Principal Scientist (R1551137-en-us)
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 Principal Scientist - Analytical Product Lead serves as the point of a contact for BMS on the strategy & technical leadership for Pharma Product assets for the Analytical Science & Technology organization within the operation divisions. This role requires leadership of a matrix team of Analytical Scientists supporting commercialized and late-stage pharmaceutical products with a focus on providing technical partnership on the analytical CMC strategy, enabling regulatory filings, providing technical partnership for managing the life cycle of specifications, and authoring/reviewing responses to health authority questions on commercial products. This is a commercial Analytical CMC leadership role and requires late stage and preferably commercial analytical CMC experience.
The Principal Scientist will collaborate across BMS sites with analytical development, global quality product leads, technical project teams, and regulatory-CMC leads to generate and execute the commercial strategies for drug substance and drug product methods and specifications, network analytical control strategies, and support of life cycle regulatory filings.
The Principal Scientist will be responsible for leading a matrix team responsible for preparation of licensure applications, rest of world filings, follow-up measures, and prior approval submissions.
Through strong leadership, the Principal Scientist will ensure the support of analytical specifications and related change control across the BMS network, for third party manufacturing and our partners at outside testing labs.
Create and maintain effective partnerships with stakeholders from analytical development, manufacturing sciences and technology, Supply Chain, Regulatory, Quality, Process Sciences, Drug Product Development, Project Management, and Manufacturing to deliver analytical strategies with a high probability of technical and regulatory success.
Supervise the management of analytical activities for late-stage and commercial programs.
Leads effective matrix analytical support during all NDA, MAA, ROW & PAS filing review and works with analytical development, MLC, Stability in supporting the responses to FUMs and PMCs.
As analytical SME, co-leads the effort to implement effective control strategy, analytical specification change control as needed throughout the BMS network, third party manufacturing and outside testing labs.
Coordinates optimization and improvement of analytical program support.
Serves as project expert during inspections.
A PhD, MS, or BS in Analytical Sciences, Chemistry, or related disciplines with at least 8, 11 or 13 years of industrial experiences in relevant fields, respectively.
Must have a minimum of 5 years' experience with small molecules.
Demonstrates a broad expertise and knowledge in analytics routinely used for in-process, release and stability testing of small molecule drug substance and drug product. Experience in product characterization and strategies to establish process and product knowledge.
Experienced in analytical control strategies.
Comprehensive knowledge of regulatory requirements for analytical post approval changes, RoW filing requirements, working knowledge of cGMP requirements
Experience authoring/reviewing regulatory submissions, address Health Authority questions.
Demonstrated leadership capability (via direct supervision or leadership of matrix teams).
Strong communication and leadership skills in a highly interactive environment.
Demonstrated skills in leading cross-functional strategic teams and collaboration with internal and external partners.
Strong decision making 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.
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.
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