Scientific Associate Director, Analytical Development

Company: Bristol-Myers Squibb
Location: Summit
Posted on: May 16, 2022

Job Description:

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 will primarily be an individual contributor and leader of a matrix team of analytical scientists, and a core member on the CMC team. The Scientific Associate Director will collaborate across BMS sites with functional Analytical Leads, Drug Substance and Drug Product Leads, Quality Lead, and Regulatory Lead to generate and execute analytical strategies for methods and specifications, analytical control strategies, and support of product development up to drug application submissions. Support drug substance process development and drug product formulation and process development including characterization of the process and finished product, including support of impurity characterization and identification. In-depth knowledge on how to develop, optimize, validate / qualify, and transfer analytical methods. Provide leadership and supervision to scientific staff. Develop, coach and mentor others. Serve on a cross functional team responsible for analytical related CMC strategy development. Review and discuss analytical results and conclusions both orally and in writing. Write/approve formal reports as source documents for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities. Requirements: Fluency in synthetic chemistry, drug substance processing, formulation development, pharmaceutical processing with a deep understanding of pharmaceutical sciences related to drug product development Mastery of chemistry with extensive expertise in measurement science. Experience in the development and performance of analytical tests for a variety of drug substances and products (including solid oral dosage forms and injectables). Knowledge of dissolution method development and testing, and biopharmaceutical classification system. Understands drug development and works to build CMC dossier for regulatory submissions as an author/reviewer. Experience in worldwide commercialization of small molecule drug products, with recent approvals in major markets. The ideal candidate would have a history of drug approvals as an analytical expert in both drug substance and drug product analytical development. Completed BS and minimum of 12 years; MS minimum of 9 years; or Ph.D. and minimum of 7 years in Chemistry (or relevant discipline) with pharmaceutical experience. A demonstrated record of scientific accomplishment, laboratory experimentation, publications, and presentations. Understands writing/approval of risk assessments and understands both GMP and GLP requirements for drug product development. Ideal Candidates Would Also Have: Exceptional verbal and written communication skills and interpersonal skills as a team member/leader in an environment where individual initiative, collaboration and accountability are valued. Familiar with modern laboratory equipment and automation. Understands and applies Quality by Design principles when required. Experience leading Matrix teams. 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. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Bristol-Myers Squibb, New York , Scientific Associate Director, Analytical Development, Executive , Summit, New York