Assistant 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 pharmaceutical manufacturing equipment cleaning verification activities, 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:

• Primary responsibility will be to support the pharmaceutical manufacturing equipment cleaning verification (CV) activities that include development/validation of Total Organic Carbon (TOC) and Liquid Chromatography (HPLC) methods, conducting and reviewing CV sample analysis, and maintenance of TOC/HPLC instruments.
• 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.
• Practice and assist in implementation of best practices associated with laboratory Quality Systems including training, procedures, instrumentation management, and data and records management.
• May conduct and participate in investigations, including the preparation and implementation of corrective actions (CAPAs).
• Identify deviations to quality systems or limits/specifications, and ensure they are addressed in a timely manner.
• Prepares and/or reviews operational procedures, testing protocols/reports and training materials.
• Operates within and maintains the laboratory in an ‘audit ready’ status. Participates in audits and inspections

Experience & Qualifications:

• BS degree in analytical chemistry, organic chemistry, biochemistry or Pharmacy with 0-3 years relevant experience
• Advanced degree (MS) is preferred but not mandatory.
• Pharmaceutical equipment cleaning verification knowledge
• LCMS and GC techniques are a plus
• 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 multi-disciplinary teams.
• Demonstrate a strong knowledge of cGMP compliance, regulatory agency requirements and ICH compliance.
• Ability to adapt to change, manage multiple projects effectively meeting timelines.
• 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.
• Able to influence teams and seek opportunities to develop new and different ways to resolve project challenges.