Analytical Scientist - Method Validation

Bristol Myers Squibb•Indianapolis, IN

1d•Onsite

About The Position

At RayzeBio, a Bristol Myers Squibb company, we are seeking an Analytical Scientist for our Indianapolis manufacturing site. This role is crucial for supporting product development by being responsible for method development and implementation, method validation, verifications, or transfer, as well as stability testing activities. You will join a multidisciplinary team focused on developing transformative radiopharmaceutical therapies for cancer patients, blending the spirit of a biotech with the resources of a global leader.

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.
Prior extensive experience with ICP-MS, including verifying USP<232>/<233> or ICHQ3D(R2) Elemental Impurities and developing and validating custom ICP-MS methods for dozens of elemental impurities that may be present in raw materials.
Prior experience composing or collaborating on Elemental Impurities risk assessments.
Prior experience in a GMP pharmaceutical testing laboratory with 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

Experience with parenteral drugs and/or radiopharmaceutical preferred but not required.
Experience with ICP-MS, including verifying USP<232>/<233> Elemental Impurities and developing and validating ICP-MS methods for dozens of elemental impurities that may be present in raw materials.

Responsibilities

Develop and validate analytical methods on an Inductively Coupled Plasma Mass Spectrometry instrument (ICP-MS) for testing Elemental Impurities present in parenteral radiopharmaceutical drugs and raw materials.
Collaborate on the development and validation of other methods utilizing alpha spectrometers, gamma spectrometers, mass spectrometers, and ultra-high-performance chromatography.
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).
Develop and maintain appropriate documentation, including notebooks, protocols, reports, standard operating procedures and associated forms, and data analysis.
Participate in troubleshooting and investigations of analytical issues, identify root causes, and implement corrective actions.
Participate in instrument qualification, calibration, and maintenance activities.
Work closely with other teams to ensure timely delivery of analytical results and support product development and commercialization.
Participate in method transfer activities from CDMO or internal research facility to QC team, ensuring accuracy and reliability of data.
Provide technical support to other teams or business units as required.
Ensure compliance with GMP regulations, safety guidelines, and quality standards.
Work with RSO to ensure laboratory compliance with the radiation safety programs.
Source and on-board analytical technologies as required.
Perform other duties as required by management.

Benefits

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
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.
Flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)) for US Exempt Employees.
160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays for Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees.
Unlimited paid sick time (based on eligibility).
Up to 2 paid volunteer days per year (based on eligibility).
Summer hours flexibility (based on eligibility and role).
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs.
Annual Global Shutdown between Christmas and New Years Day.