Engineer II, 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.

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.

This position offers the chance to make a real impact on delivering advanced therapies to patients in need.

Shift: Monday - Friday, 8am - 5pm

Location:

Harmans, MD - BWI 100% Onsite

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.

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 Super Pro, JMP, Mat Lab, 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.

The anticipated salary range for this position in MD is $100,000 – $120,000 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.

• 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.

Defined career path and annual performance review and feedback…