Scientist I - Method Validation

Bristol Myers Squibb • Indianapolis, IN

10d • Onsite

About The Position

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: careers.bms.com/working-with-us . 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. RayzeBio, a Bristol Myers Squibb company, is looking for a Scientist I – Method Validation at their Indianapolis manufacturing site. The person will be responsible for method development and implementation, method validation, verifications, or transfer, as well as stability testing activities to support product development at the RayzeBio manufacturing site in Indianapolis. The Scientist I – Method Validation will report directly to the Manager of Analytical Development at the Indianapolis site.

Requirements

• B.Sc. or M.Sc. in Analytical Chemistry, Pharmaceutical Sciences, or relevant scientific field
• Minimum 5 years of experience in analytical method development, validation, verification, and transfer in the pharmaceutical or radiopharmaceutical industry.
• Strong knowledge of analytical techniques such as UHPLC, HPLC, GC, TLC, ICP, LC-MS, Gamma Spectrometry, Alpha Spectrometry, and other analytical methods.
• Knowledge of GMP regulations, quality systems, and safety guidelines.
• 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.

Nice To Haves

• Radiopharmaceutical experience preferred but not required.
• Experience with sterile manufacturing and/or radiopharmaceutical preferred but not required.

Responsibilities

• Develop and validate analytical methods for parenteral radiopharmaceutical products according to phase appropriate guidelines, including UHPLC, HPLC, GC, TLC, ICP, LC-MS, Gamma Spectrometry, Alpha Spectrometry, and other techniques as required.
• Participate in method transfer activities from CDMO or internal research facility to QC team, ensuring accuracy and reliability of data.
• Prepare analytical test methods and method validation, verification, and transfer protocols and reports in accordance with applicable guidelines and industry standards (e.g. USP, EP, and ICH).
• Work closely with other teams to ensure timely delivery of analytical results and support product development and commercialization.
• Participate in troubleshooting and investigations of analytical issues, identify root causes, and implement corrective actions.
• Develop and maintain appropriate documentation, including notebooks, protocols, reports, standard operating procedures and associated forms, and data analysis.
• Participate in instrument qualification, calibration, and maintenance activities.
• Ensure compliance with GMP regulations, safety guidelines, and quality standards.
• Work with RSO to ensure laboratory compliance with the radiation safety programs.
• Provide technical support to other teams or business units as required.
• Source and on-board analytical technologies as required.
• Perform other duties as required by management.

Benefits

• 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.
• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Other perks like tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees