Engineer II, MS&T
Catalent
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Benefits offered by this job
Job summary
Catalent is hiring an Engineer II, MS&T in Harmans, MD to lead GMP manufacturing transfer projects and translate client development info into cGMP processes. You will work hands-on in a cleanroom, collaborating across teams to deliver advanced therapies.
The role requires strong experience in protein/virus manufacturing, cell culture and purification. On-site 8am-5pm, with opportunities to influence pivotal clinical and commercial programs.
Qualifications
- BS in Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 3–6 years of experience in pharma/biotech, or MS with 2+ years.
- Knowledge and expertise relevant to protein and virus manufacturing in a cGMP environment.
- Experience in 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.
- On-site presence required, as the role involves time on the manufacturing floor.
Responsibilities
- Partner with GMP manufacturing and Process Development teams as MS&T project lead and SME in cell culture, purification, and fill & finish.
- Lead MS&T technology transfer projects from Catalent Process Development and external clients into GMP manufacturing.
- Author technology transfer documents, Master Production Records, and SOPs to support GMP projects.
- Collaborate with Program Management to ensure MS&T milestones are met and attend meetings as required.
- Collect and trend process data for client and internal review.
- Assist with training GMP Manufacturing staff on client processes.
- Evaluate equipment and disposable systems for client projects.
- Perform facility fit assessments, process modeling, and CPV statistical analysis.
Skills
Education
Tools
Job description
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 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.
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.
- 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.
Join the global drug development and delivery leader and help us bring over 7,000 life‑saving and life‑enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
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