Lead, Large-Scale Purification Operations | 12-Hour Shifts

Biogen

North Carolina

On-site

USD 45,000 - 59,000

Full time

14 days+

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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.