Executive Director & Head, Sterile Product Development

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The Executive Director& Head of Sterile Product Development will be responsible for leading and developing a high-performance team accountable for all registrational and commercial drug product, primary packaging, analytical support and process development for all portfolio assets intended for parenteral administration, including small molecules, biologics and non-traditional modalities in the BMS pipeline starting at pre-FIH. The successful candidate will have a well-established track record of successful leadership and be responsible for establishing a clearly defined vision and objectives for the team.

MAJOR RESPONSIBILITIES

• Responsible for the design & development of registrational and commercial products, development of novel analytical methodology to support biologic formulation development, primary packaging, analytical method development & control strategies for all small molecule BMS assets intended for parenteral administration, application of new tools and technologies to enable advancement of parenteral assets and accountability for oversight of Drug Product Pipeline Reviews
• Oversee key SPD functions including Formulation & process development, Analytical Method Development/support, and primary packaging development  
• Build high-performance teams that are encouraged and rewarded to implement differentiated and innovative strategies to deliver high-quality products and services to collaborators
• Provide guidance, as required, for parenteral Drug Product Development Teams (1DPD-Teams), ensuring alignment with the goals of BMS R&ED, GPS and Commercial
• Continually evaluate and improve the functional strategic plan that aligns with enterprise level goals, customer needs, resources, and culture
• Develop and maintain effective working relationships and communications within GPS, R&ED, Commercial, Regulatory, and other functional areas and other customer groups.
• Ensure successful transfer of new products and technology to internal and external clinical and commercial manufacturing sites, including generation of knowledge and understanding to support product robustness targets.
• Ensure successful transfer of small molecule drug product analytical methodology to the appropriate GMP testing laboratories
• Ensure compliance with EHS regulations and company policies & procedures
• Implement new technologies and systems to enhance productivity.
• Apply the principles of Leadership Development throughout the organization. Ensures that staff have clearly defined opportunities for development and that all key positions have succession plans
• Instill a sense of urgency, agility and a commitment to science and quality throughout the organization.

EDUCATION/QUALIFICATIONS

• Ph.D. in pharmaceutical sciences, engineering, analytical, biochemistry or related sciences with at least 15 years of experience in pharmaceutical development and a solid record of roles with increasing responsibility.
• In-depth knowledge and understanding of drug product development, commercial technology transfer to manufacturing, CMC related FDA and international regulations.  Able to anticipate industry trends and emerging issues.
• Demonstrated ability to develop and execute business strategy to bring maximum value to the organization.
• Experience interfacing with US, EU, and other health authorities for the clinical development and commercialization of drug products is highly desired
• Must have extensive supervisory and budgetary experience with demonstrated capability to build a high-performance team
• Previous success working effectively in a multidisciplinary, highly matrixed environment

OTHER DIMENSIONS

• Demonstrated managerial and leadership skills in leading group of scientists and engineers, and the ability to work with multifunctional organizations and stakeholders.
• Demonstrated record of selecting talented people and preparing them for leadership roles.
• Demonstrated ability to build a team and develop a high performing organization.
• Excellent decision-making, written and verbal communication skills.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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