MS&T I

Engineer I, MS&T 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.

Summary We have an opportunity for an Engineer I, MS&T to join our team and support GMP manufacturing operations as a project leader for the transfer and startup of clinical drug substance and drug product. You will help translate client and Process Development information into cGMP processes. This role requires hands-on work in a cleanroom and collaboration in a fast-paced, cross-functional environment. The Engineer I, MS&T will report to the Manager, MS&T. Shift: Monday – Friday, 8am - 5pm Location: Harmans, MD - BWI 100% Onsite The Role 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 tech transfer projects from Catalent Process Development and external clients into GMP manufacturing. Author tech 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 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. Other duties as assigned. The Candidate Minimum Requirements Bachelor of Science in Chemical Engineering, Chemistry, Biology, Life Sciences, or related field with 2+ years of experience in the pharmaceutical or biotechnology industry, or Master of Science in these fields with 1+ years of experience. Knowledge and expertise in protein and virus manufacturing in a cGMP environment. Experience in one or more manufacturing areas: cell and/or microbial culture, protein purification, and fill/finish. On-site presence required, as the role involves time on the manufacturing floor and cross-functional collaboration. Preferred Skills & Background 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-focused work setting is a plus. Pay The anticipated salary range for this position in MD is $80,000 – $90,000 Plus Bonus. 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 Defined career path and annual performance review and feedback process. Diverse, inclusive culture. Potential for career growth on an expanding team within an organization