Senior Scientist, Analytical Testing

Bristol Myers Squibb•New Brunswick, NJ

1d•Onsite

About The Position

At Bristol Myers Squibb, our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. 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 the 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.

Requirements

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.

Nice To Haves

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.

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.

Benefits

wellbeing support
retirement and financial protection benefits
insurance offerings (medical, dental, vision, life and disability)
Flexible Time Off (FTO)
11 paid company holidays each year
160 hours of paid vacation annually for new hires
3 optional holidays
paid sick leave
up to two paid volunteer days per year
summer hours flexibility
leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
annual Global Shutdown between Christmas Day and New Year's Day