Lead, Manufacturing - Large Scale Purification (Days)

• Shift Details: This role follows a 2-2-3 calendar rotation on days (6:00 AM – 6:00 PM ET)
• Internal Shift Details: Red 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 the shift Supervisor to coordinate critical activities collaboratively and utilizes resources efficiently. This is a key preparatory role for the Manufacturing Supervisor position.

What You’ll Do

• 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. Also, 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 revise 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 the Supervisor at 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

Who You Are

You’re driven by a mission to save lives and bring a deep sense of purpose to the work you do. Biomanufacturing is complex, and you thrive in fast-paced environments where learning agility, problem-solving, and adaptability are essential.

Required Skills for Lead, Manufacturing

• The following combination of academic and/or relevant experience may be considered:
• 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 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 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

Preferred Skills

• Prior Purification experience in a leadership capacity
• Lean, Six Sigma and 5S certifications