This role serves as a pivotal Subject Matter Expert leading technical investigations and driving process improvements for clinical and commercial manufacturing campaigns
Job Summary
This role serves as a pivotal Subject Matter Expert leading technical investigations and driving process improvements for clinical and commercial manufacturing campaigns.
The successful candidate will interface directly with regulatory agencies during inspections and present technical reports on operational activities.
Biogen offers a comprehensive benefits package including up to $10,000 in tuition reimbursement, equity incentives, and paid parental leave.
Matching Summary
This role serves as a pivotal Subject Matter Expert leading technical investigations and driving process improvements for clinical and commercial manufacturing campaigns.
Salary
Base: $151,000.00-$208,000.00; Bonus/Equity: Short-term cash bonus and equity incentive opportunities available; Benefits: Medical, dental, vision, life insurance, 401(k) match, and tuition reimbursement up to $10,000
Skills & Requirements
Must-have
Parenteral filling operations expertise
Visual inspection and packaging knowledge
cGMP and FDA/EMA regulatory compliance
Process Performance Qualification requirements
Cross-functional project management skills
Nice-to-have
Six Sigma Black Belt Certification
Experience with regulatory inspections
Strong data analysis capabilities
Training program development experience
Global change control implementation
Key Requirements
Bachelor's degree + 10 years experience OR Master's + 8 years OR PhD + 6 years
In-depth knowledge of Parenteral Filling Operations
Ability to work independently in cross-functional groups