This vacancy is now closed

Head of Process R&D - API Manufacturing - Kent

Scientific and Drug Discovery - Other
Ref: 1061 Date Posted: Friday 03 Aug 2018
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Head of Process R&D – API Manufacturing

Entrust are currently supporting an impressive, growing science led business who are focused on delivering a comprehensive platform of services to clients requiring innovative science-based solutions.

The role is offered on a full time permanent basis and is based on the Kent area.

Our client is looking to enhance their client services and are developing an existing small-scale manufacturing facility and associated analytical functions to deliver active pharmaceutical ingredient (API) products that are compliant with GMP.

Within this role you will be involved in commissioning of the existing facility to meet with regulatory and industry requirements.  Subsequently to lead my clients PR&D GMP facility and team to enable safe and efficient preparation of small molecule drug substance (API) to multi-kilograms scale.

The Head of Process R&D will effectively guide a scientific team on chemistry and career development through leadership, personnel development and ensure training on technical and scientific topics, regulatory issues and relevance of GMP to the area.

General Responsibilities:

  • Delivery of safe, robust, scalable and cost effective synthetic routes supporting GMP and non-GMP campaigns
  • Line management experience including a demonstrated ability to effectively lead and manage a scientific team
  • Have overall responsibility for all drug substance (API) activities, running and maintenance of the cGMP kilo-lab
  • In partnership with quality, develop and approve cGMP documents including, but not limited to, master validation plans, SOPs, protocols and forms
  • Manage, support and evaluate external strategic alliance partners
  • Writing and reviewing documents for INDs / regulatory section submissions
  • Provide technical opinions and recommendations to the members of the process development team in order to elaborate chemical manufacturing processes that are safe, economical and in compliance with cGMP requirements
  • Work with clients for an efficient transfer and implementation of the technical and analytical information
  • Provide validation expertise for issue resolutions to support deviations or CAPAs and audit findings

Ideally you will have a strong background in the following:

  • PhD in pharmaceutics, chemistry or related field with substantial amount of experience in cGMP setting
  • Experience in supply chain management and working with Quality Management Systems (e.g. Deviations, CAPAs, change management)
  • Proven experience in GMP requirements associated with API manufacturing
  • Proven experience in hosting/supporting regulatory inspections and customer audits
  • Excellent organisational and interpersonal skills
  • Excellent oral and written communication skills to produce clear and concise factual findings and ability to present effectively to all levels of the organisation
  • Exceptional interpersonal skills to collaborate with and direct work of others on assigned projects

My client offers:

  • A great working environment
  • Great Career Progression
  • Market Leading Staff Salary
  • Outstanding Company Benefits  

If you are interested in discussing things further then please contact me on 01224 608988 or email suzi@entrustpeople.co.uk

Entrust People are a specialist European life sciences resourcing partner who is dedicated to finding the best talent in the niche disciplines which our business supports.