Lead, Manufacturing

Position Overview

Join to apply for the Lead, Manufacturing role at Biogen. 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 operating process equipment, executing validation protocols, revising cGMP documents, ensuring compliance, and maintaining equipment and facilities. Working closely with the shift Supervisor, you will coordinate critical activities efficiently. This role is a key preparatory step for advancement to a Manufacturing Supervisor position.

Key Responsibilities

• Executes manufacturing processing steps and/or manufacturing support activities, monitoring processes against the batch record, SLR, and control system. Coordinates and/or leads process steps as required, serving as a process step expert.
• In coordination with the Supervisor, schedules tasks for the shift and plans resource allocation, including production, validation, or project activities. Ensures proper information sharing during shift exchange and effective communication of issues.
• Documents, reviews, and records cGMP data and information—including deviations—for processing steps and equipment activities, following standard operating procedures. Develops and revises key documentation such as batch records, SLRs, and equipment logbooks, while ensuring real‑time review completeness.
• Actively participates in training activities, manages an individual training plan, provides training to associates as required, and offers knowledge sharing, performance coaching, and feedback to the Supervisor.
• Initiates and investigates deviations, developing and implementing corrective and preventative actions as directed. Leads or participates in troubleshooting and may serve as a Subject Matter Expert (SME) during audits.

Required Qualifications

• 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

Preferred Qualifications

• 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

Benefits & Perks

• Compensation: 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 bonuses 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 plus 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program with company-matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation