Job Description
Working with Us
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 rich in diversity. 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 is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS. RayzeBio is developing innovative drugs against targets of solid tumors. The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier stage testing for patients with small cell lung cancer (SCLC). Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
RayzeBio, a Bristol Myers Squibb company, is seeking applicants for a Quality Control Data Reviewer. We are seeking a detail-oriented Quality Control Data Reviewer to play a key role in the development and commercialization of RayzeBio's targeted alpha therapy (TAT) radiopharmaceuticals. Ideally, the candidate will have prior laboratory and technical experience in the radiopharmaceutical industry. Additional responsibilities may include documenting and/or conducting laboratory investigations.
- This is an onsite position located at Rayzebio's Indianapolis, IN site*
Key Responsibilities - Review Quality Control data for accuracy, completeness and compliance with established procedures and regulatory requirements.
- Ensure Quality Control data is reviewed in a timely manner.
- Conduct periodic review and updates of Quality Control Standard Operating Procedures, as necessary.
- Conduct Investigations-Lead and conduct in-depth investigations following standard operating procedures for out of specification results and other quality issues in the quality control laboratory.
- Document Findings of investigations-write detailed investigation reports and work with QA and QC management to propose provide corrective action and corrective training to prevent repeat events.
- Ensure data integrity throughout data review and investigations as required.
- Proactively identify opportunities for improvements to both investigations and the data review processes.
- Position is salaried position, generally first shift, 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, biohazardous materials, and hazardous chemicals.
- Up to 10% of travel may be required.
- Other duties as assigned by management.
Education & Experience - BS in Chemistry, Biology, Science, or relevant field with five to seven years of experience in pharmaceutical or other cGMP experience. Advanced degrees may be acceptable with less experience, however direct experience with cGMP technical writing is required.
- Thorough understanding of cGMP regulations, ICH guidelines, FDA and other regulatory process investigation process
- Experience with injectable pharmaceuticals or radiopharmaceuticals strongly preferred.
- Experience tracking maintenance of laboratory equipment preferred.
Skills & Qualifications - Ability to multi-task, and prioritize work based on multiple work-flows is a must
- Ability to handle hazardous materials safely
- Good organizational practices are required
- Strong analytical and problem-solving skills.
- Ability to work well and communicate effectively with multiple stakeholders
- Strong written and oral communication skills
- Work with computer programs, including but not limited to Microsoft Office
- Highly motivated with the ability to work independently, without direction, or with others in a team environment
#Rayzebio 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 //careers.bms.com/california-residents/
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Job Tags
Full time, Remote job, Work alone, Shift work, Weekend work, Day shift,