About This Role
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. 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 biologics 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 Purification Manufacturing
- Competency in electronic systems (Oracle, CMMS, Trackwise, etc.)
Required Skills
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
Additional Information
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 on to 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.
Top Skills
What We Do
Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases.
Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics.
With approximately 7000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.
