• Job Title: Technical Project Manager
• Location: Hove, East Sussex (good transport links)
• Experience in Solid Dose Formulation, Development and Manufacturing Processes ESSENTIAL
• Technical scientific background and project management skills from a GMP-compliant Pharmaceutical environment are ESSENTIAL
• Scientific qualification ESSENTIAL (ideally Chemistry)
• Excellent communication / delegation skills ESSENTIAL
• Permanent role with salary range £30k - £45k depending on experience

Summary

A brand new opportunity for a Technical Project Manager who has strong knowledge of solid dose formulation / manufacturing, stability studies, method development / validation, regulatory compliance, pharmacovigilance, raw material sourcing and other technical services, to join an ambitious third party company on the South Coast.

The Company

An independent UK-based contract organisation, providing manufacturing, packaging and technical services to a variety of leading Pharmaceutical companies. In addition to the production of tablets and capsules, they offer a number of technical services to large and small Pharmaceutical companies. These services include:

 Formulation / Troubleshooting
 Process Optimisation
 Method Development / Validation
 Stability studies
 Product Testing for EU Entry
 Regulatory compliance
 EU Gateway QP release to market
 Supplier and API GMP auditing
 Annual product quality reviews (APQR’s)
 Raw material sourcing
 Due Diligence evaluations
 Analytical services (HPLC, UV, FTIR, Karl Fischer, Specific Optical Rotation etc)

With around 200 employees over 2 sites, the company has a strong reputation for its efficiency and buzzing atmosphere.

The Role

Using your range of skills to the full, you will lead a variety of technical projects as per the demands of your Pharmaceutical clients. Working in a small team, you will set out project plans, allocate resources, work out timescales / budgets and delegate duties to the on-site Development Technicians. You will investigate and optimise processes to assist the production of tablets, granules and capsules.

You will manage technology transfer of products into the company, write SOPs, ensure full compliance with GMP, write technical reports, prepare master documentation for the pilot plant / production areas and QC and be the main client contact (this will involve some client visits on other sites).

From a Regulatory perspective, you will submit new licence applications and post approval variations to regulatory authorities and communicate with the MHRA / FDA regarding MA (Marketing Authorisation) licences. You will also respond to Medical Information enquiries and process Adverse Events, directly inputting into PSURs.

This is a broad, challenging role that requires multiple skills and the ability to handle several projects at once.

Benefits

• 23 Days' holiday
• Pension
• Private Health Cover

Experience

You must have relevant experience from a similar environment, with proven project management skills and a strong background in chemistry (or similar) and outsourceable technical services.

Keywords

Chemist, technical project manager, stability, method development, validation, regulatory, PSUR, MHRA, FDA, MVP, VMP, HPLC, UV, IR, Karl Fischer, project management

SLS Services Ltd operates & advertises as an Employment Agency for permanent positions and as an Employment Business for contract/temporary positions.