Lead, Manufacturing - Large Scale Purification (Days)

Biogen, Inc.; North Carolina; On-site; USD 46,000 - 60,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life Insurance

Disability insurance

Paid time off

Job summary

Biogen is seeking a Manufacturing Lead to oversee daily cGMP manufacturing operations on a 2-2-3 calendar, days 6:00 AM–6:00 PM ET. You will run and document shift activities, coordinate resources, and partner with the shift Supervisor to ensure timely, compliant production.

You’ll train associates, review deviations, lead troubleshooting, and prepare batch records, SLRs, and equipment logs. Prior experience in aseptic environments and with Trackwise/DeltaV/LIMS is preferred; the role provides

Qualifications

• Bachelor’s degree in STEM with at least 4 years of direct manufacturing experience.
• BioWorks Certificate or associate’s degree with at least 4.5 years of direct experience.
• High School Diploma or equivalent with at least 5 years of direct experience.
• Experience leading manufacturing activities, coordinating shift work, and training associates in a cGMP environment.
• Experience following SOPs and GDP in documentation and operations.
• Experience in aseptic or cleanroom environments; downstream purification familiarity.
• Experience with Trackwise, DeltaV, Syncade, LIMS or similar systems.
• Pipetting experience in a lab/manufacturing setting.

Responsibilities

• Execute manufacturing steps and monitor against batch records, SLRs, and control systems.
• Lead process steps as required and act as a process expert for shift activities.
• Schedule tasks for a shift; plan resources including production and validation.
• Share information at shift exchanges; communicate issues promptly.
• Document, review, and revise cGMP documents and deviations as needed.
• Prepare and revise batch records, SLRs, and equipment logs.
• Ensure real-time review of BPR/SLR; maintain data integrity.
• Participate in training; manage your training plan and coach others.
• Provide coaching during shifts and communicate feedback to the Supervisor.
• Lead or assist in troubleshooting and corrective actions for deviations.
• Serve as SME for audits and as the operational point of contact on shift.

Skills

Leadership

Communication

Problem-solving

Training others

Education

Bachelor’s degree in STEM

BioWorks Certificate / Associate’s degree

High School Diploma + 5 years experience

Tools

Trackwise

Delta V

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

Black 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.


• Coordinate and/or lead process steps as required, serving as a process step(s) expert.


• Coordinate with Supervisor, schedule tasks for a given shift and plan resource allocation, including production, validation, or other project activities.


• Be 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, and provide training to other associates as required and share knowledge with others.


• Observe performance of employees, provide timely and targeted coaching, and provide 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

Pay Range: $33.17 - $43.27

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.

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.

As Biogen recently acquired Apellis, you can find additional open jobs on our Apellis website here.

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.