Engineer I, MS&TPosition SummaryWe 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 CandidateMinimum 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.
PayThe 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 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.
