Associate Scientific Director Jobs

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Position Summary

The Associate Scientific Director will be an analytical team lead (ATL) for drug candidates across all stages of development and, as needed, within our commercial product portfolio. They will serve as a member of a cross functional CMC team responsible for analytical related CMC strategy development. Collaborating with various functional areas, they will identify drug substance and drug product critical quality attributes and establish controls and testing to deliver quality products.

They will drive analytical controls adhering to ICH guidelines and Health Authority requirements. The Associate Scientific Director will have a direct impact on the division and also influence in the broader BMS community.

Key Responsibilities

Associate Scientific 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 Associate Scientific 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 the product quality.

• Experience in managing external manufacturing and testing laboratories as required for the product.
• Understanding of product critical quality attributes and establish methods, specifications, analytical control strategies for product development.
• In-depth knowledge on method development, validation, and tech transfer.
• Provide leadership and mentoring to scientific staff. Develop, coach and mentor others in matrix environment.
• Review and discuss analytical results and conclusions both orally and in writing.
• Serve on a cross functional team responsible for analytical related CMC strategy development.
• Well versed in ICH and country specific requirements to support analytical control strategy.
• Author/ review/approve reports as source documents for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.

Qualifications & Experience

• 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.
• Understands drug development and works to build CMC dossier for regulatory submissions as an author/reviewer.
• Mastery of chemistry with extensive expertise in measurement science.
• Understands writing/approval of risk assessments and understands both GMP and GLP requirements for drug product 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.
• Knowledge of dissolution method development and testing, and biopharmaceutical assessment.
• Experience in the development and performance of analytical tests for a variety of drug substances and products (including solid oral dosage forms, topicals, parentals etc.).
• A demonstrated record of scientific accomplishment, laboratory experimentation, publications, and presentations.
• Fluency in synthetic chemistry, drug substance processing, formulation development, pharmaceutical processing with a deep understanding of pharmaceutical sciences related to drug product development

Ideal Candidates Would Also Have:

• Experience leading Matrix teams.
• Understands and applies Quality by Design principles when required.
• 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.

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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