Associate Director, Biologics Analytical Compliance
Location:
Posted:
October 20, 2016
Reference:
1604384
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.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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.

The Associate Director in Biologics Analytical Compliance will focus on the oversight of the Biologics Specification Committee (BSC), serving the BMS biologics community in the development of robust specification documentation from preclinical through commercial lifecycle. This leadership role requires the candidate to manage a matrix team of subject matter experts while driving continuous improvement of the BSC business processes and associated specification processes throughout the BMS biologics organization. The Associate Director will also work to document best practices, procedures, and guidance in an appropriate manner in support of the BSC and other compliance efforts in the department.

  • Chair the Biologics Specification Committee (BSC) to facilitate the technical evaluation of specification documents by the BSC in support of the release and stability testing of drug substances and drug products within the BMS biologics portfolio from preclinical through commercial lifecycle for the Integrated Development Teams (IDTs) and the Technical Product Teams (TPTs)
  • Lead the strategic evolution of the Biologics Specification Committee by improving business processes and evaluating the technical/scientific aspects of specifications
  • Lead and/or participate in opportunities to build or define associated specification processes that interface with the BSC business or scientific process
  • Develop and document templates, standards and procedures to support the robust development of a specification document in an appropriate technical and/or standard operating procedure format
  • Contribute to the development of a quality system framework for the management of reference materials and critical reagents through partnering with clinical and commercial analytical development organizations
  • Contribute to the development of an analytical compliance standard through partnering with the clinical and commercial analytical organizations to support the analytical lifecycle


Qualifications:
Qualifications
  • BS/BA in a life science field, advanced degree preferred
  • Minimum of 10 years of experience in biologics development, preferably having a strong background in the analytical analysis of biopharmaceuticals
  • Broad knowledge and understanding of the biologics development process as applied to the integration of process development, formulation and stability, and analytics to develop a specification
  • Demonstrated leadership capability to achieve success when working and leading virtual teams in a matrix organization
  • Demonstrated ability to operate independently and have appropriate judgement to make or facilitate decisions, particularly as related to the BSC
  • Broad compliance knowledge (cGMP, ICH, FDA/EU guidance, WHO) as it applies to the biopharmaceutical landscape for the development of various quality system frameworks
  • Success in undefined or ambiguous environments
  • 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 BSC strategic objectives.
  • Superior communication, relationship management, negotiation, analytical and problem-solving skills
  • This role can sit at other US based BMS sites.
A little about us:
Our shared focus to become a Diversified Specialty BioPharma company is driving us forward. Pioneering in new areas of research.

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