​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.

Responsibilities:

• 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
  equipment.

• 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
  objectives.

Requirements:

• 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 ewan.rennison@mantellassociates.com