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 Associate Director- Vector Manufacturing will be responsible for helping to drive the on-time-delivery of manufacturing start-up activities for all aspects of vector manufacturing. The incumbent will be responsible providing oversight and leadership for the 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.
· Oversight of the manufacturing operations and facility upkeep for designated area and ensure daily use of the operating mechanisms and lead execution of cross functional support teams.
· Responsible for driving the on-time delivery of manufacturing start-up activities for all aspects of vector manufacturing, specifically in performance areas.
· Provide technical leadership for the overall manufacturing operations for viral vector products and advanced therapies.
· Accountable for the performance of team to ensure maintaining a culture of safety, quality, delivery, and operational excellence.
· Responsible for escalation and driving cross functional teams.
· Understands, determines, and drives maintenance teams to fulfill requirements (preventative and calibration) of equipment and works with vendor to resolve issues and escalates when downtime is accumulating.
· Assist with operational budgets and capital plans in support of company and departmental objectives, as required. Drives performance goals and boards at N-1 and N-2 levels to ensure we are hitting CBM financial goals.
· Partner with internal development teams and external collaborators to develop and commercialize products.
· Drives the on-time delivery of required QMS documents and operational readiness plans making sure, which can include review and approve SOPs, validation protocols, and reports related to process and equipment, as required.
· Accountable for in FATs/SATs/Commissioning and qualification.
· Support the establishment of key performance indicators in alignment with individual, department, and company goals. Maintain and report organizational metrics.
· Accountable for the develop a training program for manufacturing staff to ensure team members have a clear understanding of manufacturing & compliance procedures and the science behind the procedures.
· Lead and support GMP readiness activities for manufacturing area start-up and new product introduction.
· Client facing to support tech transfer activities and support the Manufacturing Partner-In-Plant.
· Support internal quality audits, supplier audits, and regulatory inspections and responses.
· Collaborate with SPIC and MSAT to develop and transfer new products to manufacturing.
· Assist Regulatory in the preparation of global regulatory filings and serve as a key subject matter expert during regulatory interactions.
· Provide effective leadership to the manufacturing operations team to ensure the execution of objectives and the development of employees. Support main performance area but cross train to support all of vector.
· Drive an operational excellence culture with a focus on continuous improvement, right-first time and mistake-proofing principles, and lean implementation.
· 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. Drive and own L2 meetings.
· Proactively identify opportunities for improvements in process, safety, quality, and cost, and support and track performance area initiatives.
Support CBM Culture of “Be Committed, Ignite Innovation, Respect All, Embrace Customers, Empower Small, and always be All In”.
Additional duties as assigned.
· Bachelor’s Degree in biological science(s) field or related engineering with a minimum of 6 years in Vector Manufacturing, or 10 years of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy experience is highly preferred.
· 3-4 years of project owner/management experience preferred.
· 3-4 years of leadership experience is preferred.
· Outstanding communication skills (verbal and written).
· Excellent computer and word processing skills including Microsoft Excel, PowerPoint, and Word.
· Working knowledge of GMP systems for: inventory management, asset management, sample management, quality management, and learning management.
· Experience with some or all the following manufacturing processes: adherent and suspension Upstream processing, transfection, harvest and clarification, chromatography, UFDF, sterile filtration, filling, etc.
· Hands-on experience in scale-up and clinical/commercial scale manufacturing.
Must have the ability to gown in a clean room environment and apply required PPE for some period to perform audits, GEMBA walks, and tours.