Lead Manufacturing Scientist

Lead Manufacturing Scientist

Quotient Sciences

Alnwick, United Kingdom

The Role

We are currently looking to hire a Lead Manufacturing Scientist on a permanent basis. The role will be co-ordinating and managing scientists and technicians involved in the dispensing, manufacture and supply of oral and intravenous clinical products in accordance with GMP requirements and company procedures.

Main tasks and responsibilities

  • Apply scientific expertise and experience to the manufacture and supply of intravenous and oral products for human use.
  • Prepare, review and approve, documentation associated with the manufacture and supply of clinical products.
  • Guide and develop other team members of the GMP manufacturing team to ensure that products of the correct quality are manufactured and documented in compliance with relevant regulatory requirements, internal policies/procedures and client needs.
  • Dispense APIs, excipients, drug products, IMPs and packaging materials for clinical use and maintain GMP stocks as required.
  • Work with formulation development scientists to transfer developed formulations/process’ to final clinical products.
  • Lead the cleaning, maintenance, validation and upkeep of the GMP manufacturing facility, utilities and equipment.
  • Lead clients and colleagues on GMP standards to be applied during product manufacture.
  • Manage the GMP material inventory including goods receipt, storage and stock control, liaising as appropriate with the Quality Control and Microbiology Team.
  • Support the conduct of internal, client and regulatory agency audits of the GMP product manufacturing capabilities.
  • Work with due regards to health and safety of self and others.
  • Work flexibly across the site to meet business needs.
  • Line management.

Experience and skills

  • BSc (hons) or equivalent in a relevant scientific subject.
  • Extensive knowledge and experience of pharmaceutical manufacturing.
  • Good awareness of the current GMP regulatory environment.
  • Knowledge of the drug development process.
  • Experience in guiding professional or technical staff.
  • Good written and oral communication skills.
  • Have a flexible approach to new work challenges.

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