Planet Pharma · 3 hours ago
Process Engineer II
Cambridge, MA
Full-time
Onsite
Mid, Senior Level
$90K/yr - $112K/yr
3+ years expPlanet Pharma is a rapidly growing biotech company focused on developing innovative cell therapies to treat ocular diseases. They are seeking a Process Engineer II to provide technical oversight of a late-stage combination cell therapy product, focusing on site readiness, tech transfer, and ongoing process support for clinical and commercial manufacturing.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Valerie Meissner
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
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
Qualification
Required
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
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%
Preferred
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
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase