The Cell Therapy Manufacturing Supervisor will be responsible for helping to drive the on-time-delivery of manufacturing start-up activities for all aspects of cell therapy manufacturing. The incumbent will lead, guide, and train a diverse manufacturing team by performing routine cGMP manufacturing of clinical and commercial phase Autologous and Allogenic advanced therapeutics supporting at the Center for Breakthrough Medicines.
We’re looking for an individual who is a motivated self-starter and eager to contribute to building a manufacturing operation unparalleled in its capabilities and expertise. The individual should also have a willingness and aptitude for adoption of new technologies, an ability to build relationships and work effectively in a cross-functional team, and commitment to the highest safety and quality standards. This position has the potential to evolve into a manager role.
- Ensure high levels of communication with the team, support resources, and management regarding issue identification and resolution; develop formal communication protocols and tools including progress tracking systems, dashboards, and management reports, and any other product specific information as needed.
- Lead, motivate, and encourage manufacturing personnel to develop skills necessary for promoting an inclusive culture in which safety, compliance, meeting goals/objectives, and continuous improvement are a primary focus.
- Ensures work is completed in compliance with approved SOPs, batch records and controlled documentation and all applicable regulations, guidelines, safety policies and procedures are followed.
- Work closely with manufacturing personnel to troubleshoot process and equipment problems.
- Work closely with Quality Assurance in the resolution of manufacturing deviations/non-conformances and troubleshooting of process and equipment problems.
- Work closely with senior management and cross-functional teams on New Product Introduction projects and assist in designing processes/techniques to meet the team’s goals/objectives.
- Complete same-day review of completed batch records and associated suite documentation.
- Oversees and adjusts training programs within the team, ensuring that manufacturing personnel are current on training requirements.
- Work effectively with cross functional teams comprised of process sciences, development, facilities & engineering, tech ops, quality control, and quality assurance to ensure right-first-time technology transfer.
- Provides timely technical input to support ongoing operations.
- Proactively identify opportunities for improvements in process, safety, quality, and cost.
- Escalate key risks and issues to manufacturing line and senior management team.
- Acts as qualified trainer for SOPs and procedures in functional area.
- Ensure the manufacturing facility is in a cGMP status and a continued state of inspection readiness.
- Promote an “All In” culture within the team by exhibiting inclusiveness, emphasizing safety, and leading continuous improvement activities through leading by example.
- Demonstrate a positive attitude within the team and proven ability to complete assignments on time.
- High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
- A minimum of 5-7 years of experience in cGMP biological manufacturing. Cell Therapy manufacturing or other gene therapy experience is highly preferred.
- A minimum of 2-4 years of leadership experience is preferred.
- Advanced experience working with single-use bioreactors, aseptic operations, equipment, and cell culture, is highly preferred.
- Advanced knowledge of cGMP regulations.
- Advanced efficiency working in a Biological Safety Cabinet (BSC).
- Demonstrated ability working with incubators, pipettes, and micropipettes.
- Demonstrated ability working with sterile tube welders, sterile tube sealers, and cell counting machines.
- Advanced ability to work well independently, as part of a team, and establish working interdepartmental relationships.
- Exhibits extreme attention to detail, accuracy in work, and integrity of character.
- Self-starter who shows eagerness to learn and problem-solve.
- Innovative and efficient when solving problems with a strong focus on continuous improvement.
- Possesses sound technical aptitude to learn and operate production equipment.
- Experience supervising, coaching, mentoring, and developing direct reports.
- Outstanding written and verbal communication skills, with excellent teamwork aptitudes.
- Demonstrated ability to plan daily activities for self and team and resolve problems in area of expertise.
- Ability to lead and develop a team to accomplish individual, department and corporate goals.
- Ability to accommodate off-shift work as required by business demand and manager request.
- Position requires direct interaction with clients and is expected to spend 80-100% of time gowned on the Manufacturing Floor.
- Ability to carry up to 55 pounds.
- Ability to stand for extended periods of time while wearing PPE (Personal Protective Equipment) daily.