Product Manufacturing Expert

Updated: February 12, 2018
Job ID: 213651
Status: Full-Time
Regular/Temporary: Regular
Location: Frederick, MD, United States

Come Work at HJF!

The Henry M. Jackson Foundation (HJF) is looking for a Product Manufacturing Expert, to support the US Army Medical Material Development Activity (USAMMDA) in the Product Technical Operations Branch at Ft. Detrick, Maryland.  HJF provides scientific, technical and programmatic support services to USAMMDA.

Responsibilities:

  • Provide SME support for a variety of investigational product development plans and efforts and provide knowledgeable regulatory compliance information relating to GMP, GLP, and GCP
  • Provide commercial sector manufacturing perspective to Principal Investigators, advanced development Product Managers and others as they seek compliance with FDA rules and regulations
  • Consult on the developmental-appropriate scientific and documentation requirements for compliance of facilities/laboratories and associated assays and processes from the sponsor’s perspective 
  • Interact frequently with RA Scientists, Product Managers, Clinical Affairs, Branch Chiefs, Laboratory Directors, Laboratory Technicians, and Quality Assurance representatives
  • Develop and assist with laboratory and manufacturing compliance activities and related documentation to include those related to: product-related assays, product testing, accountability, manufacturing, laboratory, data systems and equipment
  • Facilitate efficient development of the product while ensuring compliance
  • Provide consulting services on product development strategy as it pertains to the extent of compliance needed as a function of the appropriate stage of product development 
  • Share manufacturing and testing related regulatory compliance information with appropriate individuals, teams, and forums to reduce and/or prevent critical errors that may inhibit the development of products.

SKILLS AND EXPERIENCE:

  • At least 20 years of experience in research, manufacturing, non-clinical studies and FDA licensure of investigational products
  • Specialized experience in (1) research protocol development and review, (2) assay development and validation, (3) regulatory compliance for clinical and non-clinical studies, and (3) auditing the performance of Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs)

MINIMUM EDUCATION: Minimum of a Ph.D. or equivalent doctoral degree that included major study in an academic field related to the health sciences or allied sciences appropriate to the work of the position.

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status or other status protected by law.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Director of Human Resources.

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