Senior Analytical Development Analyst

Job Title: Senior Analytical Development Analyst

Location: Middlesex

Duration: ASAP - 12 months contract

The Client: Medium sized pharmaceutical company specializing in the development, licensing and marketing of niche generic medicines and proprietary brands in the UK and across Europe

Benefits: Competitive Salary and benefits available - Full details available on application

The Role:

Analytical method development for assay, impurities, residual solvents tests of solid, liquid, semisolid and other dosage form using HPLC and GC as per the ICH guidelines.
Analytical method validation protocol preparation and its execution.
Analytical method validation data compilation and final report preparation.
Dissolution method development for solid dosage form and its validation as per ICH guidelines.
Dissolution profiling of in-house & innovator products as per bioequivalence guidelines and report preparation
Impurity profiling of in-house & innovator products and report preparation.
To conduct stability studies of different dosage forms as per predefined protocol, data compilation and evaluation as per ICH guidelines.
Analytical method transfer protocol preparation and its execution.
Using different HPLCs software (Empower, chemstation, chemlaunch etc).
Theoretical and practical knowledge of various analytical techniques such as HPLC, GC, GC-HS, IC, dissolution, FT-IR, UV, KF titrator, viscometer, MS, XRD, Prep. HPLC, NMR, DSC, TGA etc.
To conduct excipients compatibility studies for different formulation and its interpretation.
Analysis of finished products as per the specification, MOA and data compilation.

Full details available on application

The Candidate:

Must hold a Masters qualification in Analytical Chemistry
Must have a minimum of three years of previous experience of working within an analytical method development role.
Previous experience of method validation for different drug products.
Previous experience of dealing with validation protocols.
Previous experience in dissolutions in method development and analysis.
Keeping up to date knowledge of cGLP, cGMP, eCTD (section 3.2.S and 3.2.P) and other pharmaceutical guidelines i.e. MHRA, ICH, EMEA.
Strong IT skills (proficient in MS Office: Word, Excel and Outlook).
Extremely organised to deal with a variety of projects and able to prioritise conflicting demands.
High level of accuracy and good attention to detail.
Ability to work under pressure with multiple projects to strict on-going deadlines.
Excellent communication skills (oral and written) and interpersonal skills.

Application Details:

If your skillset is relevant for this role, please click to apply on the link below. However, if this role doesn't suit your current skill-set, please call Alex on for further advice.

Candidates must provide confirmation that they have valid and existing permission to live and work in the UK.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment process.

About Apex: Apex International are an honest, knowledgeable and niche agency who recruit for the pharmaceutical, biotech and CRO sectors in the UK and EU. We specialise in the areas of: Medical Information, Medical Affairs, Pharmacovigilance, Drug Safety, Regulatory Affairs, Clinical Research, QA & QC, Clinical Data Management, Health Economics, Marketing and Pharmacy (Pharmacists, Pharmacy Technicians and Dispensers). For a confidential and professional chat about your job requirements with an agency who are expert in the fields they recruit for, and for the chance to register for free and receive weekly job updates, please call on or email

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