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RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Summary

The Associate Director 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 proactive Initiatives, 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.   

• Ten plus years of hands-on biologics/sterile experience within a development/operations facility (manufacturing and/or analytical).

• Prior experience in Quality is preferred.

• An equivalent combination of education and experience may be substituted

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).

• 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).

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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.

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 an inclusive culture, promoting diversity 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 a diverse 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.

BMS 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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS 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: https://careers.bms.com/california-residents/

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