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.

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.

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