Chasepro Talent · 22 hours ago
Senior Process Engineer
Boston, MA
Contract
Onsite
Senior Level
$80/hr - $89.50/hr
6+ years expChasepro Talent is seeking an experienced Senior Process Engineer to support biologics drug substance technology transfers across early-stage development through commercial manufacturing within CMC. This role involves serving as a technical subject matter expert and collaborating with various teams to ensure successful GMP-compliant manufacturing and process readiness.
Outsourcing/Offshoring
Hiring Manager
Somnath Bhattacharya
Responsibilities
Lead and support biologics drug substance technology transfer activities across development and commercialization
Serve as technical subject matter expert for GMP manufacturing and process validation
Develop and improve tech transfer standards, SOPs, and operational tools
Support regulatory submissions including IND, IMPD, BLA, and MAA
Develop and implement raw material control strategies and specifications
Review technical protocols, manufacturing records, and quality documentation
Monitor manufacturing performance and drive continuous improvement initiatives
Collaborate with cross functional and global manufacturing teams
Qualification
Required
Degree in Engineering or Life Sciences such as Chemical, Biochemical, Mechanical, Biology, or Chemistry
PhD, or MS with 6 or more years, or BS with 8 or more years of relevant experience
Strong experience in biologics or biopharmaceutical manufacturing
Knowledge of GMP manufacturing and process validation
Experience with drug substance unit operations including cell culture, centrifugation, filtration, UF DF, and chromatography
Ability to support manufacturing sites including travel of approximately 25 percent and cleanroom presence
Preferred
Experience establishing raw material control strategies with regulatory agencies
Continuous improvement experience
Basic statistical analysis knowledge
Strong cross functional collaboration and influence skills
Company
Chasepro Talent
Chasepro Talent - your strategic partner in delivering tailored outsourcing solutions that streamline operations and drive business growth.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase