ASSOCIATE DIRECTOR, GMS STABILITY at Bristol-Myers Squibb

Devens, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

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
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 stability requirements

Responsibilities

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 filing dossiers for post-approval filings, and stability related responses to health authority inquiries
Approves the stability sections of filing 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’ inspections internal and external
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

Skills

Key technologies and capabilities for this role

Stability ProgramsLarge MoleculesDrug SubstancesDrug ProductsRegulatory FilingsStability ReportsProduct CommercializationPost-Approval ChangesTeam LeadershipStability Sample Management

Questions & Answers

Common questions about this position

What benefits does Bristol Myers Squibb offer?

Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals at work and in their personal lives.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What are the key responsibilities of the Associate Director Stability role?

The role involves oversight of stability programs for commercial large molecules Drug Substances and Drug Products, leading a high-performance technical team, providing technical expertise, supporting regulatory filings, and handling investigations related to stability issues.

What is the company culture like at Bristol Myers Squibb?

The culture emphasizes challenging, meaningful, and life-changing work with high-achieving teams, growth opportunities, balance, flexibility, and fostering company culture through leadership.

What leadership skills are needed for this position?

Strong leadership skills are required to lead the team, focus on pipeline complexities to achieve milestones, provide technical oversight, mentorship, and coaching.

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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