Bristol Myers Squibb
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. 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, 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.
Summary The Senior Specialist, QA Operations will help support operations through quality oversight in a Radiopharmaceutical facility in Indianapolis, IN. The Senior QA Operations specialist will be providing oversight over shop floor activities in accordance with regulatory standards and RayzeBio procedures. The Senior QA Operations specialist will also be responsible for material and batch disposition activities. This position will utilize quality assurance knowledge in ensuring compliance in operations to support clinical development and GMP commercial operations in accordance with RayzeBio policies, standards, procedures and global current Good Manufacturing Practice (cGMP).
The Senior Specialist provides Quality support and oversight for operations and disposition activities at the Indianapolis facility, including review and approval of Deviations, CAPAs, Change Controls, documents, Batch Records, and Material and Lot Disposition. This person may also interact with the Qualified Person (QP) as needed to facilitate release of EU doses.
Job Responsibilities
Build and maintain cross functional relationships to improve processes and resolve issues.
Provide quality oversight on manufacturing and validation activities.
Perform real time review of manufacturing records.
Perform periodic walkthroughs of manufacturing and Quality Control areas to ensure continued compliance with procedures.
Provide guidance on the handling of quality and shop floor activities.
Support Quality disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations.
Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation.
Identify and report discrepancies from required work practices or procedures to management.
Make sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.
Participate as requested in the response team for audits and inspections by health authorities.
Education and Experience
BS/MS degree in science related field (including biology, biochemistry, chemistry, engineering, or related areas) is preferred
Minimum of 5 years' experience in quality assurance and/or compliance roles in the pharmaceutical industry.
Experience working in a GMP aseptic manufacturing environment preferred.
Experience working with FDA or other regulatory authorities is preferred.
Skills and Qualifications
Expertise in GMP, Quality, material and product disposition
Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principles
Detail-oriented with demonstrated applications in problem solving and decision-making abilities with moderate oversight from management
Team player who can work independently to achieve objectives in a fast-paced environment
Excellent verbal and written communication skills.
Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired.
Knowledge of US, EU and rest-of-world cGMP regulations and guidance.
Knowledge and proven experience in FDA, EMA, or other regulatory authority.
Well-practiced in exercising sound judgment in decision-making.
Demonstrated prioritization and organization skills.
Physical Demands While performing the duties of this job, 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 30 pounds. Specific vision abilities required by this job include close vision and distance vision.
This is a position that requires working in an environment with radioactive materials where protective clothing, gloves, and safety glasses are required.
Work Environment The noise level in the work environment is usually moderate. This position may require work outside of normal working hours or on weekends.
Compensation Overview Indianapolis - RayzeBio - IN: $82,236 - $99,650
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 employee's work schedule, job‑related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Benefits 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 wellbeing 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 Year's 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.
Equal Opportunity Employer Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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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. 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, 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.
Summary The Senior Specialist, QA Operations will help support operations through quality oversight in a Radiopharmaceutical facility in Indianapolis, IN. The Senior QA Operations specialist will be providing oversight over shop floor activities in accordance with regulatory standards and RayzeBio procedures. The Senior QA Operations specialist will also be responsible for material and batch disposition activities. This position will utilize quality assurance knowledge in ensuring compliance in operations to support clinical development and GMP commercial operations in accordance with RayzeBio policies, standards, procedures and global current Good Manufacturing Practice (cGMP).
The Senior Specialist provides Quality support and oversight for operations and disposition activities at the Indianapolis facility, including review and approval of Deviations, CAPAs, Change Controls, documents, Batch Records, and Material and Lot Disposition. This person may also interact with the Qualified Person (QP) as needed to facilitate release of EU doses.
Job Responsibilities
Build and maintain cross functional relationships to improve processes and resolve issues.
Provide quality oversight on manufacturing and validation activities.
Perform real time review of manufacturing records.
Perform periodic walkthroughs of manufacturing and Quality Control areas to ensure continued compliance with procedures.
Provide guidance on the handling of quality and shop floor activities.
Support Quality disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations.
Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation.
Identify and report discrepancies from required work practices or procedures to management.
Make sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.
Participate as requested in the response team for audits and inspections by health authorities.
Education and Experience
BS/MS degree in science related field (including biology, biochemistry, chemistry, engineering, or related areas) is preferred
Minimum of 5 years' experience in quality assurance and/or compliance roles in the pharmaceutical industry.
Experience working in a GMP aseptic manufacturing environment preferred.
Experience working with FDA or other regulatory authorities is preferred.
Skills and Qualifications
Expertise in GMP, Quality, material and product disposition
Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principles
Detail-oriented with demonstrated applications in problem solving and decision-making abilities with moderate oversight from management
Team player who can work independently to achieve objectives in a fast-paced environment
Excellent verbal and written communication skills.
Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired.
Knowledge of US, EU and rest-of-world cGMP regulations and guidance.
Knowledge and proven experience in FDA, EMA, or other regulatory authority.
Well-practiced in exercising sound judgment in decision-making.
Demonstrated prioritization and organization skills.
Physical Demands While performing the duties of this job, 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 30 pounds. Specific vision abilities required by this job include close vision and distance vision.
This is a position that requires working in an environment with radioactive materials where protective clothing, gloves, and safety glasses are required.
Work Environment The noise level in the work environment is usually moderate. This position may require work outside of normal working hours or on weekends.
Compensation Overview Indianapolis - RayzeBio - IN: $82,236 - $99,650
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 employee's work schedule, job‑related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Benefits 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 wellbeing 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 Year's 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.
Equal Opportunity Employer Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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