Lead, Manufacturing - Cell Culture (Nights)

Biogen•Research Triangle Park, NC

6d•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, and revision of cGMP documents while ensuring compliance to cGMP and maintenance of equipment and facilities. This position works closely with the Shift Manager to coordinate critical activities collaboratively and utilize resources efficiently. This is a key preparatory role for the Manufacturing Shift Manager position.

Requirements

Bachelor’s degree from an accredited college or university, STEM preferred and at minimum 4 years of direct experience
A BioWorks Certificate or associate's degree, STEM preferred and at minimum 4.5 year of direct experience
A High School Diploma (or equivalent) and at minimum of 5 years of direct experience
Demonstrated experience leading manufacturing activities, coordinating shift work, and training associates in a cGMP environment
Demonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP)
Experience supporting Upstream cell culture manufacturing operations in a pharmaceutical, biotechnology, or related regulated manufacturing environment
Experience working in an aseptic or cleanroom environment
Experience with manufacturing systems such as Trackwise, Delta V, Syncade, LIMS, or similar systems

Nice To Haves

Prior cell culture manufacturing experience in a leadership capacity
Experience with bioreactor operations, Media Preparation, Harvest operations, Aseptic Cell Expansion, and other upstream manufacturing processes

Responsibilities

Execute cell culture manufacturing processing steps and/or manufacturing support activities while monitoring performance against the batch record, electronic systems, and process controls.
Serve as a Subject Matter Expert (SME) for multiple upstream unit operations and lead critical process activities.
Coordinate shift activities in partnership with the Shift Manager, including production execution, validation activities, and project support.
Plan resources effectively and ensure thorough communication during shift changes.
Document, record, and verify cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures.
Develop and/or revise documents as needed. Key documentation includes batch records, SLRs, and equipment logbooks.
Ensure real-time review requirements are met.
Train, mentor, and support Manufacturing Associates while managing personal training requirements.
Observe performance of employees, provide timely and targeted coaching for employees, and share feedback with the Shift Manager at mid-year and year-end.
Initiate and actively participate in deviations investigations, develop and implement corrective and preventative actions as required.
Lead and/or actively participate in troubleshooting.
Serves as possible potential SME for audits and tours.

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