Scientist - Method Validation

Scientist I – Method Validation

Location:

Indianapolis, IN

Company:
Bristol Myers Squibb – Rayze Bio, a Bristol Myers Squibb company headquartered in San Diego, CA.

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. Read more:

• 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 (USP, EP, 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, SOPs 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.
• 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.

• 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.
• Radiopharmaceutical experience preferred but not required.

• Experience with sterile manufacturing and/or radiopharmaceutical preferred but not required.
• Advanced instrumentation experience such as Mass Spectrometry, Gamma Spectrometry, or other spectroscopic methods.

• 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.

Regularly required to sit, reach with hands and arms, talk or hear. Occasionally lift and/or move up to 40 pounds. Specific vision abilities required: close vision and distance vision. Workplace involves protective clothing, gloves, and safety glasses while handling radioactive materials.

The noise level in the work environment is usually moderate.

Indianapolis – Rayze Bio – IN: $96,148…