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.
CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.
The Discovery Labs is a Global Platform Company inclusive of CBM, The Discovery Labs Properties, UniteIQ incubator labs, and The Colony, a unique investment and resource model enabling groundbreaking therapies to be brought to life.
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.