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.
TDL’s Center for Breakthrough Medicines is seeking a highly motivated and independent researcher to lead a group of scientists focused on establishing purification strategies for Adeno-Associated Virus, Lentivirus, and Adenovirus (AAV, LV, and Ad) viral vectors in order to build best-in-class viral vector manufacturing technologies. The Sr. Scientist/Principal Investigator will play a key role in establishing viral producer/packaging cell lines and evaluating other manufacturing technologies. This position will also be responsible for the development of up-stream processes related to viral production and cell line engineering. It is expected that the candidate will have a working knowledge of viral-based production technologies and quality control (QC) techniques and employ design of Experimentation (DoE) to support their work. The Senior Scientist/Principal Investigator position in the Vector Engineering and Manufacturability group at the Discovery Labs offers an exciting opportunity to develop viral purification and analytical strategies for Gene and Cell Therapies to treat many diverse unmet medical needs.
• Be results-driven and reliably meet and exceed client expectations by supporting the program needs of CDMO partners and clients.
• Lead all stages of projects within a matrix organization. Specifically, this includes the introduction of new products into the facility, supporting process development, analytical development, technology transfer of new products to cGMP manufacturing through all stages of clinical development through to commercial.
• Effectively resolve project team issues and facilitate decision making within the team resolving conflicts where necessary.
• Track and manage the financial aspects of the project including milestone payments, pass through costs and FTE estimates to ensure client programs progress on time and on budget.
• Manage progress, issues, and risks of programs of substantial complexity and scale.
• Manage all client interactions, including maintaining and a regular cadence of project meetings, preparing meeting minutes, maintaining an action tracker, and effectively following up with internal and external team members to progress the program and closeout of actions.
• Ensure efficient and effective communications of program/project related information to all levels within the organization and to clients, building trust, transparency and partnerships.
• Develop, improve, and implement program and project management tools and templates for use by the program teams.
• Support department and individual goals and key performance indicators in alignment with the Center for Breakthrough Medicines operational and organizational goals.
• Bring an entrepreneurial mindset and be ready to contribute to the high growth of CBM and the Discovery Labs life sciences community by living into the CBM culture and demonstrating role model leadership.
• Bachelor’s Degree in a relevant scientific or engineering discipline. (Graduate degree is a plus).
• Minimum 10 years related experience in the biopharmaceutical industry, with an understanding of biopharmaceutical CMC development and manufacturing. Experience with CDMO’s either as a client or CDMO employee is preferred.
• Possess working knowledge of biopharmaceutical product development lifecycles with experience managing process development and/or clinical or commercial manufacturing programs.
• 3-5 years’ experience in a Program Team Leadership or Program Management role responsible for the client or internal programs (experience in a contract manufacturing organization is a plus) and a strong understanding of CMC.
• Equivalent combinations of education, training, and relevant work experience will be considered.
• Significant experience leading cross-functional teams to deliver on-time, on-budget, within scope and in compliance with all quality and regulatory requirements.
• Knowledge of cGMPs, regulatory environment, and biopharmaceutical manufacturing.
• Demonstrated expertise in project management including timeline and budget management, communication plans, proactive risk prevention, action tracking and project plans. Experience implementing new tools and business processes to support department efficiency.
• Expert with MS Project, MS Excel, MS PowerPoint, and MS Word.
• Adhere to policies and procedures and ensure a safe and healthy workplace environment.
• Self-motivated with a strong sense of ownership in areas of responsibility.
• Strong planning, problem analysis, and decision-making skills.
• Ability to adapt and manage conflict in a constantly evolving environment.
• Ability to break down complex scenarios and situations into clear and concise points.
• Demonstrated success in organizational and time management skills to deliver projects meeting all stakeholder expectations.
• Exemplary interpersonal skills: should be an effective leader who can manage and lead in a matrix environment while maintaining order and a larger picture perspective.