Bristol Myers Squibb ASSOCIATE DIRECTOR, TECH PROD TEAM LEAD in Devens, Massachusetts
The Integrated Technical Strategy (ITS) team in 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 commercial pipeline.
The Technical Product Team (TPT) Leader - Biologics 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 biologic 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 robustness 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:
• TPT leader will work with the functional leads in MS&T (Drug Substance, Drug Product, Analytical, etc.) to create an integrated technical product roadmap, which details out the major projects/process improvements required to support the product’s lifecycle plan.
• TPT leader will partner with project manager to develop full project schedules, budgets, and resourcing for the activities listed on the technical product roadmap.
• TPT leader will actively participate in the Expanded Change Review Board (ECRB) to ensure product quality, compliance and supply requirements are met.
• TPTL leader will develop 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.
• TPT leader will manage and track the completion of all health authority commitments.
• TPT will provide a dedicated forum for issue resolution and active management of the product risk register, including developing the appropriate business continuity plans.
• Bachelor or advanced degree in a life science, engineering or other technical discipline.
• At least 8 - 10 years of technical experience in the commercial manufacturing of biologics drug substance and/or drug product.
• 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).
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.