Lead, Manufacturing - Large Scale Purification (Days)

Biogen; North Carolina; On-site; USD 45,000 - 59,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins,

Fitness & Wellness programs

Short- and Long-Term Disability

Vacation and shutdown time off

Paid holidays + personal days

Sick time

Tuition reimbursement

Job summary

Biogen in North Carolina is seeking a Manufacturing Lead who will perform and document daily operations in a cGMP setting, operate process equipment, execute validation protocols, and ensure cGMP compliance while keeping equipment and facilities in good order.

You will coordinate shift tasks with the Supervisor, share information across shifts, review batch records, and support training and coaching of associates, serving as SME for audits and providing real-time troubleshooting.

Qualifications

• Experience leading manufacturing activities and coordinating shift teams in a cGMP environment.
• Ability to follow SOPs and GDP requirements with attention to documentation.
• Experience in aseptic or cleanroom settings and downstream purification operations.
• Knowledge of TrackWise, DeltaV, Syncade or LIMS systems.
• Willingness to train and coach associates and act as SME for audits.

Responsibilities

• Execute manufacturing steps and monitor batch records, coordinating process steps as expert.
• Schedule shift tasks with the Supervisor and allocate resources across production and validation.
• Document and review cGMP data, revise documents, ensure real‑time review of batch records and logs.
• Participate in training, develop individual plans, and coach team members.
• Investigate deviations, implement CAPAs, and lead troubleshooting as SME for audits.
• Serve as operational point of contact during shifts, providing guidance and real-time decisions.

Skills

Leadership

SOP adherence

GDP knowledge

Aseptic environment

Troubleshooting

Education

Bachelor’s degree in STEM

BioWorks certificate / associate degree

High school diploma + 5 yrs experience

Tools

TrackWise

DeltaV

Syncade

LIMS

Job description

About This Role

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 AM – 6:00 PM ET)
• Internal Shift Details: Red Days rotating schedule

The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, revising cGMP documents, ensuring compliance to cGMP, as well as maintaining equipment and facilities. This position works closely with the shift Supervisor to coordinate critical activities collaboratively and utilizes resources efficiently. This is a key preparatory role for the Manufacturing Supervisor position.

What You’ll Do

• Execute manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR, and control system. Coordinates and/or leads process steps as required, serving as a process step(s) expert
• In coordination with Supervisor, schedule tasks for a given shift and plan resource allocation. This includes production, validation, or other project activities. Also, responsible for proper information sharing at shift exchange and ensure all issues are communicated appropriately
• Document, record, and review 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 completeness of BPR/SLR real time review
• Actively participate in training activities, manage your own individual training plan. Provide training to other associates as required and share knowledge with others. Observe performance of employees, provides timely and targeted coaching for employees, and provides feedback to the Supervisor at mid and end of year
• Initiate and investigate deviations, develop and implement corrective and preventative actions as required by supervisor. Lead and/or actively participate in troubleshooting. Serve as possible SME for audits
• Serve as the operational point of contact for associates during assigned shifts, providing technical guidance, troubleshooting support, and real-time decision making

Who You Are

You’re driven by a mission to save lives and bring a deep sense of purpose to the work you do. Biomanufacturing is complex, and you thrive in fast-paced environments where learning agility, problem-solving, and adaptability are essential.

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 work across a shift team, and training associates in a cGMP environment
• Demonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP)
• Experience working in an aseptic or cleanroom environment
• Experience supporting downstream purification manufacturing operations in a cGMP manufacturing environment
• Experience with Trackwise, Delta V, Syncade, LIMS, and/or similar systems
• Previous pipetting experience in a laboratory or manufacturing environment

Preferred Skills

• Prior Purification experience in a leadership capacity
• Lean, Six Sigma and 5S certifications

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.

Benefits

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.