Engineer II, MS&TAbout SiteOur 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.
Position SummaryWe 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
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 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.
The CandidateMinimum 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.
PayThe 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.
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 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.
