Scientist I, Microbiology

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RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving the 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 Scientist I for the QC Microbiology department. Reporting to the Manager of Microbiology, this individual will help support the microbial contamination control and sterility assurance activities for the radiopharmaceuticals produced at the manufacturing facility in Indianapolis. This role will conduct method development and method validation along with day-to-day activities to support commercialization of aseptically produced targeted alpha therapy (TAT) radiopharmaceuticals for RayzeBios clinical and commercial programs.

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

• Mentor and support the training of microbiology and environmental monitoring (EM) associates

• Prepare, review, and update of Standard Operating Procedures and testing protocols required for GMP microbiology operations in accordance with applicable guidelines (e.g. USP, EP, and ICH)

• Support and perform testing for microbial test method development, qualification and validation for bioburden, sterility, and endotoxin testing

• Support review and approval of sample data, results, and other documents that are generated in the microbiology and environmental monitoring lab

• Prepare and review trending reports for microbiology and environmental monitoring data

• Conduct investigations for quality events and environmental excursions, assist in addressing deviations related to microbiology procedures, and assist in implementing CAPAs as needed

• Participate in troubleshooting activities for utility systems and cleanrooms based on trend analysis of environmental monitoring data

• Participate in the daily operations of microbiology department and its various components, maintaining compliance with company, local, state and federal/ISO policies and regulations

• Participate in internal audits and audits conducted by external agencies and Regulatory Authorities to confirm compliance and identify improvement opportunities

• Support and provide technical, quality, and/or safety information pertaining to microbiological and environmental monitoring tests to lab management on a routine basis

• Assist in the implementation of policies and procedures consistent with those of the organization to ensure efficient and safe operation of the unit

• Work with radiation safety team to ensure laboratory compliance with the radiation safety program at the Indianapolis site

• Develop goals to participate in continuous improvement of the QC department and overall facility

• 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.

• BS/MS in Microbiology or relevant scientific field

• 5-10 years experience within a pharmaceutical microbiology testing environment and/or environmental monitoring experience in a cGMP/FDA regulated facility required

• Strong experience with cGMP regulations, ICH guidelines, quality systems, and safety guidelines

• Experience with sterile manufacturing required

• Radiopharmaceutical experience preferred but not required

• Subject matter expert in various microbiological techniques including bioburden, sterility, and endotoxin testing

• Highly motivated and organized individual with the ability to work both independently and in a team environment.

• Ability to multi-task and prioritize work based on multiple workflows.

• Strong written and verbal communication skills required.

• Excellent professional ethics, integrity, and ability to maintain confidential information.

• Work with computer programs, including but not limited to Microsoft Office.

The starting compensation for this job is a range from $105,763 to $128,200 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. 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 Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Years holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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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.

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 a supportive culture, promoting global participation 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 an 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.

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