MS&T Engineer II – Biologic Process Transfer

Catalent; Harmans (MD); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

Career development opportunities

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

Cell culture

Protein purification

Fill/finish

Process development

cGMP environment

Process modeling

Education

Bachelor of Science in Chemical Engineering

Master of Science in Chemical Engineering

Tools

SuperPro

JMP

MatLab

Aspen

Job description

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.