Associate Director, Technical Product Team Lead
About the Job
At Bristol-Myers Squibb, we believe that together we can make the difference. We want to do this by building professional teams who can create and innovate medicines that benefit doctors and their patients.
Our large-scale biologics manufacturing facility in Devens, Massachusetts, is expanding and there are a number of exciting career opportunities to join Bristol-Myers Squibb, one of the world’s leading BioPharma companies.
We’ve created one of the world’s premier biologics facilities, among the first sites in the industry to have a fully automated, integrated manufacturing control system that enables the plant to run virtually paperless. It is a site that combines biologics development with clinical and commercial manufacturing on a single campus – a true biologics center of excellence for the company where teams are encouraged to closely collaborate. This expansion was designed to support the launch of new medicines by more closely aligning biologics development and manufacturing capabilities. All this goes towards helping create and innovate life-saving medicines that fight serious illnesses.
The Integrated Technical Strategy team in Biologics Manufacturing, Science and Technology (MS&T), is responsible for providing leadership and direction to the technical teams focused on the development, manufacturing and process lifecycle management of the BMS biologics pipeline.
The Technical Product Team (TPT) Leader is accountable for leading an interdisciplinary technical team of scientists and engineers to develop, manage, and execute a complete CMC strategy for BMS biologics commercial products. The TPT Leader will manage one or more biological commercial products depending upon their degree of technical complexity and workload demands. The TPT Leader is a key member of the Global Operations (GO) Team and is responsible to develop and deliver on the CMC strategy while ensuring that the strategy aligns with the overall brand and GPS functional strategies. The TPT success will be measured by maintaining supply continuity, meeting customer service targets, successfully achieving regulatory approval of the technical agenda elements, and achieving process robustment milestones. The TPT Leader will also work closely with various internal governance committees to agree upon project prioritization and resulting timelines to assure that the technical teams are resourced to meet their objectives.
Additional responsibilities include;
• Working with the functional leads in MS&T, Drug Product MT and AD&T to create a technical product roadmap, which details out the major projects/process improvements required to support the product’s lifecycle plan.
• Developing full project schedules, budgets, and resourcing for the activities listed on the technical product roadmap.
• Actively participating in the Expanded Change Review Board (ECRB) to ensure product quality, compliance and supply requirements are met.
• Developing continuous improvement initiatives to help improve the overall efficiency and effectiveness for the management of our commercial product pipeline and deliver on process robustness priorities.
• Managing and tracking the completion of all health authority commitments.
• The technical team will provide a dedicated forum for issue resolution and active management of the product risk register, including developing the appropriate business continuity plans.Qualification:
- Bachelor degree in a life science, engineering or other technical discipline (e.g., biology, chemistry, pharmacy, chemical/biochemical engineering).
- At least 8 - 10 years of technical experience in the commercial manufacturing of biologics drug substance and/or drug product with direct experience in participating on and leading technical project teams in a highly matrixed environment.
- Knowledge of CMC regulatory and analytical testing requirements is strongly preferred.
- Ability to effectively utilize project management and Lean Six Sigma tools is a plus.
- A developed business acumen and advanced quantitative analysis skills highly beneficial.
- Excellent interpersonal, collaborative, team building and communication skills.
- Approximately 10-20% travel will be required between BMS sites (Devens, Syracuse, New Brunswick).