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 .
O ur Analytical Strategy and Operations team creates transformative medicines of tomorrow based on the cutting - edge science of today. Working within Global Product Development and Supply this team uses state - of - the art technologies to develop, enable and e xecute analytical and CMC strategies that ensure safety, quality and efficacy of life - saving medicines administered to patients in clinical studies. Our team is involved at the earliest stages of Pharmaceutical and Biopharmaceutical product development th rough the successful commercial launch. As a member of our team, you will get the chance to play a pivotal role to positively impact patients’ lives while developing professionally to achieve your own career goals.

POSITION SUMMARY:

We are seeking a highly skilled and experienced Cleaning Verification Subject Matter Expert (SME) to join our team. This position will be part of the Analytical Regulated Testing GMP team at BMS New Brunswick New Jersey within the Analytical Strategy & Operations department. The ideal candidate will have extensive knowledge and expertise in cleaning verification processes for pharmaceutical manufacturing equipment. This role is critical to ensuring compliance with regulatory standards and maintaining the highest levels of cleanliness and safety in our manufacturing operations. The analyst performs pharmaceutical manufacturing equipment cleaning verification cGMP activities, analytical method validation, and provides analytical support for clinical and commercial development for small molecule New Chemical entities and Investigational Medicinal Products.

Primary responsibility will be to support the pharmaceutical manufacturing equipment cleaning verification (CV) activities that includes:

• Development/validation of Total Organic Carbon (TOC) and Liquid Chromatography (HPLC) methods
• Conducting and reviewing CV sample analysis
• Authoring CV method/validation reports and performing change control associated with the method revisions
• Investigate and resolve cleaning-related issues, deviations, and nonconformances.
• Maintenance of TOC/HPLC instruments
• Assess impacts to CV testing as a result of clinical manufacturing and compound permitted daily exposure limit changes
• Collaborate with clinical manufacturing for periodic procedure revisions and assessment of risks

Additional Responsibilities Include:

• Performs analytical cGMP activities and provide technical expertise for evaluation and feedback of methods.
• Ensure compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., cGMP, ICH) related to cleaning verification.
• Provides technical expertise and troubleshooting for technical problems and investigations.
• Collaborate with cross-functional teams, including Quality Assurance, Production, and Engineering, to ensure effective cleaning processes.
• Participates in the preparation and the critically review of regulatory filings including evaluation of data from collaborator labs.
• Stay current with industry trends, advancements, and regulatory changes related to cleaning verification.
• Technology transfer of analytical methods to external BMS partners
• Provides input into audit readiness and expertise for internal and regulatory inspections.
• Effective collaboration and communication with the CMC sub teams to ensure all API and drug product release testing, stability testing and filing requirements meet associated clinical timelines.