Senior Scientist, Analytical Testing

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:

The successful candidate will be part of the Analytical Regulated Testing GMP team at BMS New Jersey within Analytical Strategy & Operations. The scientist performs analytical method validation and cGMP activities and provides oversight and strategy to support clinical and commercial development for small molecule New Chemical entities and Investigational Medicinal Products.

Role & Responsibilities:

• Follows GMP/GLP guidelines in the acquisition and/or review of data related to method validation and/or testing of release, stability and development materials. May be assigned to guide others in these activities.
• Applies a phase appropriate approach to GMP in laboratory work and documentation.
• May be responsible for coordination of method transfers, testing, management of and acceptance of data acquired by contract laboratories & service providers.
• Operates within and maintains the laboratory in an 'audit ready' status.
• Participates in audits and inspections.
• May contribute to the establishment and implementation of proper corrective actions for findings.
• Prepares, and may approve, reports for methods, validation, and technology transfer.
• Prepares and/or reviews operational procedures, testing protocols/reports and training materials.
• Practice and assist in implementation of best practices associated with laboratory Quality Systems including training, procedures, instrumentation management, and data and records
• management.
• May prepare and/or approves plans and tools for continuous improvement of quality and compliance.
• Identify deviations to quality systems or limits/specifications, and ensures they are addressed in a timely manner.
• Lead and participates in investigations, including the preparation and implementation of corrective actions (CAPAs).
• May prepare responses to questions from regulatory agencies related to an analytical data and procedures.
• 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.

Qualifications & Experience:

• Bachelor's degree in analytical chemistry, organic chemistry, biochemistry, pharmacy or related field with 7+ years relevant industrial experience or equivalent, or Master's degree and 4-6 years of experience, or PhD and 2-4 years of 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 and influencing multi-disciplinary teams.
• Experience with regulatory submissions and interaction with regulatory agency inspectors.
• Demonstrate a strong knowledge of cGMP compliance, regulatory agency requirements and ICH compliance.

Competencies:

• Demonstrates ability to prioritize project responsibilities to meet competing requirements.
• Ability to adapt to change, manage multiple projects effectively meeting timelines.
• Able to influence teams and seek opportunities to develop new and different ways to resolve project challenges.
• Able to identify opportunities and implement solutions to improve efficiency, productivity and quality/compliance.
• Strong verbal and written communication skills to effectively communicate with key partners both internally and externally.

The starting compensation for this job is a range from $109,270 - $132,400, 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 .... 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:

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