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Job Details


Bristol-Meyers Squibb, Co.

Scientific Associate Director, Pharma MS&T

Pharmaceuticals

All

Full Time

On Site

No

New Brunswick, New Jersey, United States

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.

Scientific Associate Director, Pharma MS&T

Role

  • Develop integrated systems and processes for collaboration across the Pharmaceutical Development (PD)/Commercial interface
  • Lead assessments on new products, issuing formal technical reports and /or adding to key development milestones review forums.
  • Ensure process feedback is incorporated into development strategy through attendance of key projects weekly technical meetings with PD. Expand project knowledge through 1-1 sessions with Lead Researchers in PD, shadowing of lab work and pilot plant campaigns, stakeholder in the design of experiments etc.
  • Assist the PD group with technology selection, process development and optimization.
  • Evaluate process gaps prior to validation and partner with PD to prioritize execution plan. Ownership of generation of continuous improvement ideas post validation, which support reduction of residual risks and overall cost of goods.
  • Designee for Pharma MS&T on CMC development teams and Material Science development teams (MSDTs). Partake in meetings and flag key milestone to management that can influence next stages in the process, as well as push development boundaries. Serves as the Pharma MS&T partner to external manufacturing group based in Ireland.
  • Partake in early and late stage quality risk assessments as well as joint API/DP risk assessments. Act as a facilitator for the risk assessment process.
  • Maintain awareness of advances in existing and new technologies, assess and evaluate impact on existing CMO supplier base.
  • Assess manufacturing requirements and capabilities prior to the transfer of a new process into manufacturing facilities through vendor visits and gain on the floor experience prior to validation through clinical campaign visits.
  • Maintain relationship on projects prior to route selection, as needed. Promote communication between the departments, including meetings facilitation, progress tracking, and updates to leadership.
  • Contribute to the development of ways or working across multiple groups and functions within BMS, such as PD, strategic product leads, CMC development teams etc.
  • Support CMO/vendor selection – prepare technical information packages, leading technical due diligence and site assessments, technical evaluation of RFIs and RFPs, where required. Define capabilities required at the CMO to support new product introduction
  • Report to the Project Management Office (PMO) on pipeline products, where required
  • Coaching of New Product Leads/Project Managers in External Manufacturing, based on development interactions and process knowledge gained through development.

Qualifications and Experience required

  • PhD in scientific or engineering discipline, with at least 10 years or Masters with at least 12 years of experience in product development and relevant industrial experience in the pharmaceutical industry. Experience in leading new product introduction is desirable.
  • Recognised technical leader and subject matter expert in API process development and scale-up, technology transfer, process management, trouble-shooting and optimisation, and relevant synthesis and degradation chemistry. Awareness of downstream processing, and impact API properties has to DP processing would be of benefit.
  • Complete knowledge of process, engineering, analytical and regulatory requirements (cGMP, filing, EHS).
  • Demonstrated project management and technical leadership capability. Ability to build effective teams made up of diverse contributors
  • Demonstrated experience in building relationships and using influence. Can establish credibility and earns respect with a diverse set of internal and external stakeholders including senior executives, manufacturing partners and other functional managers. Is able to “get things done” without compromising ethics. A high level of energy and strong work ethic is critical to success.
  • Excellent communication and negotiation skills are required for this position as well as the ability to translate technical issues into business impact and relevant solutions.

#LI-Hybrid

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 . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.