Process Engineer I, MSAT/ExM
About The Position
Aurion Biotech is a rapidly growing biotech focused on developing innovative cell therapies to treat ocular diseases. We are looking for a Process Engineer I, 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. If you are a highly motivated and experienced GMP manufacturing professional with a passion for developing and commercializing innovative drug therapies, we encourage you to apply for this exciting opportunity to join our team.
Requirements
- B.S, M.S, or Ph.D. degree in a scientific or engineering discipline required.
- B.S. with 3-5 years or M.S. with 0-2 years of experience in MS&T, External Manufacturing or Process Development for biologics/cell therapies.
- 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 apply scientific and engineering principles to complex technical problems and data trending with minimal input.
- 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%.
Nice To Haves
- Experience with tech transfers, scale-up, and validation of cell therapy or other biologics processes preferred.
- 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.
Responsibilities
- 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.
- Support creation of key technical documents, including tech transfer plans, batch records, risk assessments, deviation analyses, and change controls.
- Provide input on process support playbooks and troubleshooting guides.
- Support 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.
- Support monitoring of Drug Substance and Drug Product performance metrics and recommend improvements in process consistency, yield, or compliance.
- Other duties as assigned.
Benefits
- Robust Benefits : We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
- Total Rewards: We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work.
- Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Ph.D. or professional degree
Number of Employees
51-100 employees
