Sr. Supervisor, Manufacturing (night shift)

Biogen•Research Triangle Park, NC

3d•$95,000 - $124,000

About The Position

This position is on a 12-hour rotation, 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 on our Large Scale Manufacturing Purification Team . 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.

Requirements

Grounded understanding of the operating principles for biologics manufacturing ( Large Scale Purification ).
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
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
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

Nice To Haves

Experience in a GMP pharmaceutical manufacturing facility
Technical/practical experience in Purification Manufacturing
Competency in electronic systems (Oracle, CMMS, Trackwise, etc.)

Responsibilities

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.

Benefits

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