Lead Scientist, QC Program Management

Lead Scientist, QC Program Management

Position Summary:

• Work Schedule: Monday – Friday, 8am – 5pm.  
• 100% on-site

Catalent is a leading global CDMO partnering with pharma and biotech innovators to accelerate development and delivery of life-changing therapies. Our FDA-licensed, state-of-the-art CGMP gene therapy campus in Harmans, MD—just minutes from BWI Airport—features EMA and FDA-approved manufacturing suites, fill/finish capabilities, labs, and warehousing to support Phase 3 through commercial production of advanced therapies, including AAV and other viral vector-based products.

The Lead Scientist, QC Program Management will serve as the liaison between Quality Control (QC) and clients. The Lead Scientist, QC Program Management will work with Project Management and clients to establish testing in the Quality Control lab, and external contract testing laboratories.

The Lead Scientist, QC Program Management will report to the Manager, QC Program Management.

The Role

• Attend and lead client, internal project, and outsourced testing laboratory meetings to establish and maintain testing requirements and timelines.
• Serve as the primary QC point of contact, ensuring completion of all project‑assigned QC activities.
• Coordinate internal testing and testing schedules with the Quality Control group aligned to manufacturing plans.
• Onboard clients at project kickoff and partner with cross‑functional teams (PM, PD, AD, QC, QA) to ensure method readiness for GMP runs.
• Coordinate with outsourced testing labs and clients to transfer methods, manage testing execution, and track QC deliverables.
• Partner with QC sample management, stability, and critical reagent teams to manage inventories, shipments, stability studies, and ad hoc requests.
• Review and approve client sampling plans, batch records, product specifications, and related documentation to ensure accurate sample collection and testing schedules.
• Develop, maintain, and monitor a QC client activities tracker to ensure on‑time execution and visibility.
• Effectively communicate QC‑related updates, results, and issue resolution to clients and internal stakeholders.
• Demonstrate flexibility to support unique campaign requirements, including off‑hour or weekend work, and actively participate in training to remain current in ComplianceWire.
• Other duties as assigned by management

The Candidate

• Bachelor’s degree in Biology, Chemistry, Engineering, Pharmacy, Information Technology or related discipline and a minimum of 8 years of experience working in a QC environment (will consider reduced experience with increased levels of education in same field)
• Project Management and Contract Manufacturing experience necessary.
• Comprehensive and practical working knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP and EP, and other applicable regulatory guidance (US and EU).
• Demonstrated ability to prioritize and multitask with strong responsiveness, attention to detail, sound judgment, and effective problem‑solving skills in both quality and business contexts.
• Excellent written and verbal communication skills with professionalism and patience to collaborate cross‑functionally at all levels and effectively engage with external clients.
• Strong analytical skills with the ability to evaluate information and resolve Quality Control–related issues using scientific and regulatory principles.
• Proficient in Microsoft Office tools (Excel, Word, PowerPoint) and project management platforms such as Microsoft Project and Smartsheet.

The anticipated salary range for this position in Maryland is $118,720 to $163,240 plus an 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

• Potential for career growth within an expanding team.
• Defined career path and annual performance review & feedback process.
• Cross-functional exposure to other areas within the organization.
• Medical, Dental, Vision, and 401K are all offered from day one of employment.
• 152 hours of PTO and 8 paid holidays.
• Opportunity to work on Continuous Improvement Processes

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 DisabilityAccommodations@catalent.com. 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 spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.