Head of Process R&D - Active Pharmaceutical Ingredients

Location
Kent
Salary
Generous and competitive
Posted
02 Aug 2018
Closes
30 Aug 2018
Ref
J56370
Contact
Eve Hegarty
Contract Type
Permanent
Hours
Full Time
We currently representing a client in their search for a Head of Process R&D to join their expanding facility in Kent area. Our client supports drug discovery, research and development to the pharmaceutical and biopharmaceutical sectors, and are currently looking to take advantage and develop a small-scale manufacturing facility and existing analytical facilities to deliver APIs which are compliant with GMP.

As Head of Process R&D you will be responsible for commissioning of the existing facility to meet with regulatory and industry requirements and subsequently to lead our 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.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Head of Process R&D will be varied however the key duties and responsibilities are as follows:

1. Delivery of safe, robust, scalable and cost effective synthetic routes supporting GMP and non-GMP campaigns.

2. Line management experience including a demonstrated ability to effectively lead and manage a scientific team.

3. Have overall responsibility for all drug substance (API) activities, running and maintenance of the cGMP kilo-lab.

4. In partnership with quality , develop and approve cGMP documents including, but not limited to, master validation plans, SOPs, protocols and forms. You will write and review documents for INDs / regulatory section submissions.

5. 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.

6. Effectively hire, develop and train team members

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Head of Process R&D we are looking to identify the following on your profile and past history:

1. PhD or equivalent experience in a chemistry related discipline, plus significant experience working in a cGMP setting. Specifically, you will require experience with GMP requirements associated with API manufacturing.

2. Experience in supply chain management and working with Quality Management Systems (e.g. Deviations, CAPAs, change management). You will also require experience in hosting/supporting regulatory inspections and customer audits.

3. This is a new role within the company, and we are therefore looking for someone who is interested in developing a career within a large organisation.

Key Words: API | Drug substance | Active pharmaceutical ingredient | pharmaceutical | GMP | cGMP | management | manufacturing | process development | R&D

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.

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