Manager, CMC Documentation

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. 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.Position SummaryThe Manager, Chemistry, Manufacturing, and Controls (CMC) Documentation & Specifications will join our team located in New Brunswick, New Jersey as a technical author of CMC regulatory submissions and specification.The successful candidate excels in organic chemistry, biological sciences, biochemistry, and/or pharmaceutical sciences and has experience in pharma and/or biologics CMC drug substance and/or drug product development.This role will be performed in close collaboration with other groups within Analytical Strategy & Operations as well as the following departments: Chemical Process Development, Biologics Development, Drug Product Development, Portfolio Strategy & Integration, Manufacturing Science & Technology, Clinical Supply Operations, Nonclinical Safety, and Global Regulatory Sciences. Key ResponsibilitiesThis position involves coordinating filing activities, compiling information from scientists, and authoring the CMC sections of regulatory documents (e.g., IND/CTA, NDA/BLA) to support the timely submissions of both investigational and marketing applications for small and large molecules. Responsibilities also include leading specification activities for small molecules and coordinating the assembly of prompt and accurate technical responses to inquiries from global Health Authorities on the CMC sections of regulatory documents. An important component of the role is data verification to ensure high quality regulatory submissions.A successful candidate is expected to author the approved technical documents in accordance with project timelines, proactively identify concerns, and provide feedback to the CMC Development Team on potential issues. This position requires the candidate to use critical analysis and scientific judgment to solve problems and pay scrupulous attention to detail.Qualifications & ExperienceA degree in organic chemistry, biological sciences, biochemistry, and/or pharmaceutical sciences, or related disciplines with a minimum of 5 years of pharmaceutical development experience is preferred. The level of the position may be evaluated against the experience of the candidate. The candidate should have excellent verbal and written communication skills and interpersonal skills. This position requires constructive interactions with other members of a team to approach problem solving. Familiarity with computer-assisted document preparation tools is highly desirable.#LI-OnsiteIf 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.Compensation Overview:New Brunswick - NJ - US: $115,230 - $139,637 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 OffUS 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 holidaysBased 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 manuf