Biogen
Lead, Manufacturing - Large Scale Purification (Days)
Research Triangle Park, NC, USA · Senior
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About the role
- Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation.
- Shift Details: This role follows a 2-2-3 calendar rotation on days (6:00 AM - 6:00 PM ET)
- Internal Shift Details: Red Days rotating schedule
Responsibilities
- Document, record, and review cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures.
- Develop and/or revise documents as needed.
- Serve as the operational point of contact for associates during assigned shifts, providing technical guidance, troubleshooting support, and real-time decision making
- Execute manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR, and control system.
Requirements
- Coordinates and/or leads process steps as required, serving as a process step(s) expert
- Provide training to other associates as required and share knowledge with others.
- Initiate and investigate deviations, develop and implement corrective and preventative actions as required by supervisor.
Nice to have
- Preferred Skills
Skills
- The following combination of academic and/or relevant experience may be considered:
- Bachelor's degree from an accredited college or university, STEM preferred and at minimum 4 years of direct experience
- A BioWorks Certificate or associate's degree, STEM preferred and at minimum 4.5 year of direct experience
- A High School Diploma (or equivalent) and at minimum of 5 years of direct experience
- Demonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP)
- Experience working in an aseptic or cleanroom environment
- Experience supporting downstream purification manufacturing operations in a cGMP manufacturing environment
- Experience with Trackwise, Delta V, Syncade, LIMS, and/or similar systems
- Previous pipetting experience in a laboratory or manufacturing environment
- Prior Purification experience in a leadership capacity
- Lean, Six Sigma and 5S certifications
Compensation
- Tuition reimbursement of up to $10,000 per calendar year
- Required Skills for Lead, Manufacturing: $33.17 - $43.27 Pay Range
Benefits
- Medical, Dental, Vision, & Life insurances
- Paid Maternity and Parental Leave benefit
- Biomanufacturing is complex, and you thrive in fast-paced environments where learning agility, problem-solving, and adaptability are essential.
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Employee stock purchase plan
- Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Company info
- We are a global team with a commitment to excellence, and a pioneering spirit.
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 401(k) program participation with company matched contributions
- As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.
This listing is sourced directly from Biogen's careers page and normalized into a canonical job model.