Senior Associate Scientist, Microbiology-Data Reviewer

Company: Disability Solutions
Location: Indianapolis
Posted on: October 2, 2024

Job Description:

Working with UsChallenging. 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: .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 seeking applicants for a Data Reviewer to support the review of laboratory data generated from microbiological testing and environmental monitoring. Reporting to the Assistant Manager of Microbiology, this role supports the production of targeted alpha therapy (TAT) radiopharmaceuticals at the RayzeBio Indianapolis manufacturing facility. We are seeking a detail-oriented individual who will work closely with lab personnel, quality assurance, and other cross-functional teams to ensure accuracy, completeness, and timely review of data to support the release of products and environmental monitoring trend reports.*This is an onsite position located at Rayzebio's Indianapolis, IN site*Key Responsibilities:

• Review data from microbiological testing of finished products, in-process samples, raw materials, and environmental monitoring (air, surface, and personnel)
• Ensure all data complies with GMP regulations, radiation safety guidelines, and quality standards
• Verify that test results are within acceptable limits and properly documented, including deviations, out of specifications (OOS), and out-of-trend (OOT) events
• Identify and address discrepancies in test results and documentation by working closely with the laboratory and QA teams to ensure corrective actions are taken
• Perform trend analysis of environmental monitoring data and escalate issues to management as necessary
• Ensure data integrity and compliance with electronic data management systems
• Collaborate with internal and external auditors during data integrity audits and inspections
• Support and provide technical, quality, and/or safety information pertaining to environmental monitoring tests to lab management on routine basis
• Support investigations of environmental excursions to identify root causes and implement corrective actions as required
• Proactively identify opportunities for improvements to the data review and investigation processes
• Perform other duties as required by management
• Extended hours or weekend work based on radiopharmaceutical manufacturing schedule may be requiredEducation & Experience:
  • BS in biology, microbiology, or other life science-related 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 required.
  • Experience with sterile manufacturing and/or radiopharmaceuticals preferred.
  • Experience tracking maintenance of laboratory equipment preferred.Skills & Qualifications:
    • Highly motivated with the ability to work independently, without direction, or with others in a team environment
    • Ability to multi-task and prioritize work based on multiple workflows
    • Ability to handle hazardous materials safely
    • Good organizational practices 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
    • Excellent professional ethics, integrity, and ability to maintain confidential information.#RayzebioIf 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 CareersWith 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 . Visit 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: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Disability Solutions, Bloomington , Senior Associate Scientist, Microbiology-Data Reviewer, Other , Indianapolis, Indiana