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ASSOCIATE DIRECTOR, GMS STABILITY
ASSOCIATE DIRECTOR, GMS STABILITYMassachusetts Staffing • Devens, MA, US
ASSOCIATE DIRECTOR, GMS STABILITY

ASSOCIATE DIRECTOR, GMS STABILITY

Massachusetts Staffing • Devens, MA, US
5 hours ago
Job type
  • Full-time
Job description

Associate Director Stability

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.

The Associate Director Stability is responsible for the 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 include :

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

Leadership skills include :

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

  • 10 years of relevant work experience required, preferably in a pharmaceutical environment.
  • 2 years' experience as a 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).
  • 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 adastaffingsupport@bms.com .

    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 : https : / / careers.bms.com / california-residents /

    Data Protection

    We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https : / / careers.bms.

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    Associate Director • Devens, MA, US

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