Scientist I Method Validation

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profile Job Location:

Indianapolis, IN - USA

profile Monthly Salary: Not Disclosed
Posted on: 30+ days ago
Vacancies: 1 Vacancy

Job Summary

At RayzeBio every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb RayzeBio blends the nimble pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here youll join a multidisciplinary team where your ideas are valued your expertise is amplified and collaboration is at the heart of everything we do. From day one expect to make an immediate impacton our science on our teams and most importantly on patients. Learn more about RayzeBio: 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 manufacturing site in Indianapolis. The Scientist I Method Validation will report directly to the Manager of Analytical Development at the Indianapolis site.

Job Responsibilities:

Essential duties and responsibilities include the following. Other duties may be assigned.

  • 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.

  • 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:

  • . 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.

Preferred Experience:

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

  • Advanced instrumentation experience such as Mass Spectrometry Gamma Spectrometry or other spectroscopic methods.

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.

Physical Demands:

While performing the duties of thisjob 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 40 pounds. Specific vision abilities required by thisjobincludeclose vision and distance vision.

This is a position that requires working in a laboratory environment protective clothing gloves and safety glasses are required while working in a laboratory environment with radioactive materials.

WorkEnvironment:

The noise level in theworkenvironment is usually moderate.

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If you come across a role that intrigues you but doesnt 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.

Compensation Overview:

Indianapolis - RayzeBio - IN: $96148 - $116508

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

  • Health Coverage: Medical pharmacy dental and vision care.

  • Wellbeing Support: Programs such as BMS Well-Being Account BMS Living Life Better and Employee Assistance Programs (EAP).

  • Financial Well-being and Protection: 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.

Work-life benefits include:

Paid Time Off

  • US Exempt Employees: flexible time off (unlimited with manager approval 11 paid national holidays (not applicable to employees in Phoenix AZ Puerto Rico or Rayzebio employees)

  • Phoenix AZ Puerto Rico and Rayzebio Exempt Non-Exempt Hourly Employees: 160 hours annual paid vacation for new hires with manager approval 11 national holidays and 3 optional holidays

Based on eligibility* additional time off for employees may include unlimited paid sick time up to 2 paid volunteer days per year summer hours flexibility leaves of absence for medical personal parental caregiver bereavement and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours depending on the nature of their work and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors leased workers and other service providers are not eligible to participate in the program.

RayzeBio and Bristol Myers Squibb

RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however RayzeBio will continue to operate as a standalone organization.

Supporting People with Disabilities

BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application or in any part of the recruitment process direct your inquiries to. Visit access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS and RayzeBio 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: Protection

We will never request payments financial information or social security numbers during our application or recruitment process. Learn more about protecting yourself at data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way please contact BMS at . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response.

R: Scientist I - Method Validation

Required Experience:

IC

At RayzeBio every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb RayzeBio blends the nimble pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transfor...
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Key Skills

  • Laboratory Experience
  • Immunoassays
  • Machine Learning
  • Biochemistry
  • Assays
  • Research Experience
  • Spectroscopy
  • Research & Development
  • cGMP
  • Cell Culture
  • Molecular Biology
  • Data Analysis Skills

About Company

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Bristol-Myers Squibb is a global biopharmaceutical company focused on discovering, developing and delivering innovative medicines for patients with serious diseases. Our medicines are helping millions of patients around the world in disease areas such as oncology, cardiovascular, immu ... View more

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