Sr. Manufacturing Specialist I
Biogen
August 18, 2026
On-site
Triangle, NC
Operations
Shift/Work Schedule
- Monday–Friday, 8 AM–5 PM (site-based; infrequent off-hours support may be required).
Responsibilities
- Primary receiving-site operational readiness lead for new product/process technology transfers.
- Develop, maintain, and drive integrated site readiness plans; run readiness reviews/governance, action tracking, and stakeholder communications.
- Identify readiness gaps; escalate barriers impacting manufacturing startup/operations.
- Coordinate readiness activities: Change Controls, Material Readiness, Equipment Qualification Support, Manufacturing Documentation Readiness, Training Readiness, Floor Support Planning, Analytical Readiness, Changeover Readiness.
- Lead complex cross-functional projects (timelines, risks, stakeholder expectations) for technology transfer and manufacturing improvements/execution.
- Author/maintain manufacturing documentation (procedures, work instructions, logbooks, batch records, solution lot records, investigations, technical reports) with high accuracy/compliance.
- Initiate/own complex manufacturing-focused Change Controls, CAPAs, Planned Exceptions, continuous improvement initiatives.
- Support investigations/deviations and perform root cause analyses; implement corrective/preventive actions.
- Provide technical guidance as SME for processes/equipment during execution.
Qualifications & Required Skills
- Bachelor’s degree (or direct experience in lieu).
- 3+ years in biotech/pharma/adjacent field; cGMP knowledge.
- Strong root-cause/problem-solving; trend investigation and corrective action.
- Experience authoring/reviewing/maintaining technical documentation and manufacturing records.
- Intermediate–advanced Microsoft Office and computer-based quality systems.
- Continuous Improvement/Operational/Process Excellence experience.
Preferred Skills
- Lean and/or Six Sigma experience.
- PMP certification or formal project management training.
Benefits (if selected by employer)
- Medical, dental, vision & life insurance; paid vacation (min 15 days) plus end-of-year shutdown; holidays; sick time; paid maternity/parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement (up to $10,000/year).
- Monday–Friday, 8 AM–5 PM (site-based; infrequent off-hours support may be required).
Responsibilities
- Primary receiving-site operational readiness lead for new product/process technology transfers.
- Develop, maintain, and drive integrated site readiness plans; run readiness reviews/governance, action tracking, and stakeholder communications.
- Identify readiness gaps; escalate barriers impacting manufacturing startup/operations.
- Coordinate readiness activities: Change Controls, Material Readiness, Equipment Qualification Support, Manufacturing Documentation Readiness, Training Readiness, Floor Support Planning, Analytical Readiness, Changeover Readiness.
- Lead complex cross-functional projects (timelines, risks, stakeholder expectations) for technology transfer and manufacturing improvements/execution.
- Author/maintain manufacturing documentation (procedures, work instructions, logbooks, batch records, solution lot records, investigations, technical reports) with high accuracy/compliance.
- Initiate/own complex manufacturing-focused Change Controls, CAPAs, Planned Exceptions, continuous improvement initiatives.
- Support investigations/deviations and perform root cause analyses; implement corrective/preventive actions.
- Provide technical guidance as SME for processes/equipment during execution.
Qualifications & Required Skills
- Bachelor’s degree (or direct experience in lieu).
- 3+ years in biotech/pharma/adjacent field; cGMP knowledge.
- Strong root-cause/problem-solving; trend investigation and corrective action.
- Experience authoring/reviewing/maintaining technical documentation and manufacturing records.
- Intermediate–advanced Microsoft Office and computer-based quality systems.
- Continuous Improvement/Operational/Process Excellence experience.
Preferred Skills
- Lean and/or Six Sigma experience.
- PMP certification or formal project management training.
Benefits (if selected by employer)
- Medical, dental, vision & life insurance; paid vacation (min 15 days) plus end-of-year shutdown; holidays; sick time; paid maternity/parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement (up to $10,000/year).