About This RoleThis position is on a 12-hour rotation, Red Night shift on a 2, 2, 3 schedule
This position is responsible for the supervision of manufacturing of clinical and commercial products under GMP conditions. The incumbent will supervise Manufacturing Associates on a Night shift; schedules shift tasks; ensures GMP compliance and safety; drafts and reviews manufacturing documents; troubleshoots; and coordinates with other departments.
What You'll Do- Supervises Manufacturing Associates - observing/instructing, coaching, leading and developing staff. Identifies technical/non-technical development gaps and implements applicable plans/objectives.
- Performs manufacturing activities per cGMPs, ensuring that reports are fully trained on a given activity prior to performing the activity.
- Schedules and directs daily manufacturing activities, timely communicating scheduling changes/issues to staff and management.
- Coordinates manufacturing activities with other departments. This includes providing updates to production schedulers, and working closely with quality control, materials management, manufacturing sciences, validation, facilities, process engineering, and quality assurance, etc. to ensure execution of PPRs, sampling, validation, etc.
- Reviews and approves batch related documents, ensuring the proper cGMP documentation practices are followed.
- Trains manufacturing associates on process activities, including Safety requirements and cGMP requirements. Reviews safety records and identifies/implements corrective measures.
- Supervises validation activities, ensuring proper and timely execution of validation protocols required in respective areas.
- Troubleshoots operational and equipment problems and makes recommendations. Also coordinates emergency repairs, changeovers, and preventative maintenance activities with the facilities group.
- Coordinates and drafts revisions of batch related documents, including batch records and SOPs.
Who You AreGrounded understanding of the operating principles for Parenteral Filling and Drug Product Manufacturing. Solid knowledge of the engineering and scientific principles associated with designated areas of responsibility. Understands the primary design principles for the facility (e.g., air pressure differentials, material flow, people flow, utility systems). Basic understanding of the roles of other functional groups within the company. Particularly knowledgeable on safety, GMP, and Human Performance principles. Can influence through effective communication of vision and purpose
Required Skills & Behaviors - Leadership (champions the correct behaviors, values driven, sets & maintains culture)
- Organization (maintaining a supportive work environment, team-development)
- Accountability (consistency, clear understanding of roles, responsibilities, expectations)
- Tactical (can allocate resources effectively depending on tasks at hand, according to incoming and outgoing batches/campaigns
- Experience in a GMP pharmaceutical manufacturing facility
Preferred Skills - Technical/practical experience in Drug Product/Parenteral Filling
- Competency in electronic systems (Oracle, CMMS, Trackwise, etc.)
Required SkillsSr. Supervisor- Bachelor's Degree (STEM strongly preferred) + 4 years of transferrable experience.
- Associates' Degree + 6 years of transferrable experience
- High School Diploma (or equivalent certificate) + 8 years of transferrable experience
Job Level: Professional
Additional InformationThe base compensation range for this role is: $98,000.00-$127,000.00
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.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
