Laboratory Manager, (Solid state characterisation)

Location
Brighton, East Sussex
Salary
Unspecified
Posted
20 Jan 2021
Closes
19 Feb 2021
Contract Type
Permanent
Hours
Full Time

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.