Laboratory Manager, (Solid state characterisation)

Laboratory Manager, (Solid state characterisation)

This is an exciting time to join us, Custom Pharma Services (CPS) has begun a £20 million program of investment in state-of-the-art facilities for product development and commercial supply of OSD products. The new facilities are designed to formulate and supply high potency products within a new 70,000 sq. ft. facility in Brighton, Sussex.

As part of our growth plans, we are looking for a senior scientist with experience of solid-state characterisation with API’s and intermediates or material science of organic substances gained in the pharmaceutical industry in either a commercial or research & development environment. Reporting into the Head of Laboratory Operations, you will play a key role in developing and establishing this new area of business as well as managing the day-to-day activities of the Development Team.

Company Description

About Custom

CPS is a full-service “Clinical to Commercial” CDMO and holds various licences to operate a range of services which includes MIA, MIA(IMP), MS, WDA(H), API and ManA.  CPS is an independent OSD specialist pharma contract services provider. CPS produces a range of formulations including modified release and potent products such as hormones at low dose. New development and commercial manufacturing facilities for high potency contained processing are under construction at a site adjacent to our existing Brighton, Moulsecoomb packaging and QC facilities. 

About the role

In summary the role includes:

• Ensuring all development activities are established, performed and reported to meet customer, company and statutory /regulatory requirements by effective management of the Development Team.

• Identifying and prioritising Quality Control support requirements and ensuring they are executed in a timely, organised and complete manner to bring about improvement and analytical efficiency.

• Ensuring applicable quality systems are defined, established, maintained and effectively monitored to identify and close gaps (adverse trends). In order to achieve site quality objectives and meet company /statutory regulatory requirements.

• Participating in and allocating resources to ensure all analytical development/support activities are sustained and reported with ongoing activities to mitigate identified gaps or adverse trends.

• Improving the development/ support group processes and adherence to customer quality requirements by applying principles of GMP.

About You

Qualifications, knowledge, skills & experience required:

• Degree level qualifications in Chemistry or closely related Science discipline

• Ideally PhD or 1st class degree qualification.

• Strong chemistry background with previous experience working as a Development Analyst.

• Previous experience within a QC or development environment in the pharmaceutical industry.

• Experience of solid-state chemistry or materials science of organic substances.

• Analytical validation experience.

• Stability studies experience.

• A thorough understanding of Good Manufacturing Practice.

• A familiarity with laboratory equipment/ techniques/ procedures and documentation systems.

• An understanding of EU and other specific analytical regulations for the pharmaceutical industry.

• Experience with Polymorphism screening, Salt screening/Cocrystal screening/Polymorph screening, Pre-formulation evaluation/ Solid Form selection, Crystallisation development.

• Experience suitable for clinical manufacture within a cGMP environment at scale

• Solid Form characterisation Skills / Experience.

• Experience in solid-state/materials science.

• Knowledge of crystallisation processes.

• Knowledge of solid form screening.

• Knowledge of XRPD, DSC, IR, TGA, NMR and GVS.

• Ability to network and communicate well as part of a larger diverse team.

• Ability to lead and develop a team.

• A working knowledge of cGMP.

• High level of Literacy and numeracy.

• Competence in the use of oral and written presentation skills

• Competent in Microsoft Word and Excel.

• Ability to work in a fast-paced commercial environment.

Benefits include: Holiday; pension; life assurance; subsidised gym and annual profit related company and individual bonus payment based on successful performance.

How to apply

Please submit your application including a covering letter explaining how your skills and experience meet requirements of the role

Relocation assistance will be offered to candidates who do not live within commuting distance of Brighton & Hove

No agencies

Applicants must have the right to work in the UK

Successful candidates will be required to complete a basic disclosure check.