The Vector Manufacturing Supervisor will be responsible for helping to drive the on-time-delivery of manufacturing start-up activities for all aspects of vector upstream and downstream 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.
- Oversees the manufacturing process, supervises upstream and downstream processing on the floor, and delegates daily work assignments.
- Lead, motivate, and develop manufacturing personnel by promoting a culture of inclusiveness, safety, continuous improvement, training objectives, and compliance.
- Understands and performs aseptic technique and identify unacceptable practices and can make spot corrections to performance.
- 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.
- Understands, trains, and coaches others on all operations, functions, and capability of equipment and is able to perform complex troubleshooting.
- Identifies, suggests with options, recommends path forward and leads complex decision-making sessions.
- Possesses basic and fundamental engineering and mechanical knowledge and is able to apply that knowledge in the manufacturing area, demonstrating unit operational and end-to-end understanding.
- For escalations, works closely with the production staff to troubleshoot process and equipment
- Responsible for maintaining the Vector Manufacturing facility and equipment to ensure constant compliance
- Work closely with Quality Assurance and SPCI in the resolution of manufacturing deviations/non-conformances and troubleshooting of process and equipment problems.
- 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.
- Proactively identify opportunities for improvements in process, safety, quality, and cost.
- Train manufacturing and other team members on manufacturing procedures and especitc techniques, quality systems and compliance, and other operations required for cGMP manufacturing.
- Assist in building out a full team of Vector Bioprocessing Associates at varying levels
- Support CBM culture of “Be Committed, Ignite Innovation, Respect All, Embrace Customers, Empower Small, and Always be All In”.
- High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
- A minimum of 4 years of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy experience is highly preferred.
- A minimum of 1-2 years of leadership experience is preferred.
- Advanced experience working with single-use bioreactors, aseptic operations, cell culture, seed scale-up, filtration, concentration, chromatography, purification, etc. is highly preferred.
- Advanced knowledge of cGMP regulations.
- Advanced efficiency working in a Biological Safety Cabinet (BSC).
- Demonstrated ability working with sterile tube welders, sterile tube sealers, and single-use assemblies.
- Proven experience working with of cell expansion vessels such as T-flasks, shake flasks, cellstacks, hyperstacks.
- 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.
As an Equal Opportunity Employer, we believe in each person’s potential. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or any other protected category including veteran status.