What are the responsibilities and job description for the Senior Process Engineer – Biologics Technology Transfer position at Chasepro Talent?
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
Salary : $85