Senior Manager / Associate Scientific Director, Stability

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 rich in diversity. Take your career farther than you thought possible.

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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.

Title: Senior Manager / Associate Director of Stability

Position Summary:

The Stability Associate Director/Senior Manager is responsible for managing the stability programs for small molecule and biologics development assets from first in human clinical trials to and including commercial registration. The Associate Director/Senior Manager designs stability studies, review data and author documents such as protocols, reports, and stability sections of filings, while also overseeing and guiding the efforts of direct reports.  The Associate Director Level is also responsible for the Stability Operations Group which manages GMP storage chambers and stability sample set up, storage, and delivery.

Role & Responsibilities:

• Prepares or approves stability protocols and reports, insures proper reviews and approval. Make the storage recommendations for label and shelf life of products. Prepares responses to regulatory agency questions. May be assigned to represent BMS in meetings with regulatory agencies.
• Prepares stability sections of regulatory filings.
• Reviews study data and conducts stability data reviews. Performs trend analysis, raises alerts on issues and ensures unexpected results receive appropriate evaluation. May be responsible for management of and acceptance of data acquired by contract laboratories.
• Evaluates and implements changes to practices reflective with changes in regulatory environment and evolving industry best practices.
• Review and approval of records, laboratory notebooks and reports. Sustains practices so that work is audit ready. Participates in audits, prepares responses and corrective actions.
• Responsible for overseeing several direct reports for successful project completion and professional development. Will assist the stability group, as needed, with continuous improvement initiatives.
• May be responsible for the Stability Operations Group

Experience & Qualifications:

• Bachelor's degree or advanced degree with a major in Biology, Chemistry or a related science
• Senior Manager Level: 9-12 years of relevant experience, preferably in a GMP analytical/stability environment.
• Associate Director Level: 12+ years of relevant experience, preferably in a GMP analytical/stability environment.
• Understanding of GMP regulations, company policies and regulatory requirements preferred
• Ability to build strong, trusting relationships, and work across divisions, diverse business backgrounds and cultures.
• Excellent communication and interpersonal skills with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.

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