Senior Director Analtyical CMC Strategy

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

The Director of Analytical CMC strategy is accountable for defining and executing the commercial analytical CMC strategy for BMS small and large molecule biopharmaceutical products. In this role the director will lead a team of managers and individual contributors with accountability for establishing and executing the analytical CMC strategy which includes defining CQAs, assessing comparability, defining the analytical control strategy, establishing and maintaining commercial specifications, and defining the regulatory submission strategy. As a member of the Global Quality Analytical Science & Technology organization within the Global Product Development and Supply division, the Senior Director will lead a team of approximately 30 scientists and will establish the analytical lead role in the pharma operating model, striving to standardize ways of working across the large and small molecule organizations.

Duties/Responsibilities:

This position will be located at the Bristol-Myers Squibb site in Devens, MA or Central New Jersey sites. The Senior Director will collaborate across BMS sites and across the GPS enterprise with analytical development, global quality product leads, global brand leads, technical project teams, and regulatory leads to generate and execute the commercial CMC strategies for drug substance, active pharmaceutical ingredients, and drug products. Accountability for the analytical CMC strategy throughout the product lifecycle is a key component of this role, and requires fostering strong partnerships across the GPS organization.

The Senior Director will be accountable for leading a matrix team responsible for preparation of licensure applications, rest of world filings, follow-up measures, and prior approval submissions.

Additional responsibilities include:

– Create and maintain effective partnerships with stakeholders from analytical development, manufacturing sciences and technology, Supply Chain, Regulatory, Quality, Process Sciences, Drug Product Development, Project Management, and Manufacturing to deliver analytical strategies with a high probability of technical and regulatory success.

-Capture, communicate and mitigate risks associated with manufacturing capability and regulatory approval.

– Supervise the management of analytical activities for late-stage and commercial programs.

– Lead effective matrix analytical support during all BLAs, ROW & PAS filing review and works with analytical development in supporting the responses to FUMs and PMCs.

– Co-leads the effort to implement effective control strategy, analytical method and specification change control as needed throughout the BMS network, third party manufacturing and outside testing labs.

– Coordinate optimization and improvement of analytical program support.

-Serve as project expert during inspections

QUALIFICATIONS:

Specific Knowledge, Skills, Abilities, etc:

Strong communication and leadership skills in a highly interactive, fast-paced environment.

Ability to build effective teams and identify opportunities to standardize and harmonize ways of working where relevant.

Proven ability to transform cultures and create a compelling vision for change.

Demonstrated skills in leading cross-functional strategic teams and collaborating with internal and external partners.

Comprehensive knowledge of biologics and small molecule CMC regulations and cGMP requirements, as well as, experience in supporting regulatory filings.

Demonstrated leader of matrix teams of scientists and/or project management professionals.

Demonstrates a working knowledge in analytics routinely used for in-process, release and stability testing of Biologics and/or small molecule biopharmaceuticals.

Demonstrated ability to develop technical and strategic leadership talent to meet current and future business needs

Strong ability to analyze complex issues, assess risk, devise strategies aligned with business imperatives and translate strategies into action

Education/Experience/ Licenses/Certifications:

– A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with at least 15 years of biopharma experience in relevant fields.

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com