Director of Process Technology

Posted 02 April 2023
LocationUnited States of America
Job type Full Time
Contact NameEwan Rennison

Job description

Mantell Associates are currently partnered with a market leading US organisation on their search for a Director of Process Technology to be part of the leadership team.


  • Process Development: Directs all process development, including the establishment of
    development requirements for new products and continually reviews and reports on the
    progress of new processes built in accordance with cGMP requirements.

  • Technology Transfer: Directs all technology transfer activities. This includes the
    transition of materials from discovery to commercial manufacturing, including scale-up
    activities and technology transfer reports.

  • Equipment Selection & Validations: Manages the selection of equipment and final
    decision on process workflow to ensure controlled manufacturing of BioSpectra products
    meeting established and approved specifications. Oversees the qualification of all process

  • Product Life Cycle: Ensures that all annual product reviews are completed in a timely
    manner and in accordance with ICH Q7 GMP guidelines.

  • Leadership: Participates in leadership meetings to establish, delineate, and review
    organizational policies, to coordinate functions and operations between departments and
    company locations, and to establish responsibilities and procedures for attaining


  • Bachelor of Science degree in Chemistry, Bio-Chemistry or other related field of science
    and/or equivalent relevant experience.

  • A minimum of ten years of related experience in process development, technology
    transfer, process validations and equipment qualifications.

  • The ideal candidate will have a deep working knowledge of process development of
    chemical materials such as excipients, buffers, and small molecule active pharmaceutical
    ingredients, or other similar materials, in support of the bio-pharmaceutical industry.

  • The ideal candidate will have an effective working knowledge of process development,
    process validation, cleaning validation, equipment qualification, and cGMP requirements,
    and all applicable regulatory and industry standards

If you'd like to find out more please reach out to Ewan Rennison on +44 203 854 7700 or