Senior Director, CMC Team Leader
2 days ago
New Brunswick
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. 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 to meet global R&D project needs. Supporting the Product Development portfolio, which includes small molecules, large molecules and new modalities (conjugates, peptides and oligonucleotides), this unique role is critical to our role turning molecules into medicines. Primary responsibilities of the Scientific 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 influences 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 small molecules, 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 critically 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. Partners with the GPS Business Development 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, • 15+ 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 diverse 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 leading 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 innovative solutions to complex CMC technical challenges., • Strong knowledge of global regulatory guidelines and requirements (e.g., FDA, EMA, ICH guidelines)., • Embraces BMS shared values of passion, innovation, urgency, accountability, inclusion, and integrity Compensation Overview: New Brunswick - NJ - US: $234,100 - $283,672 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: • Health Coverage: Medical, pharmacy, dental, and vision care., • Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP)., • Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off • US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees), • Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. 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 a supportive culture, promoting global participation 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 BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of