ASSOCIATE DIRECTOR, GMS 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. 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 .


The Associate Director Stability is responsible for stability product strategy and oversight of product stability programs for commercial large molecules Drug Substances and Drug Products. Activities include those associated with product stability strategy, stability program requirements, stability sample management, preparation, review and approval of stability reports and regulatory filings.


The Associate Director is responsible for leading high-performance technical team, developing team and fostering company culture.


Responsibilities

• The Associate Director Stability is accountable for the stability commercial program for large molecules Drug Substances and Drug Products.
• Accountable for new products commercialization and providing support to the sites or external manufacturing for new products commercialization.
• Serves as stability representative on project teams covering post-approval changes, designs and executes required premarket stability program in support of the change.
• Accountable for the handling of annual commercial stability program for assigned products in coordination with sample management group.
• Provides technical expertise to the stability team.
• Provides support for authoring stability sections of filling dossiers for post-approval filings, and stability related responses to health authority inquiries.
• Approves the stability sections of filling dossiers, annual reports, product renewals, Annual Product Stability Reviews.
• Provide support for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues or capacity issues.
• Accountable for stability procedures and ensures consistency with site department and BMS groups procedures.
• Leads OpEx initiatives to streamline and standardize management of stability programs.
• Supports health authorities' inspection internal and external.

Leadership skills:

• Leads the team and focus on the pipeline complexities to achieve milestones and objectives, while providing technical oversight, mentorship, and coaching.
• Leads with a global mind-set to direct and influence multiple remote teams
• Drives sense of team responsibility for group's success, promoting a high commitment to business goals and objectives
• Accountable for stability resources definition and budget.
• Fosters a culture focused on demonstrating high capacity for executing with company values and behaviors.
• Provides continuing development opportunities, including ongoing performance assessments

Qualification:

• 10 years of relevant work experience required, preferably in a pharmaceutical environment.
• 2 years' experience as team manager.
• Expert knowledge and understanding of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility.
• Expert Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices.
• Expert Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods.
• Significant Experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality management principles.
• Excellent skills to drive development of technical or scientific initiatives for solving complex problems/issues, recommending and drive science-based decisions/ implementation of solutions.
• Significant experience on health authorities' inspections in front room.
• Excellent written and verbal communication skills.
• Leadership experience: Team, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation.
• Advanced knowledge of Microsoft office applications, LIMS, Quality Management system (e.g. TrackWise or Veeva), Statistics software (e.g. SlimSTAT, JMP).
• #LI-ONSITE

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.



Compensation Overview:


Devens - MA - US: $168,930 - $204,702
New Brunswick - NJ - US: $157,880 - $191,312


The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.


Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit


Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.



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 a supportive culture, promoting global participation 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 an 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.



Supporting People with Disabilities


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 [email protected] . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.



Candidate Rights


BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.


If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:



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