Bristol-Myers Squibb Company

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.

Our 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 execute 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 through 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.

Role & Responsibilities:

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.

Required Competencies:

Technical Expertise:

• In-depth knowledge of cleaning verification and validation principles, methodologies and best practices.
• Familiarity with pharmaceutical manufacturing processes and equipment, including reactors, mixers, blenders, and filling lines.
• Understanding of analytical techniques used in cleaning verification, such as HPLC, TOC, and swab sampling.

Regulatory Knowledge:

• Comprehensive understanding of regulatory requirements and guidelines related to cleaning verification (e.g., FDA, EMA, ICH Q7, Q9, Q10).
• Ability to interpret and apply regulatory standards to ensure compliance in cleaning processes.

Problem-Solving Skills:

• Strong analytical and critical thinking skills to identify, investigate, and resolve cleaning related issues.
• Ability to conduct root cause analysis and implement corrective and preventive actions (CAPA).

Project Management:

• Experience in managing cleaning verification projects, including planning, execution, and documentation.
• Ability to adapt to change, prioritize tasks, manage timelines, and coordinate with cross functional teams to achieve project goals.

Communication and Collaboration:

• Excellent written and verbal communication skills to effectively convey technical information and provide training.
• Strong interpersonal skills to collaborate with colleagues across different departments and levels of the organization.

Attention to Detail:

• High level of attention to detail to ensure accuracy and completeness in cleaning verification documentation and procedures.
• Ability to meticulously review and analyze data to ensure compliance with established criteria.

Continuous Improvement:

• Commitment to continuous improvement and staying updated with industry advancements and best practices.
• Ability to identify opportunities for process optimization and implement improvements in cleaning verification procedures.
• Able to influence teams and seek opportunities to develop new and different ways to resolve project challenges.

Qualifications & Experience:

• Bachelors degree in analytical chemistry, organic chemistry, biochemistry, pharmacy or related field with 9+ years relevant industrial experience or equivalent, or Masters degree and 6-9 years of experience, or PhD and 4-6 years of experience
• Extensive pharmaceutical equipment cleaning verification knowledge and experience
• Demonstrated knowledge of the IND and NDA validation and troubleshooting of chromatographic separation methods used to analyze API and drug product.
• Excellent interpersonal communication skills with capability of interfacing with multidisciplinaryteams.
• Experience with notebook review and regulatory submissions.
• Demonstrate a strong knowledge of cGMP compliance, regulatory agency requirements and ICH compliance.

The starting compensation for this job at the Principal Scientist level is a range from $124,520 - $150,900, 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 our BMS Career Site.

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 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.

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If 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 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.

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility 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: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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