Team Lead BioPharma Manufacturing Operations SFD-TC

Purpose & Scope

The Supervisor Manufacturing will be a key contributor to manufacturing readiness and future operational output. The role will initially support commissioning and start-up activities as the GMP facility is built. This includes equipment testing, layout planning, SOP and other documentation generation, as well as the recruitment and training of staff. After the startup of manufacturing operations are complete, the role will be responsible for executing a combination of engineering, clinical, and process qualification (PPQ) batches with supporting staff. This role, as part of the Manufacturing leadership team, will be an integral contributor tasked with building a diverse and technically strong team for future successful GMP operations.

Role and Responsibilities

• Ensure seamless transfer of information and responsibilities across shifts and between processing areas
• Hire, train, supervise, and develop subordinate Manufacturing Associates while ensuring all parties are compliant with required GMP training and related documentation
• Support drafting and/or approval of manufacturing documentation, including SOPs and batch records
• Coordinate with other departments to schedule work and other activities that impact manufacturing site milestones and/or process schedules
• Coordinate with Supply Chain and the Warehouse to ensure materials and other consumables are ordered and received in time for both commissioning and production needs
• Support and/or own quality investigations, CAPAs, and other compliance issues, ensuring that process improvement ideas and/or CAPA’s are implemented in a timely manner.
• Support regulatory inspection activities for manufacturing areas, personnel, and procedures
• Attend safety meetings, ensure that staff adheres to all safety procedures as defined, and maintain a safe work environment within manufacturing owned areas
• Review all executed batch records and other documentation generated from the Manufacturing floor and ensure compliance with all approved procedures and cGMP requirements
• Build effective working relationships with cross-functional disciplines, ensuring company goals, process investigations, and improvement initiatives are carried out in an effective and collaborative manner

Qualifications

Required Qualifications

• BS / BA in Chemical/ Biological Engineering or Life Sciences with 4+ years of applicable industry experience or Associate’s degree in science with 6+ years of industry experience or H.S. diploma with 8+ years of industry experience
• 1-2 years of experience leading teams, including peers, in a GMP manufacturing environment
• Technical understanding of a biotech manufacturing facility, with detailed knowledge of fill finish (drug product) operations and working with sterile injectables.
• Proven effective problem-solving skills with an ability react quickly to process challenges
• Strong safety focus with a proven ability to promote safety awareness within manufacturing organization
• Will support and demonstrate quality standards to ensure data of highest quality.
• Outstanding communicator with ability to work independently when required as well as closely within a team that may include external disciplines and key stakeholders.
• Will be expected to perform other duties and/or special projects, as assigned.
• Strong understanding of sterile drug product manufacturing processes and controls, including formulation, sterile filtration, aseptic filling, container closure systems, cleanroom behavior, environmental monitoring, and contamination control.

Preferred Qualifications

• Experience with downstream operations considered an asset.
• Experience with disposable processing equipment
• Experience starting/scaling up a new manufacturing facility
• Excellent aseptic technique

Location and Working Environment

This position is based in Sanford, NC and will require on-site work. This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, regular reaching over head activities, and independent mobility to lift to 25lbs. This is an on-site role working in a cGMP regulated manufacturing facility. On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities or to third parties to support operations (0-5%)