Lead Scientist, QC Program Management

Catalent

2d•Onsite

About The Position

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.

Requirements

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.

Responsibilities

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