Principal Scientist/Senior Principal 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 Brunswick New Jersey within the Analytical Strategy & Operations department. The scientist performs/oversees analytical method validation, cGMP activities and provides analytical support for clinical and commercial development for small molecule New Chemical entities and Investigational Medicinal Products.

Role & Responsibilities:

• Performs analytical cGMP test activities and provide technical expertise for evaluation and feedback of methods.
• Provides technical expertise and troubleshooting for technical problems and investigations.
• Participates in the preparation and the critically review of regulatory filings including evaluation of data from collaborator labs.
• 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.

Experience & Qualifications:

• Principal Scientist Level: 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
• Senior Principal Scientist Level: Bachelors degree in analytical chemistry, organic chemistry, biochemistry, pharmacy or related field with 12+ years relevant industrial experience or equivalent, or Masters degree and 9-12 years of experience, or PhD and 6-8 years of experience
• Advanced degree (MS or PhD) are preferred but not mandatory.
• Demonstrate knowledge of the IND and NDA validation and troubleshooting of chromatographic separation methods used to analyze API and drug product.
• Experience with GMP testing and notebook review.
• Demonstrate a strong knowledge of cGMP compliance, regulatory agency requirements, ICH guidance.

Competencies:

• Ability to adapt to change, manage multiple projects effectively meeting timeline