Title: Principal Scientist – Aseptic Control
Location: Boston, MA (Hybrid – 3 Days Onsite)
Employment Type: Contract (6+ Months)
Status: Accepting Candidates
About the role
Join a Manufacturing Science and Technology team supporting aseptic control strategies for sterile drug product manufacturing. This role focuses on contamination control, microbial strategy development, and cleanroom process oversight supporting biologics and cell and gene therapy manufacturing programs.
The ideal candidate will serve as a technical expert in aseptic processing, partnering with cross-functional teams and external manufacturing partners to ensure sterility assurance and regulatory compliance.
Key Responsibilities
- Provide technical expertise in aseptic processing and microbial control strategies
- Support contamination investigations and environmental monitoring deviations
- Develop and implement risk-based contamination control strategies
- Support facility monitoring programs including environmental monitoring (EM), water, and gases
- Evaluate and optimize disinfectant programs and microbial control procedures
- Support manufacturing investigations and root cause analysis activities
- Collaborate with cross-functional teams including Quality, Regulatory, and Process Development
- Support regulatory submissions and inspection readiness activities
- Provide technical oversight of aseptic filling operations and cleanroom programs
- Partner with internal teams and external manufacturing partners (CMOs/CDMOs)
- Design and implement sterility assurance strategies
- Support microbial testing strategies and filtration validation programs
- Drive continuous improvement initiatives across aseptic manufacturing operations
- Ensure compliance with global regulatory requirements and cGMP standards
Qualifications
- 10+ years of experience in aseptic drug product manufacturing or process development (Required)
- Strong aseptic control and microbiology experience (Required)
- Experience supporting biologics and/or cell and gene therapy (CGT) products
- Strong knowledge of cleanroom operations and microbial control programs
- Experience with environmental monitoring (EM) and contamination control
- Experience supporting manufacturing investigations and root cause analysis
- Strong knowledge of cGMP manufacturing requirements
- Experience supporting sterility assurance programs
- Experience working with CMOs/CDMOs
- Strong technical communication and documentation skills
- Ability to work in fast-paced manufacturing environments
Preferred Qualifications
- Advanced degree (PhD or equivalent) in Microbiology, Biology, or Engineering
- Experience supporting cell and gene therapy (CGT) programs
- Experience supporting aseptic filling operations
- Experience supporting regulatory submissions and inspections
- Experience working in commercial manufacturing environments
- Experience designing facility monitoring programs
- Experience supporting microbial characterization and testing programs
Compensation
- Estimated hourly range: $75–$85/hr (W-2)
- Final rate within this range will be based on skills, experience, and interview results.
- Work Schedule: Hybrid – 3 days onsite weekly