Batch Record Reviewer I

We're hiring Batch Record Reviewers to provide documentation support for all pharmaceutical manufacturing activities in Baltimore, Maryland.

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 Batch Record Reviewer I is responsible for providing support to GMP documentation of master/working cell banks, bulk drug substance, and finished drug product. In this role, the individual is responsible for continuously monitoring systems and procedures to ensure compliance with applicable regulatory and industry standards, and to identify areas of opportunity and quality improvements. 

This is a full-time, salaried position and is 100% site based. The schedule is a rotating 7:00AM – 7:00PM schedule (2 days on, 2 days off, 3 days on rotation.)

Catalent’s FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus in Baltimore, Maryland. The campus, featuring two manufacturing facilities, supports Phase 3 through commercial manufacturing of advanced therapeutic products, including Adeno-associated Virus (AAV), and other viral vector-based therapies and vaccines.

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

• Review documentation for manufacturing activities associated with commercial, development, and engineering execution in accordance with good documentation practices (GDP), including but not limited to executed batch records, master batch records, product labels, SMPs, and product specific documents.

• Independently executes batch record review for completeness, accuracy and cGMP compliance.

• Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product.

• Critically review various documentation types to ensure completeness, accuracy and compliance including but not limited to test methods, method validation protocols and reports and SOPs.

• Compile and report performance metrics for Batch Review and Release.

• Support on-the-floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.

• Other duties, as assigned.

The Candidate

• Bachelor’s degree with a minimum of 2 years’ experience in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field.)

• Bachelor’s degree in Life Science preferred.

• Associate’s degree or High School Diploma with a minimum of 4 years’ experience in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field.)

• Prior experience with the documentation of GMP processes.

• Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines.

The anticipated salary range for this position in Maryland is $73,000 to $94,000 plus an annual bonus. 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

• Medical, dental, vision, and wellness benefits are effective on the first day of employment.

• Potential for career growth on an expanding team and organization.

• 152 hours of paid time off annually plus 8 paid holidays.

• Community engagement and green initiatives.

• Engaging D&I Employee Resource Groups.

• Tuition reimbursement program.

• Generous 401K match.

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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 [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.