Commercial Specification Committee Chair Director

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.

PRINCIPLE OBJECTIVE OF POSITION Briefly describe the purpose of this position

The Chair of the Commercial Specification Committee (CSC) will focus on the oversight of the CSC, serving the BMS community in the development of robust specification documentation for all portfolio programs from PPQ enabling specifications to the end of commercial lifecycle for both Biologics and Pharmaceuticals. This leadership role requires the candidate to manage a matrix team of subject matter experts while driving continuous improvement of the CSC business processes and associated scientific specification processes throughout the BMS organization. The Director will also work to document best practices, procedures, and guidance in support of the CSC.

MAJOR DUTIES AND RESPONSIBILITIES

State the most important activities and accountabilities of this position. Describe how these activities and accountabilities can influence the achievement of company or business goals.

Chair the Biologics Specification Committee (CSC) to facilitate the technical evaluation of specification documents (Justification of Specification, JoS) by the CSC in support of in-process, release and stability testing of drug substances, drug products, and placebos within the BMS portfolio from PPQ through the end of commercial lifecycle for the Technical Product Teams (TPTs)

Lead the strategic evolution of the CSC by evaluating and incorporating emerging and current industry concepts to improve the technical/scientific aspects of JoS documents/specifications

Lead the business process evolution of the CSC with the use of operational excellence and program management tools

Lead and/or participate in opportunities to build, define and improve associated specification processes that interface with the CSC business or scientific process including the Critical Quality Attributes Council and Integrated Biologics Technical Review forums

Develop templates, standards and/or procedures to support the robust development of a specification document

Document or revise existing documents governing the CSC in directives, SOPs or technical documents to support operations and scientific strategy

Communicate with ATLs/APLs/IDTs/TPTs/CSC members and other stakeholders on an individual and collective basis for the purpose of knowledge sharing and continuous improvement

Evaluate the performance of CSC individuals as a matrix leader of the CSC. Provide feedback, coaching and mentoring to CSC members in addition to performance information to their supervisors. Provide CSC team members and their supervisors CSC year-end metrics.

KNOWLEDGE / SKILL

Describe the type and extend to which knowledge of a specific type is required to perform this job in a satisfactory manner. Where skills can be obtained through formal training / education and experience. List the type and amount of education and experience that would typically prepare an individual for this position.

Education:

PhD in Analytical Chemistry or related scientific disciplines with > 10 yrs. relevant experience

MS or BS with > 15 yrs relevant experience

Minimum of 15 years of experience in biologics development (process development, formulation development, stability, analytics) preferably having broad experience in the analytical analysis of biopharmaceuticals. In addition, experience in small molecule analytics and formulation development is desirable.

Experience / Knowledge Desired:

Broad knowledge and understanding of the overall biologics and small molecule development and commercialization process as applied to the integration of process development, formulation and stability, analytics and CMC-Regulatory to develop a control strategy and specification approvable to Health Authorities

Demonstrated leadership capability to achieve success when working and leading virtual teams in a matrix organization

Experience in the authoring and/or the technical evaluation and approval of biologics and Pharmaceutical JoS documents in the clinical or commercial lifecycle

Experience with the integration of analytical methodologies, critical quality attributes/critical process parameters, and clinical experience toward the development of specifications and/or a control strategy for biopharmaceuticals and pharmaceuticals

Experience in evaluating JoS documents, specifications and/or control strategies for biopharmaceuticals and pharmaceuticals

Demonstrated ability to operate independently and have appropriate judgement to make or facilitate decisions, particularly as related to the justification of specifications

Broad compliance knowledge (cGMP, ICH, FDA/EU guidance, WHO) as it applies to the biopharmaceutical and pharmaceutical landscape for the development of specifications

Demonstrated excellence in developing key stakeholder buy-in

Demonstrated ability to drive performance and achieve results

Demonstrated ability to identify and develop synergies, across functional and business organizational lines that support CSC strategic objectives.

Superior communication, collaboration, relationship management, consensus building, negotiation, analytical and problem-solving skills

Experience in authoring/reviewing of CMC submissions for specifications is highly desired

WORKING CONDITIONS

Describe the extent to which the job must be performed under working conditions that are considered undesirable, potentially hazardous, require travel, or require absence from home overnight.

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