The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.
CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.
The Vector Upstream Manufacturing Supervisor will be responsible for helping to drive the on-time-delivery of manufacturing start-up activities for all aspects of vector upstream manufacturing. The incumbent will lead, guide, and train a diverse manufacturing team by performing routine cGMP manufacture of viral vectors, non-viral vectors, and advanced therapeutics supporting the gene therapy asset 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 develop manufacturing personnel by promoting a culture. of inclusiveness, safety, continuous improvement, training objectives, and compliance.
- 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 to initiate new production projects and assist in developing processes/techniques to meet contract objectives.
- Support the team in defining and executing technical strategies.
- Complete same-day review of completed batch records.
- 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 site leadership team.
- Acts as qualified trainer for SOPs and procedures in functional area.
Education & Experience
- 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. Vector 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, cell culture, and seed scale-up 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.
- Proven experience working with of cell expansion vessels such as T-flasks or shake flasks.
- 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.
- Strong background in process scale-up.
- 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 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 long periods of time while wearing PPE daily.