Senior Director, CMC Team Leader

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: Bristol Myers Squibb we are inspired by a single vision transforming patients lives through oncology hematology immunologycardiovascular andneurosciencedisease and one of the most diverseand promising pipelines in the industry each of our passionate colleaguescontributeto innovations thatdrive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make adifference.

The Scientific Director CMC TeamLeaderis responsible fordeveloping and leadingtheexecution ofcomprehensivecompound-specificCMCstrategiestomeetglobalR&Dproject needs.Supporting the Product Development portfolio which includes small molecules largemoleculesand new modalities(conjugatespeptidesand oligonucleotides) this unique roleis critical to ourroleturning molecules into medicines.

Primary responsibilities of the ScientificDirector CMC Team Leader:

• Leadstheinterdisciplinary matrix teams responsible for developing and executingcompound-specificintegrated CMC strategies thatadvanceR&DProject Teamobjectivesandencompassdrug substance drug product analytical quality regulatory and clinicalsupplies.

• Representsthe Global Product Development and Supply (GPS) organization onkeyR&D Project Teams actively collaboratesacrossfunctional areas(Clinical Commercial Regulatory Clinical Pharmacology Toxicology etc.)and influencesthe BMS organization to develop globally optimizedprogram strategies.

• Communicates and partners effectivelyacrossfunctional areas within Product Development and other stakeholders (Quality Toxicology DMPK Clinical Pharmacology Regulatory CMC Commercial Manufacturing etc.) to define and executetheCMC strategy for the project.Identifiesand escalates key issuesrisksandresource allocation needs as appropriate

• Accountable formanagingmultiple assetsacrosslargeand small moleculesrangingacross phases of developmentfrom candidate nomination First-in-Humanandpivotalclinical studiesthroughtomarket application approvals(BLA NDA)in partnership with CMC Team Project Manager.

• Accountable forCMC Project budgetand applies financial acumen to evaluate portfolio trends andanticipatethe impact of strategic inflection points on project trajectories.Works with a return on investment mindset to define project opportunitiesseekingtooptimizePDs impact within the broader portfolio.

• Influences CMC regulatory strategies and critically reviews relevant documents including but not limited to all CMC regulatory submissions briefing bookletsandinformation requests.

• Champions operational excellence by driving the adoption of best practices and spearheading strategic improvement initiatives including the adoption of advanced digital capabilities planningtoolsand program simulation.Partnerswith theGPSBusinessDevelopment groupto support Due Diligence evaluations and activities to bringassetsinto the GPS networkandpartner with alliance managementas necessary.