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Senior Director, CMC Team Leader

RayzeBio · New Brunswick, NJ

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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: <a href="https://careers.bms.com/working-with-us" target="_blank">careers.bms.com/working-with-us</a>.<div><div>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. </div><div>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. </div><div>Primary responsibilities of the Scientific Director, CMC Team Leader: </div><div><ul><li>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. </li></ul></div><div><ul><li>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. </li></ul></div><div><ul><li>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 </li></ul></div><div><ul><li>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. </li></ul></div><div><ul><li>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. </li></ul></div><div><ul><li>Influences CMC regulatory strategies and critically reviews relevant documents, including but not limited to all CMC regulatory submissions, briefing booklets, and information requests. </li></ul></div><div><ul><li>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. </li></ul></div></div><div><div>Skills/Knowledge Required – Senior Director: </div><div><ul><li>Advanced degree in relevant scientific discipline </li></ul></div><div><ul><li>15+ years of relevant CMC experience in the pharmaceutical industry. </li></ul></div><div><ul><li>Robust understanding of how CMC integrates and partners with Non-Clinical and Clinical development, Quality, Regulatory, Commercial and other functional areas in pharmaceutical development. </li></ul></div><div><ul><li>Capable of thinking critically and developing strategic plans that align with long-term business objectives and drive innovation. </li></ul></div><div><ul><li>Excellent verbal and written communication, as well as strong problem-solving, and decision-making skills. </li></ul></div><div><ul><li>Proven track record of influencing and building strong partnerships with stakeholders across the organization to achieve strategic goals. </li></ul></div><div><ul><li>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. </li></ul></div><div><ul><li>Demonstrated ability to lead, inspire, and develop high-performing teams while fostering a collaborative and inclusive team culture. </li></ul></div><div><ul><li>Ability to manage ambiguity and make decisions with limited information, when required </li></ul></div><div><ul><li>Experience in multiple modalities (e.g., biologics, small molecules, antibody-drug conjugates) is a clear plus. </li></ul></div><div><ul><li>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 </li></ul></div></div><div><div><ul><li>Experience working with external manufacturing organizations (CMOs) and managing complex supply chains and budget. </li></ul></div><div><ul><li>Demonstrated success in developing and/or applying innovative solutions to complex CMC technical challenges. </li></ul></div><div><ul><li>Strong knowledge of global regulatory guidelines and requirements (e.g., FDA, EMA, ICH guidelines). </li></ul></div><div><ul><li>Embraces BMS shared values of passion, innovation, urgency, accountability, inclusion, and integrity </li></ul><div><div>Skills/Knowledge Required - Director: </div><div><ul><li>Advanced degree in relevant scientific discipline </li></ul></div><div><ul><li>12+ years of relevant CMC experience in the pharmaceutical industry. </li></ul></div><div><ul><li>Solid understanding of how CMC integrates and partners with Non-Clinical and Clinical development, Quality, Regulatory, Commercial and other functional areas in pharmaceutical development. </li></ul></div><div><ul><li>Exceptional verbal and written communication skills with a proven ability to influence and align stakeholders across all levels and functions within a complex matrix environment, including both internal and external partners. </li></ul></div><div><ul><li>Keen sense for value and understanding of investment strategy, ability to apply risk-balanced and differential investment principles to enhance CMC operations and drive organizational success </li></ul></div></div><div><div><ul><li>Capable of thinking critically and developing strategic plans that align with long-term business objectives and drive innovation. </li></ul></div><div><ul><li>Ability to manage ambiguity and make decisions with limited information, when required. </li></ul></div><div><ul><li>Demonstrated ability to operate as an enterprise leader, driving clarity and influence to advance business objectives </li></ul></div><div><ul><li>Broad understanding of chemical and/or biological, formulation and analytical development and a proven track record in CMC development and/or leading CMC teams throughout the development lifecycle, from early-stage development through commercialization. </li></ul></div><div><ul><li>Experience in multiple modalities (e.g., biologics, small molecules, antibody-drug conjugates) is a clear plus. </li></ul></div><div><ul><li>Relevant strategic and tactical project leadership experience, ability to lead empowered, highly collaborative matrix teams with shared vision, value, and purpose </li></ul></div><div><ul><li>Embraces BMS shared values of passion, innovation, urgency, accountability, inclusion, and integrity </li></ul></div><div> </div></div></div></div>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.<div><div><div><div><div><div><div><div><div><div><div><div><div><div>Compensation Overview:</div></div></div></div></div></div></div></div></div></div></div></div></div></div>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 <a href="https://careers.bms.com/life-at-bms/" target="_blank"> https://careers.bms.com/life-at-bms/.</a> 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:<ul><li>Health Coverage: Medical, pharmacy, dental, and vision care.</li><li>Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).</li><li>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.</li></ul>Work-life benefits include:Paid Time Off<ul><li>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)</li><li>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</li></ul>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 ProtocolBMS 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 shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.

For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.Supporting People with DisabilitiesBMS 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 <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>.

Visit <a href="https://careers.bms.com/eeo-accessibility" target="_blank">careers.bms.com/</a><a href="https://careers.bms.com/eeo-accessibility" target="_blank">eeo</a><a href="https://careers.bms.com/eeo-accessibility" target="_blank">-accessibility</a> to access our complete Equal Employment Opportunity statement.Candidate RightsBMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: <a href="https://careers.bms.com/california-residents/" target="_blank">https://careers.bms.com/california-residents/</a>Data ProtectionWe will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at <a href="http://careers.bms.com/fraud-protection" target="_blank">https://careers.bms.com/fraud-protection</a>.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at <a href="mailto:TAEnablement@bms.com" target="_blank">TAEnablement@bms.com</a>.

Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response.

Inquiries related to the status of your application should be directed to Chat with Ripley.R1604331 : Senior Director, CMC Team Leader

Originally posted by RayzeBio. View original posting

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