Lead, Manufacturing - Large Scale Purification (Days)

Biogen•Research Triangle Park, NC

1d•$33 - $43

About The Position

The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment. This includes operating process equipment, executing validation protocols, revising cGMP documents, ensuring cGMP compliance, and maintaining equipment and facilities. The role works closely with the shift Supervisor to coordinate critical activities and use resources efficiently, and serves as a preparatory role for the Manufacturing Supervisor position. The position works a 2-2-3 rotating schedule on days, from 6:00 AM to 6:00 PM ET. The factories operate 24/7, and manufacturing teams work 12-hour shifts.

Requirements

Bachelor’s degree from an accredited college or university, preferably in STEM, and at least 4 years of direct experience; or a BioWorks Certificate or associate’s degree, preferably in STEM, and at least 4.5 years of direct experience; or a high school diploma or equivalent and at least 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 and adhere to Good Documentation Practices.
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.

Nice To Haves

Prior purification experience in a leadership capacity.
Lean, Six Sigma, and 5S certifications.

Responsibilities

Execute manufacturing processing steps and support activities, monitoring processes against batch records, SLRs, and control systems; coordinate or lead process steps and serve as an expert for assigned steps.
Coordinate with the Supervisor to schedule shift tasks and allocate resources for production, validation, and project activities.
Share information at shift exchange and ensure issues are communicated appropriately.
Document, record, and review cGMP data, including deviations, according to standard operating procedures; develop or revise documents such as batch records, SLRs, and equipment logbooks; ensure real-time review of BPRs and SLRs is complete.
Participate in training, manage an individual training plan, train associates, share knowledge, observe employee performance, provide timely coaching, and provide feedback to the Supervisor at mid-year and year-end.
Initiate and investigate deviations and develop and implement corrective and preventive actions as required by the Supervisor.
Lead or actively participate in troubleshooting and potentially serve as a subject matter expert for audits.
Serve as the operational point of contact for associates during assigned shifts, providing technical guidance, troubleshooting support, and real-time decision-making.

Benefits

Medical, dental, vision, and life insurance.
Fitness and wellness programs, including fitness reimbursement.
Short- and long-term disability insurance.
At least 15 days of paid vacation and end-of-year shutdown time off from December 26 through December 31.
Up to 12 company-paid holidays and 3 paid days off for Personal Significance.
80 hours of sick time per calendar year.
Paid maternity and parental leave.
401(k) program with company-matched contributions.
Employee stock purchase plan.
Tuition reimbursement up to $10,000 per calendar year.
Employee Resource Groups participation.
Eligible regular employees may receive short- and long-term incentives, including cash bonus and equity incentive opportunities.