Associate Director - Analytical Development

Location
Abingdon
Salary
£50000 to £80000 per annum
Posted
21 Mar 2019
Closes
18 Apr 2019
Ref
J5631069
Contact
Chris Sowden
Contract Type
Permanent
Hours
Full Time
Hyper Recruitment Solutions are currently looking for a Associate Director - Analytical Development to join a leading Pharmaceutical company based in the Oxfordshire area. As the Associate Director - Analytical Development you will be responsible for ensuring effective Analytical Operations are conducted across the business with the aim of advancing pharmaceutical products to clinical trial phase and eventual commercialisation.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Associate Director - Analytical Development will be varied however the key duties and responsibilities are as follows:

1. You will serve as a subject matter expert for a variety of Analytical Techniques (HPLC, GC, MS and NMR) you will set and justify drug substance/product specifications, retest periods, storage and shipping conditions. You will provide scientific expertise to advance compounds to the clinic (Phase I, II, III).

2. The Associate Director of Analytical Development will take the lead on Method Development, Validation and Transfer Activities, and supervise other team members conducting these tasks, as well as developing effective in-process control methods.

3. Design stability studies for drug substance and drug product, and develop, review and approve documents for regulatory submissions.

4. You will be the focal point for contact with project and other technical teams as well as outsourced service providers, (CMO's and CRO's). You will need to apply a thorough understanding of chemical, solid state and formulation development as it applies to small molecule pharmaceutical products.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Associate Director - Analytical Development we are looking to identify the following on your profile and past history:

1. Relevant degree in Chemistry or related discipline with significant experience working in the Pharmaceutical Industry.

2. Proven industry experience in Analytical Techniques (HPLC, GC, MS, and/or NMR) and the drug development process as it applies to small molecule pharmaceuticals, and leading an Analytical Development Team.

3. A working knowledge and practical experience with ICH, FDA and USP guidelines is essential, including the ability to apply the guidelines in context of the stage of pharmaceutical development

Key Words: / Analytical Team Leader / Analytical Scientist / Lead Analytical Scientist / HPLC / UPLC / GCMS / Method Development / Method Validation / SOP's / ICH / GMP/ Pharmaceutical / Pharma / Chemist / Scientist / Analytical / Research and Development / ICH / cGMP / Tech Transfer / Product Development / Analytical Development / Solid Dose / Oral Solid / Pharmaceuticals / Analytical Director / Head of Analytical / Analytical Services Manager / USP / CMO / CRO / Clinical Trials / Phase I / Phase II / Phase III.

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties 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 professionals and scientists. We look forward to helping you with your next career moves.