR

+ Associate degree in a scientific, engineering or biotechnology discipline with a minimum of 4 years related experience; coursework with biotechnology focus highly desirable. OR

+ Bachelor’s Degree (BS/BA) from an accredited college or university with an emphasis in a scientific or engineering discipline and a minimum of 3-year relevant experience.

+ Solid knowledge and understanding of FDA regulations and GMP systems.

+ Highly experienced in Cell Culture, Cell counts, Cell expansion (incubators), Cell Washing, Cell Separation, Cryopreservation, and aseptic manipulations in a Biosafety Cabinet (BSC) is highly preferred.

+ Highly experienced in aseptic manipulations is a must.

+ Highly experienced in human cells cultivation required.

+ SME (subject matter expert) in technical knowledge of bioreactors, incubators, controlled rate freezers, cryopreservation, disposable single use technology, cell selection/depletion/separation, electroporation, centrifugation, and aseptic processing.

**P** **osition Benefits:**

+ 152 hours PTO & 8 Holidays

+ Medical, Dental & Vision Benefits and 401k

+ Tuition Reimbursement

**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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (atalent.com/us/en) 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 [email protected] . 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 & 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— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (atalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .