Lead, Manufacturing - Cell Culture (Nights)

About This Role

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.

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.

Who You Are

Our Cell Culture Manufacturing team is looking for an agile, self-motivated leader who thrives in a fast-paced manufacturing environment. You take ownership of your work, act with integrity, and are committed to maintaining the highest standards of safety, quality, and compliance. You bring strong technical expertise in upstream manufacturing processes while supporting the development of others through coaching, training, and collaboration. Success in this role requires excellent communication skills, attention to detail, sound decision making, and the ability to lead by example working across teams and shifts.

Required Skills for Lead, Manufacturing

• 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

Preferred Skills

• 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