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    Scientific Director/Senior Director, CMC Team Leader - New Brunswick, NJ, United States - Bristol-Myers Squibb

    Bristol-Myers Squibb
    Bristol-Myers Squibb New Brunswick, NJ, United States

    3 weeks ago

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    Description
    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.

    From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

    You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.

    Take your career farther than you thought possible.
    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.


    Read more:
    CMC Team Leader is responsible for developing and leading the execution of comprehensive, compound-specific CMC strategies to meet global R&D project needs.

    Primary responsibilities of the CMC Team Leader:

    Provides leadership to interdisciplinary, matrix teams responsible for developing and executing compound-specific integrated CMC strategies that drive R&D Project Team objectives and incorporate all elements across the drug substance, drug product, analytical, quality, regulatory, and clinical material spaces.

    Accountable for managing multiple assets, large molecule and/or small molecule, ranging from candidate nomination, First-in-Human, and pivotal clinical studies, to intended commercial formulation and manufacturing processes with appropriate control strategies.

    Represents the Product Development organization on R&D Project Teams and actively collaborates with other functional areas (Clinical, Commercial, Regulatory, Clinical Pharmacology, Toxicology, etc.) to achieve the best development and business results for the company.

    Communicates and partners effectively with functional areas within Product Development and other stakeholders (Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC, Commercial Manufacturing, etc.) to define and execute CMC strategy for the project.

    Identifies and escalates key issues and risks as well as resource allocation needs, as appropriateCritically reviews relevant documents, including but not limited to all CMC regulatory submissions, briefing booklets, information requests, etc.

    Leads or contributes to continuous improvement initiatives across the enterprise.

    Partners with the Business Development group to support or lead Due Diligence evaluations and activities associated with bringing in new assets and will partner with alliance management as necessary.


    Skills/Knowledge Required:

    CMC Team Leader, DirectorAdvanced degree in relevant scientific disciplineAt least 12 years of relevant CMC experience in the pharmaceutical industry.

    Small molecule or experience in multiple modalities is a plus.

    Relevant strategic and tactical project and team leadership experienceBroad understanding of analytical, chemical, and formulation development and a proven track record in CMC development for clinical stage programsSolid understanding of how pharmaceutical development integrates and partners with Quality, Regulatory CMC, Non-Clinical, Clinical, and other functional areas.

    Excellent verbal and written communication skills and the ability to effectively work across levels, functions, and with both internal and external stakeholders.

    Strong sense for value of investment, ability to manage ambiguity and make decisions with limited informationEmbrace BMS shared values of passion, innovation, urgency, accountability, inclusion and integrity


    Skills/Knowledge Required:
    CMC Team Leader, Sr.

    DirectorAdvanced degree in relevant scientific disciplineAt least 15 years biopharmaceutical industry experience and at least 5 years serving as a CMC team leaderTrack record of experience leading CMC teams for small molecules, biologics, and/or novel modalities (e.g., antibody-drug conjugates, gene therapies, synthetic peptides, antisense oligonucleotides, etc.)Broad understanding of analytical, chemical, and formulation development and a proven track record in CMC development for clinical stage programsSolid understanding of how pharmaceutical development integrates and partners with Quality, Regulatory CMC, Non-Clinical, Clinical, and other functional areas.

    Excellent verbal and written communication skills and the ability to effectively work across levels, functions, and with both internal and external stakeholders.

    Experience leading enterprise-level initiativesExperience in playing a leadership role in partnered or acquired drug development programs and representing PSI and GPS as part of any AllianceExperience negotiating complex CMC issues with global regulatory agenciesStrong sense for value of investment, ability to manage ambiguity and make decisions with limited information.

    Embrace BMS shared values of passion, innovation, urgency, accountability, inclusion and integrityIf 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 CareersWith 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 ProtocolPhysical 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 Visit 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.

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

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