Lead, Manufacturing

Job Description

This position follows a traditional 2-2-3 shift from 6 a.m. to 6 p.m. (RED Day Shift). It is a key preparatory role for the Manufacturing Supervisor position.

The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment, including operating process equipment, executing validation protocols, revising cGMP documents, ensuring compliance, and maintaining equipment and facilities. The role works closely with the shift Supervisor to coordinate critical activities collaboratively and utilizes resources efficiently.

• Execute manufacturing processing steps and/or support activities, monitoring the process against batch records, SLRs, and the control system. Coordinate and lead process steps as required, serving as a process step expert.
• Coordinate with the Supervisor to schedule tasks for each shift and plan resource allocation, including production, validation, or other project activities. Ensure proper information sharing during shift exchanges and communicate all issues appropriately.
• Document and review cGMP data and information, including deviation documentation, following standard operating procedures. Develop and revise documents as needed. Key documentation includes batch records, SLRs, and equipment logbooks, ensuring real‑time review completeness.
• Participate actively in training activities, manage personal training plans, and provide training to other associates as required. Observe employee performance, provide timely coaching, and deliver feedback to the Supervisor mid‑year and at year‑end.
• Initiate and investigate deviations, develop and implement corrective and preventative actions as required. Lead or actively participate in troubleshooting and serve as a potential SME for audits.

You are an agile self‑starter who takes accountability, learns quickly in a dynamic environment, and prioritizes accurate and ethical data record‑keeping. You are an expert in multiple unit operations with strong technical knowledge of processes and equipment, and you have skill in leading, scheduling tasks, training, and supporting teammates. Soft skills we value include teamwork, conflict‑resolution interpersonal skills, teachability, patience, and adherence to procedures.

• Bachelor’s Degree in an engineering or scientific discipline plus 4 years of direct biomanufacturing experience.
• Associate degree in an engineering or scientific discipline plus 4.5 years of direct biomanufacturing experience.
• Certificate or high school diploma in an engineering or scientific discipline plus 5 years of direct biomanufacturing experience.

• Prior purification experience in a leadership capacity.
• Lean, Six Sigma, and 5S certifications.
• Experience with Trackwise, Delta V, and LIMS in addition to cGMP experience.

Job Level: Professional

Base compensation range: $33.17‑$43.27 per hour.

Base salary is determined by an analytical approach that incorporates relevant skills & experience, location, and internal equity.

Regular employees are eligible for short‑term and long‑term incentives, including cash bonuses and equity opportunities, designed to reward recent achievements and future potential.

• Medical, Dental, Vision, and Life insurance.
• Fitness & Wellness programs with fitness reimbursement.
• Short‑ and Long‑Term Disability insurance.
• Minimum 15 days of paid vacation and additional end‑of‑year shutdown time off (Dec 26‑Dec 31).
• Up to 12 company‑paid holidays plus 3 paid personal significance days.
• 80 hours of sick time per calendar year.
• Paid maternity and parental leave benefit.
• 401(k) program with company matching.
• Employee stock purchase plan.
• Tuition reimbursement up to $10,000 per calendar year.
• Employee Resource Groups participation.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by federal, state or local law. Biogen is an E‑Verify Employer in the United States.