Senior QC Scientist - Program Management

Catalent Pharma Solutions; Glen Burnie (MD); On-site; USD 110,000 - 120,000; Full time

Benefits offered by this job

Medical/Dental/Vision

Tuition Reimbursement

Paid Time Off

8 Holidays

Job summary

Catalent Pharma Solutions seeks a Senior QC Scientist - Program Management to coordinate testing workflows and serve as the primary QC liaison with clients and internal teams onsite in Harmans, MD. The role emphasizes maintaining testing timelines, regulatory compliance, and strong cross‑functional collaboration.

The position demands 4–8 years in QC, GMP/ICH knowledge, and excellent communication. Onsite work with potential off-hours to support campaigns and deadlines.

Qualifications

• Bachelor’s degree in a life sciences or related field with 4–8 years in QC.

Responsibilities

• Serve as the primary QC liaison for clients and internal teams, aligning testing requirements, deliverables, and timelines.
• 2: Coordinate QC activities across Project Management, Process Development, Analytical Development, QC, and QA for GMP readiness.
• 3: Manage internal and external testing execution, including method transfers and outsourced testing.
• 4: Oversee sample management, reagents, shipments, and logistics.
• 5: Establish and coordinate stability programs with clients and internal teams.
• 6: Generate and maintain sampling plans and testing schedules.
• 7: Develop project trackers to monitor QC milestones and progress.
• 8: Align manufacturing schedules with QC testing activities for timely reporting.
• 9: Communicate QC updates and results to clients and stakeholders.

Skills

GMP knowledge

Cross-functional collab

Project coordination

Communication skills

Analytical thinking

Regulatory understanding

Education

Bachelor’s degree in Biology/ Chemistry/ Engineering/ Pharmacy/ IT

Tools

MS Office Suite

Microsoft Project

Smartsheet

Job description

Senior QC Scientist - Program Management

About Site

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities, is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies.

The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse.

The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing.

Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

Position Summary

We have an opportunity for a Senior QC Scientist - Program Management to join our team. This role serves as the key liaison between Quality Control and clients, ensuring testing requirements are met across internal and external laboratories. The position involves close collaboration with Project Management and other internal teams to establish and maintain testing processes. The successful candidate will play a vital role in coordinating activities, maintaining timelines, and ensuring quality standards are upheld.

Shift: Monday – Friday, 8am – 5pm.
Location: Harmans, MD - BWI
100% Onsite

The Role

• Serve as the primary Quality Control (QC) liaison for clients, internal project teams, and outsourced testing laboratories, ensuring alignment on testing requirements, deliverables, and timelines.
• Coordinate QC activities across Project Management, Process Development, Analytical Development, Quality Control, and Quality Assurance to support GMP manufacturing readiness.
• Manage internal and external testing execution, including method transfers, outsourced testing support, and deliverable tracking.
• Partner with QC sample management and critical reagent teams to oversee sample, reagent, and material inventories, shipments, and logistics.
• Establish and coordinate stability programs with clients and internal stability teams.
• Generate, review, and maintain client sampling plans, ensuring accurate sample collection and testing schedules.
• Develop and maintain project trackers, monitoring QC milestones, deliverables, and testing progress for assigned clients.
• Align manufacturing schedules with QC testing activities to ensure timely testing and reporting.
• Communicate QC-related updates, testing results, and project status effectively to clients and internal stakeholders.
• Support a flexible, compliance-focused environment through participation in training, adherence to campaign-specific requirements, and availability for occasional off‑hour or weekend activities.
• Perform other duties as assigned by management.

The Candidate

Minimum Requirements

• Bachelor’s degree in Biology, Chemistry, Engineering, Pharmacy, Information Technology, or a related discipline, and 4–8 years of experience working in a Quality Control environment (reduced experience may be considered with higher education in the same field).
• Strong working knowledge of GMP regulations, ICH guidelines, FDA requirements, USP/EP standards, and other applicable U.S. and EU regulatory expectations.
• Proven ability to manage multiple priorities in a fast‑paced environment, demonstrating strong organizational skills, responsiveness, sound judgment, and attention to detail.
• Excellent written and verbal communication skills with the ability to effectively collaborate across cross‑functional teams, leadership, and external clients.
• Strong analytical and problem‑solving capabilities with the ability to assess complex Quality Control issues and drive effective resolutions.
• Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint), Microsoft Project, and Smartsheet.
• Demonstrated ability to apply scientific, quality, and regulatory principles to support operational, compliance, and Quality Control activities.
• Highly detail‑oriented with a commitment to accuracy, follow‑through, and continuous improvement.

Preferred Skills & Background

• Project Management and Contract Manufacturing experience.

Pay

The anticipated salary range for this position in MD is $110,000 – $120,000 plus bonus. The final salary offered to a successful candidate may vary and will depend on several factors, including but not limited to the type and length of experience within the job, type and length of experience within the industry, skillset, education, and business needs. 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 within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision 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 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.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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.

Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.