Sr. Supervisor, Manufacturing

Kappaalphapsi1911; North Carolina; On-site; USD 95,000 - 124,000; Full time

Job summary

A leading biotechnology company seeks a Sr. Supervisor for manufacturing operations on a rotating schedule. The role involves supervising associates, ensuring GMP compliance, training staff, and coordinating across departments. Candidates should have a relevant degree and substantial experience in biologics manufacturing with strong leadership and organizational skills.

Benefits

Medical, Dental, Vision, & Life insurances

Fitness & Wellness programs including a fitness reimbursement

Short- and Long-Term Disability insurance

Paid vacation and additional end-of-year shutdown time off

Paid Maternity and Parental Leave

401(k) program participation with company match

Tuition reimbursement of up to $10,000 per year

Qualifications

• Grounded understanding of operating principles for biologics manufacturing.
• Solid knowledge of engineering/scientific principles associated with designated areas.
• Knowledge on safety, GMP, and Human Performance principles.

Responsibilities

• Supervises Manufacturing Associates and schedules shift tasks.
• Ensures GMP compliance and safety, drafts and reviews manufacturing documents.
• Troubleshoots operational and equipment problems.

Skills

Leadership

Accountability

Organization

Tactical

Education

Bachelor's Degree in a relevant scientific or engineering discipline

Associate's Degree with a minimum of 8 years relevant experience

High school diploma with a minimum of 10 years relevant experience

Tools

Oracle

CMMS

Trackwise

Job description

Sr. Supervisor

This position is on a 12-hour rotation, Day 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; 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. Provides on the floor support with manufacturing associate(s).

* Performs manufacturing activities per cGMP, 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

You have a grounded understanding of the operating principles for biologics manufacturing, and a solid knowledge of the engineering and scientific principles associated with designated areas of responsibility. You understand the primary design principles for the facility (e.g., air pressure differentials, material flow, people flow, utility systems) and a knowledge of the roles of other functional groups within the company. You are particularly knowledgeable on safety, GMP, and Human Performance principles, andcan influence through effective communication of vision and purpose.

Qualifications

• Bachelor's Degree (preferred in a relevant scientific or engineering discipline) with 6 years of relevant experience,
• Associate's Degree with a minimum of 8 years relevant experience,
• High school diploma with a minimum of 10 years relevant experience
• Experience working in biologics manufacturing
• 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

Preferred Skills

• Technical/practical Parenteral Filling (Component Prep, Filling, etc.) experience
• * Competency in electronic systems (Oracle, CMMS, Trackwise, etc.)

Additional Information

The base salary range for this position is$95,000- $124,000 annually

Base salary offered is determined though 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 days off for Personal Significance

*80 hours of sick timeper 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

Job Level: Professional

Additional Information

The base compensation range for this role is: $95,000.00-$108,000.00

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 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 onto learn more about our DE&I efforts.

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.

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