Scientist I, Microbiology - Indianapolis, IN
Scientist I, Microbiology - Indianapolis, IN
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$ 96148 - 116500
1 Vacancy
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
Challenging. Meaningful. Life-changing. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. 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.
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.
Job Responsibilities:
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.
Additional Qualifications/Responsibilities
Education and Experience
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
Skills:
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 $96148 to $116500 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.
Employment Type
Full Time
