Bristol Myers Squibb Associate Director, Product Robustness Lead in New Brunswick, New Jersey
This is a critical role in the Pharma MS&T (Manufacturing Science & Technology) team. The candidate will drive activities which actively measure robustness and reduce risk to our ongoing process and to the commercial supply of BMS pharma products. This person will set and drive the expectations for product robustness both for new product launch from development and for existing products in manufacturing. Accountability for the development of integrated strategies leveraging and incorporating input from our key stakeholders and partners, including the wider MS&T organization.
Develop and implement structures, tools, and process to actively manage process performance/robustness across the portfolio.
Lead activities to define, develop and implement best practices for active supply risk reduction across the commercially manufactured pharma portfolio.
Drive the product robustness strategies for the BMS pharma portfolio and ensure that new pharma products are launched with an appropriate level of robustness.
Assure that robustness monitoring and improvement programs are in place to proactively and continuously reduce risks associated with process performance, while improving process capabilities across the portfolio.
Partner across the MS&T team, and in particular with pharma drug product and API development-to-launch leaders to drive appropriate levels of robustness into new product development projects.
Define and set metrics, and regularly review product performance against these metrics with manufacturing and key stakeholders across BMS pharma portfolio.
Ensure that an active roster of risk prioritized robustness improvement projects is maintained for the pharma product portfolio.
Support, drive and influence a culture of product robustness within MS&T, into product development and throughout BMS. Maintain subject matter expertise, awareness and influence of industry trends and best practices.
Conduct training of best practices to drug product and A&I SMEs
Minimum bachelors of science/engineering in a pharmaceutically relevant science or engineering discipline. Advanced degree (MS/M Eng/PhD) strongly preferred.Experience/Knowledge Desired:
Minimum 12 years work experience in different roles across the pharma industry related to product robustness in development and manufacturing.
Strong awareness of methodologies pertinent to the function and be able to introduce them with limited supervisory input.
Strong statistical and analytical skills are desirable
Strong communication skills, including the ability to present to Sr. Management and global health authorities.
Strong knowledge of health authority guidelines, expectations and best practices around product robustness, QdB principles, and validation.
Demonstrated experience in building relationships and using influence. Can establish credibility and earns respect with a diverse set of internal and external stakeholders including manufacturing partners and other functional managers. Is able to “get things done” without compromising principles. A high level of energy and strong work ethic is critical to success.
Excellent interpersonal, collaborative, team building, and communication skills to ensure effective collaborations within matrix teams. Demonstrated performance against cooperation principles and enterprise mindset.
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.