Lead, Manufacturing

About This Role

The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, revising cGMP documents, ensuring compliance to cGMP, as well as maintaining equipment and facilities. This position works closely with shift Supervisor to coordinate critical activities collaboratively and utilizes resources efficiently. This 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.
• Responsible for proper information sharing at shift exchange and ensuring all issues are communicated appropriately.
• Documents, records, and reviews cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures.
• Develops and/or 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, managing individual training plan.
• Provides training to other associates as required and shares knowledge with others.
• Observes performance of employees, provides timely and targeted coaching for employees, and provides feedback to Supervisor mid and end of year.
• Initiates / investigates deviations, develops and implements corrective and preventative actions as required by supervisor.
• Leads and/or actively participates in troubleshooting.
• Serves as possible SME for audits.

• Required:
  
  Bachelor’s Degree in an engineering or scientific discipline preferred + 4 years of direct biomanufacturing experience.
• Required:
  
  Associate degree in an engineering or scientific discipline preferred + 4.5 years of direct biomanufacturing experience.
• Required:
  
  Certificate or HS diploma in an engineering or scientific discipline preferred + 5 years of direct biomanufacturing experience.
• Preferred:
  Prior Purification experience in a leadership capacity.
• Preferred:
  Lean, Six Sigma and 5S certifications.
• Preferred:
  Experience with Trackwise, Delta V, and LIMS in addition to cGMP experience.

Professional

• Base compensation range: $33.17‑$43.27.
• Short‑term and long‑term incentives, including cash bonus and equity incentive opportunities.
• Medical, Dental, Vision, & Life insurances.
• Fitness & Wellness programs including a fitness reimbursement.
• Short‑ and Long‑Term Disability insurance.
• 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.

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.