Associate Director Tech Product Team Lead
The Program Management Office within Biologics Manufacturing and Process Development (BMPD) 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 GMS functional strategies. The TPT Leader will also work closely with others in the Program Management Office and 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.
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.
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 requiredto 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.
-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 are highly beneficial.
-Excellent interpersonal, collaborative, team building and communication skills.
-Approximately 10-20% travel will be required between BMS sites (Devens, Syracuse, New Brunswick).