Key Responsibilities:

  • Lead, develop and implement scientifically sound and fit for purpose validation standards and procedures based on current regulations, industry standards and industry best practices for cell therapy.
  • Create, maintain, deploy global cell therapy validation technical standards via quality system.
  • Promote innovative and efficient approaches to validation incorporating risk-based elements and considerations unique to cell therapy production.
  • Lead, develop and implement the master validation plans for process, equipment, and facilities, in collaboration with the validation and technical SME network.
  • Serve as global consultant for update and revision of exiting site validation master plans.
  • Develop and guide process validation, qualification and process monitoring strategies and framework.
  • Guide the teams to storyboard and present cell therapy global validation framework, standards, and approaches during major health authority inspections.
  • Ensure timely technical support for validation related questions for routine manufacturing, lifecycle process changes, quality audits and health authority inspections.
  • Provide oversight via review and approval of network site level deliverables, including Validation Master Plans, process validation protocols, impact assessments and risk assessments.
  • Author and review CMC summaries of validation for worldwide regulatory submissions for initialization and life-cycle changes.
  • Design qualification strategies to support novel applications of fill, filtration, sterilization and single-use disposable technologies.
  • Facilitate cell therapy harmonization for existing manufacturing sites and adoption of industry best practices.
  • Work with process development and analytical development to ensure early pipeline assets have a robust process for future validation when in pivotal trials.

Qualifications & Experience:

  • B.S/MS.S/Ph. D in Chemical Engineering or Life Science
  • 12+ years of relevant experience in the biopharmaceutical company with most of that experience demonstrating progression of leadership responsibilities and scope.
  • Previous experience should be a combination of technical operation functions such as manufacturing, quality, MS&T or Technical Development.
  • At least 10 years of direct experience in GMP environment is necessary.
  • The leader should have the ability to define the right processes for the team's maturity level, balancing agility and discipline.
  • Career track record and industry reputation should be competitive at the highest level among industry peers.
  • Leader should have demonstrated skill to lead large, complex technical organizations with global scope and build people, processes, and technology in a growing organization. In particular, recruiting and developing strong technical talent in these diverse areas of scope mentioned above will be a key consideration.
  • Strong leadership track record especially in the areas of leading in a global and matrix environment, working cross functionally and developing strong technical talent.
  • Leader should have excellent communication skills and be able to strategically influence the direction of the company in the scope areas mentioned above.
  • This leader will exemplify strong leadership values and be an internal and external facing ambassador of the company in the stated areas of scope in this function.
  • Experience leading regulatory inspections regarding validation and extensive knowledge of regulations, current industry practices, and experience with interpretation and application of guidelines and regulations.
  • Experience with Quality Management System.
  • 2-3 years of experience in cell therapy process development and or manufacturing preferred.
  • Combination of experience in process development, MSAT and quality, experience with manufacturing automation systems/platform, preferred.

Organization Bristol-Myers Squibb
Industry Management Jobs
Occupational Category Director
Job Location Washington,USA
Shift Type Morning
Job Type Full Time
Gender No Preference
Career Level Intermediate
Experience 2 Years
Posted at 2024-07-10 3:29 pm
Expires on 2024-08-24