Senior Scientist - Analytical CMC Strategy

Employer: Bristol Myers Squibb Company
Location: Devens, MA, United States
Start date: Jun 22, 2019

Discipline: Information Technology, Business/Data Analytics, Science/R&D, Biotechnology
Required Education: Doctorate/PHD/MD
Position Type: Full time
Hotbed: Genetown, Best Places to Work

Job Details
Company

Job Details

Summary:The Senior Scientist - Analytical CMC Strategy lead support serves as the point of a contact and contributor for BMS on the strategy & technical leadership for Biological Product assets in the Analytical Science & Technology organization (a member of the Biologics Operations Division). This role requires individual contributions and leadership of a matrix team of analytical scientists supporting commercialized and late-stage biopharmaceutical products with a focus on establishing the analytical CMC strategy, enabling regulatory filings, providing technical partnership for testing laboratories around the world, managing the life cycle of products and specifications (methods and acceptance criteria), and authoring/reviewing responses to health authority questions on commercial products.

Duties/Responsibilities:

This position will be located at the Bristol-Myers Squibb site in Devens, MA. The Senior Scientist will collaborate across BMS sites with Analytical Science and Technology teams, Manufacturing Science and Technology, Analytical Development, Global Quality product leads, technical project teams, and Regulatory leads to generate and execute the commercial strategies for drug substance and drug product methods and specifications, network analytical control strategies, and support of product life cycle regulatory filings.
The Senior Scientist will be responsible for contributing and/or leading a matrix team responsible for preparation of licensure applications, rest of world filings, follow-up measures, and prior approval submissions.
Through strong leadership, the Senior Scientist will ensure the support of analytical methods and analytical change control across the BMS network, for third party manufacturing and our partners at outside testing labs.
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.
- Functions as an individual contributor for analytical activities for late-stage and commercial programs in support of strategic decisions.
- Operates within a matrix analytical team to support during all BLAs, ROW & PAS filings and reviews, 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.
- Coordinates optimization and improvement of analytical program support.
Serves as project expert during inspections

QUALIFICATIONS:

Specific Knowledge, Skills, Abilities, etc:

Demonstrates a broad expertise and knowledge in analytics routinely used for in-process, release and stability testing of Biologics or Protein Therapeutics drug substance and drug product. Experience in product characterization and strategies to stablish process and product knowledge.
Strong communication and leadership skills in a highly interactive environment.
Demonstrated skills in working across-functional strategic teams and collaboration with internal and external partners.
Strong knowledge of biologics CMC regulations and cGMP requirements, as well as, experience in supporting regulatory filings.
Demonstrated participant or lead of matrix teams of scientists and/or project management professionals.

Education/Experience/ Licenses/Certifications:

A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with at least 4, 10 or 13years of industrial experiences in relevant fields, respectively.

Physical Demands

This is primarily a coordination role for a commercial program, including office work, teleconferencing, computer work, and running meetings, as well as working with quality control analysts in a laboratory setting. Including ...
Sitting
Walking-Level Surfaces

Work Environment

This is primarily a coordination role for a commercial program, including office work, teleconferencing, computer work, and running meetings, as well as working with quality control analysts in a laboratory setting. Including ...
Inside Work
Working Alone
Working with/around others
Chemicals

Travel

This position may require approximately 25% travel.

Supervisory Responsibilities

No direct reports (but leading in a matrix organization).

Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

Company info

Website: http://www.bms.com/
Phone: +1-800-332-2056
Location: 430 E. 29th St
14th Floor
New York
New York
10016
United States

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