Manufacturing Associate III
Manufacturing Associate III
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Job Description
Manufacturing Associate III
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.
Our U.S. commercial cell therapy manufacturing facility is located in Princeton NJ and is part of Catalents cell therapy network including our European Center of Excellence for cell therapy inGosselies Belgium.
The CGMP manufacturing facility is equipped with 16 flexible clean rooms QC labs and warehouse space to support late-stage and commercial-scale autologous and allogeneic cell therapy production.
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 Manufacturing Associate III will report to the Manager Manufacturing.
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.
This is a full- time salaried position: Monday Friday 7:00 am 3:30 pm.
The Role:
- Perform and support clinical and commercial manufacturing activities including cell culture aseptic processing cell counts expansion separation and cryopreservation in compliance with cGMP FDA and safety regulations.
- Develop finalize and review production-related documentation (SOPs batch records forms and protocols) and ensure manufacturing logbooks are accurate and up to date.
- Coordinate daily production scheduling line clearance and documentation activities with Manufacturing Supervisors and QA.
- Train and mentor Manufacturing Associates on aseptic techniques processes and compliance expectations.
- Lead or support investigations deviations CAPAs and batch record reviews/closures to ensure timely resolution and regulatory compliance.
- Collaborate with Manufacturing Supervisors on new and ongoing projects ensuring processes and techniques meet operational and contract objectives.
- Troubleshoot manufacturing processes and equipment issues partnering with Facilities and Validation to maintain proper functionality.
- Serve as a subject matter expert (SME) on bioreactors incubators controlled rate freezers cryopreservation disposable single-use technology cell selection/depletion/separation electroporation centrifugation and aseptic processing; oversee equipment calibration validation and qualification.
- Maintain facility and cleanroom standards including cleaning/disinfection of classified areas and strict adherence to environmental health and safety (EHS) regulations.
- Identify develop and implement process improvements to enhance operational efficiency product quality and compliance.
- Additional duties as assigned.
The Candidate:
- High school diploma with at least 4 years of GMP manufacturing experience (associate degree preferred) OR bachelors degree in a scientific or engineering discipline with a minimum of 3 years of GMP manufacturing experience.
- Extensive experience in cell culture cell counts cell expansion (incubators) cell washing cell separation cryopreservation and aseptic manipulations in a Biosafety Cabinet (BSC) preferred; strong aseptic technique and good documentation practices required.
- Experience working in cleanroom environments (Grade A B C and D) with the ability to perform tasks while fully gowned in aseptic attire for extended periods required.
- Experience working with Biologics and/or Cell Therapy required; experience with CAR-T and CRISPR preferred.
- Experience in biopharmaceutical GMP manufacturing operations cell therapy or human cell cultivation required.
- Hands-on experience operating cell counters cell separation machines electroporation machines centrifuges incubators controlled rate freezers and liquid nitrogen storage tanks preferred.
- Excellent verbal and written communication skills in English including strong technical writing problem-solving and organizational abilities with the capacity to work under pressure and meet deadlines required.
- Flexibility to work across shifts (1st 2nd 3rd) including holidays and weekends as required by business needs.
- Must meet physical requirements including computer/equipment use accurate documentation ability to lift/push up to 50 lbs. work in tight spaces handle sporicidal agents/cleaning solutions and perform ceiling-to-floor cleaning.
- Vision and environmental requirements include willingness to undergo visual acuity testing (Graham Field Eye Test from 10 feet and Ishihara Charts of Color Deficiency) and the ability to work in controlled cleanroom environments (Grade BD) with full gowning and aseptic techniques; occasional exposure to moving mechanical parts biohazards (including human blood components) and risk of electrical shock.
The anticipated hourly rate for this position in New Jersey is $38.46 - $50.96 plus overtime pay and annual bonus when eligible. The final hourly rate offered to a successful candidate may vary and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job type and length of experience within the industry skillset education business needs etc. Catalent is a multi-state employer and this salary range may not reflect positions that work in other states.
Why you should Join Catalent:
- Defined career path and annual performance review and feedback process.
- Diverse inclusive culture.
- Potential for career growth on an expanding team.
- Cross-functional exposure to other areas within the organization.
- 152 hours of paid time off annually 8 paid holidays.
- Medical dental vision and 401K benefits effective day one of employment.
- Tuition Reimbursement.
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 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 . 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 for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Required Experience:
IC
Employment Type
Full-Time
