Senior Specialist, QA Batch Disposition

Job Title: Senior Specialist, QA Batch Disposition

Location: Harmans, Maryland

Company: Catalent Inc.

About Us: 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.

Catalent is committed to a Patient First culture through excellence in quality and compliance, ensuring the safety of every patient, consumer, and Catalent employee.

About Our Facility: 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.

Position Overview: The Senior Specialist, QA Batch Disposition supports GMP documentation for master/working cell banks, bulk drug substances, and finished drug products. 

Position Schedule: This is a full-time, salaried position that requires 100% on-site presence. The hours are Monday to Friday, 9:00AM - 6:00PM

Key Responsibilities:

• 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.

• Interacts with the quality team and internal stakeholders to support the development, manufacturing, testing, packaging, and release of cell and gene therapy products.

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

• 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.

• Other duties as assigned.

The Candidate:

• Masters’ degree with a minimum of 2 years' experience in biologic, biopharmaceutical, or regulated industry. Scientific or Life Science discipline degree preferred

• Bachelors’ degree with a minimum of 4 years' experience in biologic, biopharmaceutical, or regulated industry. Scientific or Life Science discipline degree preferred

• Proficient knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.

• Proficient with biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish.

• Ability to quickly learn new and novel manufacturing processes supporting new clients.

Compensation: The anticipated salary range for this position in Maryland is $93,280 - $128,260 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:

• 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 matc