Process Engineer

Planet Pharma's rapidly growing biotech client is 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.

• 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.

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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.
• 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.

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES

• 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 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