Lead, Manufacturing (Days)

Biogen•Research Triangle Park, NC

2d•$33 - $43•Onsite

About The Position

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 shift Supervisor to coordinate critical activities collaboratively and utilizes resources efficiently. This is a key preparatory role for the Manufacturing Supervisor position.

Requirements

Bachelor’s degree from an accredited college or university, STEM preferred and at minimum 4 years of direct experience OR A BioWorks Certificate or associate's degree, STEM preferred and at minimum 4.5 year of direct experience OR 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 manufacturing operations and/or buffer preparation processes in a cGMP manufacturing environment.
Experience with Trackwise, Delta V, Syncade, LIMS, and/or similar systems.

Nice To Haves

Prior buffer preparation or downstream experience in a leadership capacity.
Lean, Six Sigma and 5S certifications.

Responsibilities

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.
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 revises 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 Supervisor 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.

Benefits

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
Cash bonus and equity incentive opportunities