Executive Director, Parenteral Manufacturing Science and Technology

Bristol Myers Squibb•New Brunswick, NJ

1d•$289,820 - $351,199•Onsite

About The Position

The Executive Director for Parenteral Manufacturing Science and Technology is accountable for the scientific & technical stewardship of sterile drug product (small and large molecule) manufacturing — from initial technology transfer and validation at the start of commercialization through lifecycle management — across BMS' internal and external manufacturing network. This leader has direct accountability for the Manufacturing Science & Technology organization at internal sites, including new sterile Drug Product expansions, process engineering, technical transfer, validation, and investigations activities. This leader oversees a team of scientists and engineers responsible for ensuring process robustness, reliable supply, technical compliance, and continuous improvement across internal Parenteral manufacturing sites and the external network. The role ensures alignment with global health authority requirements (e.g. FDA, EMA, PMDA, Health Canada and other global health authorities; ICH Q7–Q12 and other guidelines and standards applicable to sterile/parenteral manufacturing) and provides strategic leadership to enable innovation, scalability, and efficient global supply of Parenteral products.

Requirements

In-depth knowledge and understanding of the parenteral drug development process and CMC and GMP requirements related to FDA and international regulations; able to anticipate industry trends and emerging issues.
Demonstrated ability to develop and execute organizational/business strategy to bring maximum value to the organization.
Demonstrated ability to effectively develop and lead high-performing global organizations of industry-leading and highly talented experts.
Experience developing and implementing strategy to optimize processes and proactively manage risk.
Strong strategic awareness and an ability to successfully navigate complex, matrix organizations.
Ability to travel on an as-needed basis.
Master's or Ph.D. in a relevant engineering or science discipline (chemistry, pharmacy, biology, chemical engineering, or a related pharmaceutical science); Master's or Doctoral degree preferred.
15+ years of experience in the biopharmaceutical or applicable industry in product and process development and commercialization in a global environment, including direct, hands-on site experience.

Nice To Haves

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Responsibilities

Define and execute the technical strategy for the global Parenteral (small and large molecule) drug product manufacturing network, from technology transfer through lifecycle management.
Direct the MS&T organization for the Sterile Drug Product expansion projects, including process and facility design through commissioning, qualification, regulatory inspections, and operation.
Partner with Product Development to ensure successful commercialization of the development portfolio, including filing strategies and specification setting, process design and control strategies, and PPQ strategy and execution.
Represent MS&T and commercial manufacturing operations at critical decision points in the pipeline review process, and represent MS&T internally and externally to BMS with authority on formulation, processing, and filling of Parenteral products.
Own the end-to-end technical success of process transfers and new product launches, ensuring effective technical input on equipment and materials early in the technical transfer process.
Oversee the validation programs within MS&T to assure compliance with regulatory requirements and the efficacy, repeatability, and robustness of manufacturing processes and associated equipment.
Oversee Process Engineering as part of Tech Transfer/New Product launch activities and routine process support.
Lead CMC authoring activities for Drug Product manufacturing.
Own data management and process monitoring activities to ensure appropriate process robustness and yields.
Ensure timely completion of technical deviations and appropriate change management for Parenteral products.
In collaboration with other functions, ensure effective systems and business processes are in place across the network, to assure compliance with corporate guidelines for Technology Transfer, Validation, and Raw Material Qualification.
Maintain compliance with all relevant EH&S requirements, security guidelines, and current Good Manufacturing Practices (cGMPs) across the network.
Support site selection decisions, covering technical and process aspects, across the internal and external manufacturing network.
Drive effective working relationships with other functional organizations, such as Quality, Operations, Engineering, Global Regulatory Sciences, and the Micro CoE, both internally and externally.
Provide hands-on leadership and integration of the process engineering, technical transfer, validation, and investigations teams that are part of the Parenteral MS&T organization and new Manufacturing Science & Technology organizations as the network expands.
Provide leadership and direction through multiple levels of managers and/or expert-level individual contributors across varied departments and multiple sites.
Attract, lead, and develop a world-class team of scientists and engineers; ensure a program is in place to maintain and develop appropriate subject matter expertise in relevant unit processes, as well as related regulatory and compliance requirements, for the commercial manufacture of Parenteral products.
Identify and champion industry best practices related to validation, technology transfer, sterile processing technology, investigations, and process support across the network.
Identify and implement commercial process and lifecycle improvements, including evaluation and implementation of innovative technologies to improve process control and efficiency in manufacturing operations.
Build and nurture an innovation ecosystem to support the development and deployment of advanced manufacturing technologies for enhanced process capabilities.

Benefits

wellbeing support
retirement and financial protection benefits
insurance offerings (medical, dental, vision, life and disability)
Flexible Time Off (FTO)
11 paid company holidays each year
160 hours of paid vacation annually for new hires
3 optional holidays
paid sick leave
up to two paid volunteer days per year
summer hours flexibility
leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
annual Global Shutdown between Christmas Day and New Year's Day