Process Engineer II, MSAT​/ExM

Process Engineer II, MS&T/ExM

Location:

Cambridge, MA (Hybrid)

Reports To:

Director, Manufacturing

Salary Range: $112,000 to $123,000

Aurion Biotech is a rapidly growing biotech focused on developing innovative cell therapies to treat ocular diseases. We are looking for a Process Engineer II, MS&T/ExM to provide technical oversight of a late-stage combination cell therapy product, focusing on leading site readiness, new cleanroom expansions, tech transfer, risk assessments, submission of regulatory documents, comparability/validation campaigns, and ongoing process support to enable late-stage clinical and commercial manufacturing.

• Support tech transfer activities and GMP operations for late-stage clinical and commercial programs, including PIP support and CDMO collaboration.
• Participate in new site/suite readiness activities, including risk assessments, tech transfer strategy, planning, and execution of feasibility and engineering runs.
• Support GMP manufacturing execution, including on-site presence during initial campaign activities, troubleshooting issues, and driving investigations to closure.
• Develop and maintain strong relationships with internal stakeholders and external partners and ensure strong collaboration and productivity to deliver successful late phase, scale-up cGMP clinical and commercial batches.
• Support authoring and review of CMC sections of health authority submissions. Provide immediate response support, as required.
• Own or support creation of key technical documents, including tech transfer plans, batch records, risk assessments, deviation analyses, and change controls.
• Create process support playbooks and troubleshooting guides.
• Drive deviation and change-control impact assessments, ensuring robust root-cause analysis and timely closure of GMP investigations.
• Collaborate with manufacturing sites to ensure technology, equipment, and documentation are in place to support compliant and efficient manufacturing.
• Contribute to validation activities (e.g., PPQ campaign, process characterization, etc).
• Support manufacture data capture for trending and CPV.
• Perform hands-on training in Process Development labs including maintaining cell lines.
• Ensure cross-functional alignment with Process Development, Process Sciences, Manufacturing Validations, Quality, Regulatory, and Supply Chain to execute tech transfers and implement process improvements.
• Monitor Drug Substance and Drug Product performance metrics and recommend improvements in process consistency, yield, or compliance.
• Other duties as assigned.

• B.S, M.S, or Ph.D. degree in a scientific or engineering discipline required.
• B.S. with 5-7 years or M.S. with 3-5 years of experience in MS&T, External Manufacturing or Process Development for biologics/cell therapies.
• Experience with tech transfers, scale-up, and validation of cell therapy or other biologics processes preferred.
• Experience with leadership or project management preferred but not required.
• Familiarity with the development and implementation of manufacturing improvement strategies (lean principles) for cell therapies is a plus.
• Knowledge of late-stage and BLA-enabling activities a plus.
• Experience with late-stage clinical and/or commercial cell therapy manufacturing a plus.

• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.
• Familiarity with working with GMP manufacturing facilities or CDMOs during tech transfer and/or cGMP manufacturing.
• Strong analytical and problem-solving skills, with the ability to independently apply scientific and engineering principles to complex technical problems and data trending.
• Understanding of cGMP regulations and requirements for manufacturing cell therapies or other biologics.
• Proficiency in authoring and reviewing protocols and reports that support GMP manufacturing and regulatory filings.
• Ability to meet deadlines, adapt to rapid changes, and work in a fast-paced team environment.
• Proficient use of MS Office products, JMP or other data analysis software.
• Travel required up to 40%.

• Robust Benefits: full health insurance and family coverage, 401(k) matching, EAP, FSA, generous PTO.
• Total Rewards: competitive compensation packages.
• Perks and Fun: paid parking, commuter passes, in-office lunches, team events, community projects.