Manager, Manufacturing

Position Summary

The Manufacturing Manager I leads and drives the execution of manufacturing processes according to established electronic work instructions and production records for the manufacture of cell therapies with Current Good Manufacturing Practices (cGMP's). The Manager I is responsible for leading a team whose primary focus is on execution of manufacturing processes, technical assessment of processes, and driving a culture of safety, compliance, and innovation within their functional group. The Manager I plays a crucial role in guiding personnel in their group with technical expertise to lead troubleshooting activities, provide investigation support, analyze process/equipment data, and identify and implement process improvements. This role also creates an environment that fosters idea generation, team and cross-functional collaboration, and execution of success, repeatability, and reliability of process and staff.

Duties/Responsibilities

• Manages the creation, implementation and compliance of all Source Governing Documents (including but not limited to: Standard Operating Procedures, Work Instructions, Batch Records, Forms) related to cell therapy operations for self and others
• Oversee operations within the requirements of a validated manufacturing system(s)
• Plan, assign resources and oversee daily operational activities associated with assigned areas of responsibility while controlling costs
• Maintain operating and storage areas to ensure that they are compliant, efficient, effective, safe and always inspection ready
• Drives right-first-time initiatives and holds team accountable for compliance performance. Generates solutions for compliance issues.
• Prepares, gains alignment and implements Change Controls
• Completes MRB slides and presents at MRB meetings as needed
• Initiates change controls, notice of events, deviations and investigations and drives actions to closure as assigned
• Evaluates team performance and drives continuous improvement of cost, quality, safety, culture and delivery. Identify strategic and operational issues to prevent deviations and maintain a compliant environment.
• Lead and manage the development of corrective and preventative actions, deviation responses and investigations
• Verify manufacturing associates and team leads are fully trained on respective curricula to maintain compliance prior to performance any GxP task.
• Create an environment of teamwork, open communication, and a sense of urgency. Foster a culture of safety and compliance that embraces safety in the work environment, including psychological safety, and the safety of the patients by compliance with company procedures and policies, and cGMP requirements
• Efficiently coordinate, communicate, and provide Operations project information and activities status to Planning, Manufacturing, Quality Assurance / Operations, Global Supply and other associated functions in a timely manner and in accordance with schedules and defined implementation timelines
• Presence in the cell therapy manufacturing facility to participate in walk throughs, provide process troubleshooting, participate in event triages, and have direct contact with manufacturing personnel in order to provide timely, effective coaching.
• Oversee operators on daily basis as they: Perform unit and support operations described in Source Governing Documents in a safe and GMP compliant manner
• Complete documentation contemporaneously required by Source Governing Documents.
• Maintain training compliance by completing all training assignments to ensure the necessary technical skills and knowledge
• Assist in the setup of manufacturing areas and equipment/fixtures, facility and equipment commissioning, and qualification and validation activities
• Write manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
• Hire, mentor and develop exceptional people. Conduct effective performance reviews with supporting documentation and identify opportunities for career growth for manufacturing associates. Immediately address performance issues through document coaching / feedback as required.

Qualifications

Education: Bachelors in relevant science or engineering discipline, or equivalent in work experience

Experience: 5+ years of experience in cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience with 2 years leadership experience (i.e. lead or equivalent) including performance management responsibilities is highly desirable

Experience in the following is highly preferred: Cell therapy manufacturing; Aseptic processing in ISO 5 biosafety cabinets and universal precautions for handling human derived materials in BSL-2/ML-1 containment areas; Cell expansion using incubators and single use bioreactors, Cell washing processes, Cell separation techniques and cryopreservation processes and equipment.

Working Conditions

• Must be able to stand/walk for extended periods of time.
• Must be able to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets (as needed), which require gowning and personal protective equipment (PPE), including by not limited to: safety shoes, safety glasses, aprons, face shields, powered air purifying respirators (PAPR), lab coats, full body gowns, hairnets, gloves, and hearing protection.
• Required to carry and/or lift up to 30 pounds, 15 kg, several times a day, while handling production equipment and/or materials.
• Required to push and/or pull up to 50 pounds, 25 kg, several times a day, while handling production equipment and/or materials.
• Work is areas that may have strong magnets.
• Must be able to work in a BSL2 / ML-1 work environment handling human blood components
• Work in areas with exposure to vapor phase liquid nitrogen
• Must be able to work assigned shift (Day, Evening, Night, Weekends and/or Holidays)