Manager, Analytical Development

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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 radiopharmaceutical.

RayzeBio, a Bristol Myers Squibb company, is looking for a Manager, Analytical Development at their Indianapolis manufacturing site. The person will be responsible for method development/implementation, method validation/transfer, special studies to support product development as well as stability testing activities if needed. The Manager, Analytical Development will report directly to the director of analytical chemistry at the Indianapolis site.  

Job Responsibilities:
Essential duties and responsibilities include the following.  Other duties may be assigned.
•    Develop a comprehensive roadmap and strategic plan to guide analytical development activities from Investigational New Drug (IND) stages through to commercialization. This includes designing and implementing phase-appropriate analytical methods, ensuring compliance with regulatory requirements, and aligning with product development timelines. 
•    Collaborate cross-functionally to support method development, validation, transfer, and lifecycle management to ensure robust and scalable analytical processes for successful product launch and commercial supply.
•    Mentor and lead a team of scientists in the development, evaluation and implementation of analytical procedures relevant to product characterization and qualification testing.
•    Oversee and participate in developing, optimizing and validating analytical methods for raw materials and injectable radiopharmaceutical products according to phase appropriate and compendial guidelines, including HPLC, GC, TLC, ICP, and other techniques as required.
•    Participate in method transfer activities from CMO or internal research facility to QC team, ensuring accuracy and reliability of data.
•    Design and lead special studies such as forced degradation, in-use stability, compatibility studies etc. as needed, to support new drug filings and regulatory submissions.
•    Prepare and review appropriate documentation, including Standard Operating Procedures, analytical test methods and method validation/transfer protocols and reports, data analysis, risk assessment, and related procedures in accordance with applicable guidelines (e.g. USP, EP, and ICH).
•    Participate in troubleshooting and investigations of analytical issues, identify root causes, and implement corrective actions.
•    Participate as needed in instrument qualification, calibration, and maintenance activities.
•    Work with RSO to ensure compliance with established radiation safety programs.
•    Perform other duties as required by management.
•    The position is salaried.  Work will be predominantly first shift, M-F, but extended hours or weekend work based on radiopharmaceutical manufacturing schedule may be required.  
•    This position will require the applicant to work with and around ionizing radiation and hazardous chemicals.

Education and Experience

·      BS degree with 10 years of experience, Master’s degree with 8 years or PhD with 6 years of  industrial experience of industrial experience in analytical method development, validation, and transfer within the pharmaceutical industry to support product development.  

·       A minimum of 2 years of experience in a management role, overseeing analytical development teams and projects

·       Demonstrated hands-on experience in analytical techniques, such as HPLC, GC, TLC, ICP-MS

·       Strong experience with cGMP regulations, ICH guidelines, quality systems, and safety guidelines

Preferred Experience:
•    Experience with sterile manufacturing and/or radiopharmaceutical

Skills: 

•    Proficient in the use of laboratory instrumentation and Microsoft Office Suite
•    Highly motivated and organized professional with the ability to work independently or in a team environment
•    Strong analytical and problem-solving skills
•    Ability to multi-task and prioritize work based on multiple workflows
•    Ability to communicate effectively with multiple stakeholders
•    Strong written and oral communication skills
•    Excellent professional ethics, integrity, and ability to maintain confidential information.

#RayzeBio

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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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