Engineer II, MS&T

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus features two manufacturing facilities near Baltimore Washington International (BWI) airport and is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 facility is EMA and FDA approved, spanning approximately 200,000 sq. ft. with 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, under development, will add 145,000 sq. ft. with 8 CGMP suites and cold storage. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products, including AAV and other viral vector-based therapies and vaccines.

About the role

We have an opportunity for an Engineer II, MS&T to join our team and support GMP manufacturing operations as a project leader for clinical drug substance and drug product transfers. In this role, you will translate client and process development information into cGMP processes and act as a subject matter expert for biologic upstream and downstream processes. You will work hands-on in a cleanroom and collaborate in a fast-paced, cross-functional environment, making a real impact on delivering advanced therapies to patients in need.

Shift: Monday – Friday, 8am - 5pm
Location: Harmans, MD - BWI (100% onsite)

Responsibilities

• Partner with GMP manufacturing and Process Development teams as MS&T project lead and subject matter expert in areas such as cell culture, purification, and fill & finish processes.
• Serve as team leader for process and product investigations and author investigation reports.
• Lead MS&T technology transfer projects from Catalent Process Development and external clients into GMP manufacturing.
• Author technology transfer documents, Master Production Records, and Standard Operating Procedures to support GMP manufacturing projects.
• Work closely with Program Management to ensure MS&T project milestones are achieved, attending recurring and ad hoc meetings as required.
• Collect and trend process data for client and internal review.
• Assist with training GMP Manufacturing staff on client processes.
• Evaluate and recommend equipment and disposable systems for client projects.
• Perform facility fit assessments, process modeling, and Continued Process Verification statistical analysis.

Requirements

• Bachelor of Science in Chemical Engineering, Chemistry, Biology, Life Sciences, or related field with 3-6 years of experience in the pharmaceutical or biotechnology industry, or Master of Science in these fields with 2+ years of experience.
• Knowledge and expertise relevant to protein and virus manufacturing in a cGMP environment.
• Experience in one or more of the following manufacturing areas: cell and/or microbial culture, protein purification, and fill/finish.
• Experience with process modeling software such as SuperPro, JMP, MatLab, or Aspen is a plus.
• Experience in a Contract Manufacturing Organization environment or similar client-customer based work environment is a plus.
• On-site presence required, as the role involves time on the manufacturing floor and cross-functional collaboration.

Pay

The anticipated salary range for this position in MD is $100,000 – $120,000 plus bonus. The final salary offered may vary based on factors including experience, skills, education, and business needs.

Benefits

• 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.