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Senior Manager

2 months ago

Summit, United States Bristol Myers Squibb Company Full time

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.

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.

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.

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 an inclusive culture, promoting diversity 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 a diverse 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 adastaffingsupport@bms.com . 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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.