Senior Manager of CMC - Quality Assurance Indianapolis - RayzeBio - IN R1603587 Posted 16 hours ago
$141.52k - $171.48kBristol-Myers Squibb
- # Senior Manager of CMC - Quality AssuranceIndianapolis - RayzeBio - INFind out how well you match with this jobAt RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: Senior Manager of Chemistry, Manufacturing & Controls (CMC) - Quality Assurance develops and drives Quality (manufacturing and analytical) strategies for CMC activities (drug substance, API, drug product, and analytics) for compounds in Development (radiopharmaceuticals). The emphasis of the position will be at the Indianapolis manufacturing facility and therefore, the incumbent must be located at the site. The incumbent will be responsible for multiple projects, which may be at the Indianapolis site, San Diego, and/or CMOs.**Job Responsibilities**Essential duties and responsibilities include the following. Other duties may be assigned.* Member of CMC Development Teams providing Quality (QA) input from pre-clinical to end of product life cycle, including NDA filing, other market filings, and post approval changes. Partners with technical SMEs to develop and approve the CMC strategy (DS, DP, and analytical strategy) for new drug candidates.* Responsible for change control management, for compound/product-specific changes, through the product lifecycle to include impact assessments, tracking, and implementation. Also, as appropriate and compound/product specific, responsible Quality member for oversight and QA approver of all key Quality System deliverables associated with the drug development candidate including, Deviations, Investigations, CAPAs, and Complaints.* Review and approve compound/product specific analytical method life cycle documents (e.g., API and bulk drug product specifications, analytical test methods (including micro), and protocols/reports); including stability.* Work with CMC Teams to conduct compound/product specific risk assessments, as required, for all aspects of the drug development process. Responsible for communicating Quality risks within the Quality organization.* Collaborate with Regulatory to track/own Quality input for ongoing regulatory filings and updates to Health Authorities (e.g. IND/IMPD/BLA/NDA) including specifications, shelf-life extensions, country specific trial approvals, etc.* Performs other tasks as assigned (e.g., final Quality reviewer/approver of Quality events and/or GMP documentation, actively contributes to ongoing investigations as required).**Education and Experience*** Minimum of B.S. degree, preferably in Chemistry, Biochemistry, or a similar Scientific field.* Five plus years of hands-on biologics/sterile experience within a development/operations facility -manufacturing and/or analytical. (An equivalent combination of education and experience may be substituted)**Preferred Education and Experience*** Prior experience in Quality**Skills and Qualifications*** Thorough knowledge of the Pharmaceutical Development processes as evidenced by bringing multiple INDs through to successful BLA/NDA approval. Knowledge of bulk biologic drug substance (monoclonal antibody, bispecific, etc.), parenteral (cold chain liquid/lyophilized form) drug product, cell/gene therapy product process development/manufacturing, and/or development/manufacturing of radiopharmaceuticals is required.* Recognized as a CMC expert, radiopharmaceuticals and/or biologics, with an ability to introduce best practices into the quality management systems.* Thorough understanding of cGMPs and regulatory requirements (e.g., FDA, EU, ICH).* Well-versed in relevant CMC area, with an ability to introduce Quality-relevant (phase appropriate) best practices into the CMC development processes.* Excellent investigational and QA problem-solving skills. Analytical mindset, with an ability to assess new situations to define and implement the appropriate QA action plan.* Ability to work independently, yet effectively in a team environment.* Superior attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.* Teamwork oriented with the ability to work effectively across functional groups and teams to ensure requirements are met (e.g., early phase, late phase, regulatory).* Applies AI to improve team execution and decision‐making* Other proven competencies such as strategic thinker, influencer and negotiator are required.* Continuous improvement mindset is also required.**Physical Demands**While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision. This is a position that requires working in a GMP cleanroom environment, wearing protective clothing, and handling of radioactive materials.**Work Environment**The noise level in the work environment is usually moderate. Work-related travel (outside of Indianapolis, Indiana) may be required up to 20% of working time (e.g., 10 weeks per year).*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.*******Compensation Overview:******Indianapolis - RayzeBio - IN: $141,515 - $171,483 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 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 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:** *T*he 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.***RayzeBio and Bristol Myers Squibb**RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.**Supporting People with Disabilities**BMS and RayzeBio are 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 View email address on click.appcast.io. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.**Candidate Rights**BMS and RayzeBio 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: Protection**We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at 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 View email address on click.appcast.io. 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.R1603587 : Senior Manager of CMC - Quality Assurance
- J-18808-Ljbffr Bristol-Myers Squibb
Vacancy posted 4 days ago
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