Lead, Manufacturing

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This position follows a traditional 2-2-3 format from 6p-6a (Night Shift).

The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment, including operation of process equipment, execution of validation protocols, revision of cGMP documents, ensuring compliance, and maintaining equipment and facilities. This position works closely with the shift Supervisor to coordinate critical activities collaboratively and utilizes resources efficiently. It is a key preparatory role for the Manufacturing Supervisor position.

• Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR, and control system. Coordinates and/or leads process steps as required, serving as a process step(s) expert.
• In coordination with Supervisor, schedules tasks for a given shift and plans resource allocation, including production, validation, or other project activities. Shares proper information at shift exchange and ensures all issues are communicated appropriately.
• Documents, reviews, and records cGMP data and information (including documentation of deviations) for processing steps and equipment activities, following standard operating procedures. Develops and revises documents as needed. Key documentation includes batch records, SLRs, and equipment logbooks. Ensures completeness of BPR/SLR real‑time review.
• Actively participates in training activities, manages individual training plan, provides training to other associates as required, and shares knowledge with others. Observes employee performance, provides timely and targeted coaching, and gives feedback to Supervisor at mid‑year and year‑end.
• Initiates and investigates deviations, develops and implements corrective and preventative actions as required by Supervisor. Leads and/or participates in troubleshooting and serves as possible SME for audits.

Our Large Scale Manufacturing Cell Culture team is looking for an agile self‑starter who takes accountability, is willing to learn quickly in a dynamic environment, and prioritizes accurate and ethical data record‑keeping. The incumbent is expected to be an expert on multiple unit operations, possess excellent technical understanding of the processes and equipment, and be skilled at leading, scheduling tasks, training, and supporting other associates.

We prioritize possession of soft skills such as teamwork, interpersonal and conflict‑resolution skills, teachability, patience, and willingness to follow procedures.

• Bachelor’s Degree in an engineering or scientific discipline preferred + 4 years of direct biomanufacturing experience
• Associate degree in an engineering or scientific discipline preferred + 4.5 years of direct biomanufacturing experience
• Certificate or HS diploma in an engineering or scientific discipline preferred + 5 years of direct biomanufacturing experience

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

The base compensation range for this role is: $32.69–$42.31 per hour. Regular employees are eligible for short‑term and long‑term incentives, including cash bonus and equity opportunities, based on performance.

• Medical, Dental, Vision, & Life insurances
• 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)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

We are a global team with a commitment to excellence and a pioneering spirit. Our mid‑sized biotechnology company offers stability, resources, and opportunities for learning, growth, and expanding your skills. Our mission is to deliver life‑changing medicines. We are committed to building an inclusive culture that values diverse backgrounds, perspectives, and experiences.

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.