Sr. Supervisor, Manufacturing (Night shift)

Biogen, Inc.; Northern (KY); Hybrid; USD 98,000 - 127,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k) plan with match

Tuition reimbursement

Job summary

Biogen is seeking a Night Shift Senior Supervisor to oversee manufacturing of clinical and commercial parenteral products under GMP conditions.

You will supervise Manufacturing Associates on a 12-hour rotation, draft and review batch documentation, and coordinate with multiple departments to ensure compliant, timely production. Strong leadership and GMP knowledge are required.

Qualifications

• Supervises Manufacturing Associates on night shift in GMP manufacturing.
• Identifies development gaps and implements plans/objectives.
• Experience in GMP pharmaceutical manufacturing and safety focus.

Responsibilities

• Supervises Manufacturing Associates – guiding, coaching and developing staff.
• Schedules daily manufacturing activities and communicates changes to staff and management.
• Coordinates with QC, materials, manufacturing sciences, validation and QA for PPRs, sampling and validation.

Skills

Leadership

GMP

Parenteral Filling

Safety

Communication

Education

Bachelor’s Degree (STEM preferred)

Associates’ Degree + 6 years

High School Diploma + 8 years

Tools

Oracle

CMMS

TrackWise

Job description

About This Role

This 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 Are

• Grounded 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 Skills

• Sr. 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

JobLevel: Professional

Additional Information

The 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 (Dec26-Dec31)
  • 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

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission.

Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.

Read on to learn more about our Biogen.

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.