Location: Oxford, Permanent, Full time.

Scancell (https://www.scancell.co.uk/) was founded in 1997 as a spin-out from the University of Nottingham and is developing novel treatments for hard to treat cancers and infectious diseases. It currently employs over twenty staff, with research scientists located in Nottingham and some managerial, development and administrative staff in Oxford. The Company is now expanding into new laboratory facilities on the Oxford Science Park, where activities will focus on support for the Company’s clinical trial activities, and formulation and analytical development activities for its novel products.

Summary of Post

The Drug Product Manager role is a key position with responsibility to lead and manage the outsourced GMP manufacturing operations involved in the production of Scancell’s peptide and plasmid DNA drug products. The post holder will also be involved with the assessment and technical transfer of formulation processes and analytical methods developed in house to GMP facilities and will liaise closely with the Formulation Development and Active Pharmaceutical Ingredient (API) manufacturing teams to ensure an effective delivery of GMP product into the clinic.

Key Roles and Responsibilities

  • Lead the outsourced GMP formulation development, manufacturing and process validation across the company’s drug product portfolio.
  • Develop a deep understanding of the Company’s technology platforms and identify appropriate manufacturing partners and processes to fulfil the clinical supply needs.
  • Liaise with the Company’s API manufacturing and in-house formulation development teams to ensure a smooth transition into final formulation operations and successful scale-up.
  • Prepare Requests for Proposals for competitive bids and quotations, with the appropriate specifications, terms and conditions.
  • Manage Contract Manufacturing Organisations (CMOs) to ensure performance and control over their GMP operations.
  • Monitor GMP compliance by reviewing production batch records and escalating discrepancies to senior management as required.
  • Use process and technical knowledge to lead troubleshooting activities, provide investigations support, analyse process data, and identify/implement process improvements.

Essential requirements

  • BSc required in Biology, Chemistry, Chemical and/or Biomedical Engineering or related scientific discipline.
  • More than 5 years of experience in the biopharmaceutical industry, with at least 3 years in a position directly related to pharmaceutical development and/or manufacturing.
  • Experience, ideally hands-on, with final formulation and fill/finish processes for complex biological entities, preferably with a knowledge of DNA and/or peptide products.
  • Knowledge of analytical techniques used for the characterisation of DNA and peptide products.
  • Proven track record of managing CMOs, including multiple cGMP manufacturing sites.

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to changing business needs.

If you would like to be considered, please send a full C.V. including references, and a detailed covering letter specifying how your particular skills and experience are relevant for this post to: [email protected]

Salary: Competitive salary and comprehensive employee benefits

Closing date: 31 December 2021

Applications from recruitment agencies will not be accepted.