Senior Director, CMC Team Leader

Working with Us Challenging. 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. 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: careers.bms.com/working-with-us . At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through   science. In oncology, hematology, immunology ,   cardiovascular , and   neuroscience   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 Scientific Director, CMC Team   Leader   is responsible for   developing and leading   the   execution of   comprehensive,   compound-specific   CMC   strategies   t o   meet   global   R&D   project needs .   Supporting the Product Development portfolio, which includes small molecule s , large   molecules   and new modalities   (conjugates,   peptides   and oligonucleotides) , this unique role   is critical to our   role   turning molecules into medicines.   Primary r esponsibilities of the S cientific   Director , CMC Team Leader :   Leads   the   interdisciplinary matrix teams responsible for developing and executing   compound-specific   integrated CMC strategies that   advance   R&D   Project Team   objectives   and   encompass   drug substance, drug product, analytical, quality, regulatory, and clinical   supplies .   Represents   the Global Product Development and Supply (GPS) organization on   key   R&D Project Teams, actively collaborates   across   functional areas   (Clinical, Commercial, Regulatory, Clinical Pharmacology, Toxicology, etc.)   and influence s   the BMS organization to develop globally optimized   program strategies .   Communicates and partners effectively   across   functional areas within Product Development and other stakeholders (Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC, Commercial Manufacturing, etc.) to define and execute   the   CMC strategy for the project.   Identifies   and escalates key issues ,   risks   and   resource allocation needs, as appropriate   Accountable for   managing   multiple assets   across   large   and s mall molecule s ,   ranging   across phases of development   from candidate nomination, First-in-Human,   and   pivotal   clinical studies ,   through   to   market application approvals   (BLA, NDA)   in partnership with CMC Team Project Manager .   Accountable for   CMC Project budget   and applies financial acumen to evaluate portfolio trends and   anticipate   the impact of strategic inflection points on project trajectories .   Works with a ‘return on investment’ mindset to define project opportunities,   seeking   to   optimize   PDs impact within the broader portfolio.    Influences CMC regulatory strategies and c ritically reviews relevant documents, including but not limited to all CMC regulatory submissions, briefing booklets,   and   information requests .   Champions operational excellence by driving the adoption of best practices and spearheading strategic improvement initiatives , including the adoption of advanced digital capabilities, planning   tools   and program simulation .   P artner s   with the   GPS   Business   D evelopment group   to support Due Diligence evaluations and activities to bring   assets   into the GPS network   and   partner with alliance management ,   as necessary.   Skills/Knowledge Required – Senior Director:   Advanced degree in relevant scientific discipline    1 5 + years of relevant CMC experience in the pharmaceutical industry.    Robust   understanding of how CMC integrates and partners with Non-Clinical and Clinical development, Quality, Regulatory,   Commercial   and other functional areas in pharmaceutical development.   Capable of thinking critically and developing strategic plans that align with long-term business   objectives   and drive innovation.   Excellent verbal and written communication, as well as strong problem-solving, and decision-making skills.   Proven track record of influencing and building strong partnerships with stakeholders across the organization to achieve strategic goals.   Keen sense for value of investment with a proven   track record   of   applying risk-balanced and differential investment principles to enhance CMC operations and drive organizational success .   Demonstrated ability to lead, inspire, and develop high-performing teams while fostering a collaborative and inclusive team culture.   Ability to manage ambiguity and make decisions with limited information, when   required   Experience in multiple modalities   (e.g., biologics, small molecules, antibody-drug conjugates) is a clear plus.   Broad   and deep   understanding of chemical and/or biological, formulation and analytical development and a proven   track record   of l eading CMC teams throughout the development lifecycle, from early-stage development through commercialization    Experience working with external manufacturing organizations (CMOs) and managing complex supply chains and   budget .   Demonstrated success in developing and/or applying