Sr. Supervisor, Manufacturing (Night shift)

Biogen; North Carolina; Vor Ort; USD 98.000 - 127.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Dental insurance

Vision insurance

Life insurance

Fitness reimbursement

Disability insurance

Paid vacation

Year-end shutdown time off

Zusammenfassung

Biogen in North Carolina is seeking a Sr. Supervisor to oversee night-shift manufacturing of clinical and commercial parenteral products under GMP. You will supervise Manufacturing Associates, schedule tasks, ensure compliance, draft and review documents, and coordinate with QA, QC, facilities, and other groups.

The role requires a strong foundation in parenteral filling, GMP, safety, and leading teams. Bachelor’s STEM or equivalent with several years of transferrable experience; 12-hour night

Qualifikationen

• Bachelor’s Degree (STEM strongly preferred), or equivalent transferrable experience.
• Associates’ Degree with 6 years transferrable experience or High School with 8 years transferrable experience.
• Experience in a GMP pharmaceutical manufacturing facility and leading/mentoring staff.

Aufgaben

• Supervises Manufacturing Associates on night shift, guiding and developing staff.
• Ensures manufacturing activities follow cGMPs; confirms staff trained prior to activity.
• Schedules daily manufacturing activities and communicates changes to staff and management.
• Coordinates with QA, QC, materials, facilities, and other groups to ensure proper execution of batch records, sampling and validation.
• Reviews batch-related documents and ensures proper cGMP documentation practices.
• Trains associates on process activities, safety, and cGMP requirements; reviews safety records.
• Oversees validation activities and coordinates with facilities on maintenance and changeovers.
• Drafts and revises batch-related documents and SOPs.

Kenntnisse

Leadership

Organization

Accountability

Tactical

GMP experience

Ausbildung

Bachelor's Degree (STEM strongly preferred)

Associates' Degree

High School Diploma

Tools

Oracle

CMMS

Trackwise

Jobbeschreibung

About This Role

This position is on a 12-hour rotation, Red Night shift on a 2, 2, 3 scheduleThis 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

Job Level: 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 (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

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 an