Senior Process Engineer - Biologics Technology Transfer

Senior Process Engineer - Biologics Technology Transfer at Chasepro Talent Senior Process Engineer - Biologics Technology Transfer at Chasepro Talent in Brookline Village, Massachusetts Posted in about 22 hours ago.

Type:

full-time

Job Description:

Job Title - Engineering Project Lead /

Senior Process Engineer Location:

Boston, MA (100% onsite preferred)

Duration:

12 Months Role Summary Hiring a Senior Process Engineer to support biologics drug substance technology transfers across early phase, late phase, and commercial programs. The role involves full process oversight, manufacturing support, documentation, regulatory activities, and raw material control strategy development. This is a fast-paced, cross-functional role requiring strong biologics manufacturing knowledge and the ability to work independently with minimal ramp-up. Key Responsibilities Technology Transfer Support biologics tech transfer activities between development and manufacturing Coordinate timelines, deliverables, and execution readiness Improve transfer processes through SOPs, tools, and training materials Manufacturing Support Review Master Production Records (MPRs) Author/review process descriptions and technical reports Support change controls and deviation investigations Provide floor support during GMP manufacturing Monitor and trend batch performance data Documentation & Regulatory Prepare technical and process documentation Support IND/IMPD and BLA/MAA regulatory submissions Ensure GMP and regulatory compliance Raw Material Control Strategy Develop and support raw material control strategies Conduct risk assessments for alternate materials Justify specifications for regulatory submissions Support material-related regulatory documentation Cross-Functional Collaboration Work closely with: Process Development Manufacturing Operations Quality Assurance Regulatory Affairs External manufacturing partners Required Skills 2-3+ years of biologics industry experience Technology transfer experience Knowledge of upstream/downstream biologics processes GMP manufacturing understanding Technical writing skills Change control and deviation investigation experience Regulatory submission exposure Strong communication and collaboration skills Preferred Skills Hands-on manufacturing floor support experience Raw material control strategy experience Statistical analysis knowledge Continuous improvement/project leadership experience Education BS with 8+ years, OR MS with 6+ years, OR PhD in Engineering or Life Sciences Important Notes Role is not limited to upstream or downstream; requires end-to-end process understanding Fully onsite role with up to 25% travel Candidates must be comfortable supporting GMP manufacturing environments and cross-functional activities