Lead, Manufacturing

About the role

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.

Responsibilities

• Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR and control system.
• Covers and/or leads process steps as required, serving as a process step(s) expert.
• 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.
• Ensures completeness of BPR/SLR real time review.
• Participates in training activities, manages 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.

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.

Preferred Skills

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

Qualifications

• Required Skills: Bachelor’s Degree in an engineering or scientific discipline preferred + 4 years of direct biomanufacturing experience.
• Preferred Skills: 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.