Lead, Large-Scale Purification Manufacturing

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

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