Quality Control Scientist - Microbiology, Bioanalytical

Quality Control Scientist - Microbiology Bioanalytical

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 QC Scientist Microbiology Bio-Analytical and Raw Material is responsible for performing microbiological bio-analytical and raw material testing to ensure the quality and safety of products. The position involves routine testing of raw materials in-process samples and finished products as well as environmental monitoring and support for aseptic control. The QC Scientist will collaborate with cross-functional teams participate in investigations of deviations and non-conformances and contribute to continuous improvement initiatives. This role demands a thorough understanding of regulatory requirements and compliance with standard operating procedures (SOPs). Additionally the QC Scientist will mentor junior staff support audits and ensure proper maintenance and calibration of laboratory equipment playing a key role in upholding the laboratorys operational excellence.

The Quality Control scientist must be able to help the team with Raw material work by being responsible for ensuring the quality and compliance of raw materials used in pharmaceutical manufacturing. This role involves creating material specifications conducting identification tests and performing assays and impurity analyses according to established protocols and regulatory requirements.

The Quality Control Scientist - Microbiology Bioanalytical will report to the Supervisor Quality Control.

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 8:00 am 5:00 pm.

The Role:

• Perform sterility endotoxin microbial identification and compendial testing (e.g. BacT Endotoxin Mycoplasma) on raw materials in-process samples and finished products.
• Conduct EMPQ aseptic control cleaning/disinfection and environmental monitoring of laboratory and manufacturing areas.
• Analyze and trend EM/sterility data prepare monitoring reports and support investigations CAPAs and Change Control for microbiological deviations.
• Collaborate with QA Manufacturing and R&D teams to implement the site Microbial Control Strategy perform growth promotion testing support method development/validation and ensure audit readiness.
• Maintain compliance with SOPs and regulatory requirements (FDA EMA cGMP) by documenting results supporting audits and ensuring equipment calibration and maintenance.
• Support lab operations by maintaining equipment mentoring team members managing supplies and demonstrating strong problem-solving communication and teamwork skills with eagerness to learn and take on new responsibilities.
• Bioanalytical QC: Perform routine and non-routine bio-analytical testing on raw materials in-process samples and finished products using techniques such as ddPCR Flow Cytometry ELISA Viability assays and cell culture; analyze and interpret data to ensure accuracy compliance and assay performance.
• Support QC operations through SOP and documentation management deviation/CAPA investigations Change Controls technology transfer method validation/qualification equipment maintenance and cross-functional collaboration with Manufacturing and Quality Assurance.
• Other duties as assigned

The Candidate:

• BS in Microbiology Biochemistry Analytical Chemistry Molecular Biology or related field with 4 years of relevant experience (MS preferred) or 10 years of relevant experience in lieu of degree.
• Hands-on experience with microbiological testing (sterility endotoxin microbial ID) and assays like BacT Endotoxin and Mycoplasma across raw materials in-process and finished products required.
• Experience in EMPQ cleaning/disinfection aseptic control and environmental monitoring of manufacturing and lab areas a preferred.
• killed in trend analysis of EM and sterility data with experience writing reports and recommending risk-based resolution plans preferred.
• Experience in bioanalytical QC performing routine and non-routine testing on raw materials in-process samples and finished products using techniques such as ddPCR Flow Cytometry ELISA viability assays and cell culture with strong skills in data analysis and ensuring assay accuracy and compliance preferred.
• Experience supporting investigations of deviations or non-conformances supporting CAPAs Change Control and continuous improvement preferred.
• Vision requirements: Must be willing to undergo visual acuity testing including the Graham Field Eye Test from 10 Feet and the Ishihara Charts of Color Deficiency

The anticipated salary range for this position in New Jersey is $81120 $111540 plus annual bonus when eligible. The final salary 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:

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