Lead, Manufacturing

Biogen•Research Triangle Park, NC

3d•Onsite

About The Position

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 in an engineering or scientific discipline preferred + 4 years of direct biomanufacturing experience
Associate degree in an engineering or scientific discipline preferred + 4.5 years of direct biomanufacturing experience
Certificate or HS diploma in an engineering or scientific discipline preferred + 5 years of direct biomanufacturing experience
Teamwork
Interpersonal skills for conflict resolution
Teachability
Patience
Willingness to follow procedures

Nice To Haves

Prior Purification experience in a leadership capacity
Lean, Six Sigma and 5S certifications
Experience with Trackwise, Delta V, and LIMS in addition to cGMP experience.

Responsibilities

Executes 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, schedules 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.
Documents/records and reviews cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures.
Develops and/or revises documents as needed. Key documentation includes batch records, SLRs, and equipment logbooks.
Ensure completeness of BPR/SLR real time review.
Actively participates in training activities, managing their own individual training plan.
Provides training to other associates as required and shares knowledge with others.
Observes performance of employees, provides timely and targeted coaching for employees, and provides feedback to Supervisor mid and end of year.
Initiates / investigates deviations, develops and implements corrective and preventative actions as required by supervisor.
Leads and/or actively participates in troubleshooting.
Serves as possible SME for audits.

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