Lead, Manufacturing - Cell Culture (Nights) (Research Triangle Park, NC)

This job is with Biogen, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation.

• Shift Details: This role follows a 2-2-3 calendar rotation on days (6:00 PM - 6:00 AM ET)
• Internal Shift Details: Red Nights rotating schedule

 

About This Role

The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment, including operation of process equipment, execution of validation protocols, and revision of cGMP documents while ensuring compliance to cGMP and maintenance of equipment and facilities. This position works closely with the Shift Manager to coordinate critical activities collaboratively and utilize resources efficiently. This is a key preparatory role for the Manufacturing Shift Manager position.

 

The Manufacturing Lead responsibilities include but are not limited to:

• Execute cell culture manufacturing processing steps and/or manufacturing support activities while monitoring performance against the batch record, electronic systems, and process controls. Serve as a Subject Matter Expert (SME) for multiple upstream unit operations and lead critical process activities.
• Coordinate shift activities in partnership with the Shift Manager, including production execution, validation activities, and project support. Plan resources effectively and ensure thorough communication during shift changes.
• Document, record, and verify cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures. Develop and/or revise documents as needed. Key documentation includes batch records, SLRs, and equipment logbooks. Ensure real-time review requirements are met.
• Train, mentor, and support Manufacturing Associates while managing personal training requirements. Observe performance of employees, provide timely and targeted coaching for employees, and share feedback with the Shift Manager at mid-year and year-end.
• Initiate and actively participate in deviations investigations, develop and implement corrective and preventative actions as required. Lead and/or actively participate in troubleshooting. Serves as possible potential SME for audits and tours.

 

Who You Are

Our Cell Culture Manufacturing team is looking for an agile, self-motivated leader who thrives in a fast-paced manufacturing environment. You take ownership of your work, act with integrity, and are committed to maintaining the highest standards of safety, quality, and compliance. You bring strong technical expertise in upstream manufacturing processes while supporting the development of others through coaching, training, and collaboration. Success in this role requires excellent communication skills, attention to detail, sound decision making, and the ability to lead by example working across teams and shifts.

 

Required Skills for Lead, Manufacturing: $33.17 - $43.27 Pay Range

• The following combination of academic and/or relevant experience may be considered:
  • Bachelor's degree from an accredited college or university, STEM preferred and at minimum 4 years of direct experience
  • A BioWorks Certificate or associate's degree, STEM preferred and at minimum 4.5 year of direct experience
  • A High School Diploma (or equivalent) and at minimum of 5 years of direct experience
• Demonstrated experience leading manufacturing activities, coordinating shift work, and training associates in a cGMP environment
• Demonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP)
• Experience supporting Upstream cell culture manufacturing operations in a pharmaceutical, biotechnology, or related regulated manufacturing environment
• Experience working in an aseptic or cleanroom environment
• Experience with manufacturing systems such as Trackwise, Delta V, Syncade, LIMS, or similar systems

 

Preferred Skills

• Prior cell culture manufacturing experience in a leadership capacity
• Experience with bioreactor operations, Media Preparation, Harvest operations, Aseptic Cell Expansion, and other upstream manufacturing processes

 

Job Level: Professional

Additional Information

The base compensation range for this role is: $33.17-$43.27

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 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.