Ms&T I

Catalent • Harmans, MD

3d • Onsite

About The Position

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. 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.

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.

Nice To Haves

• 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.

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 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.

Benefits

• Competitive paid time off plus 8 paid holidays.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level