CMC Senior ManagerDublin
Our client is an exciting clinical stage drug discovery and development company working on new medicines to improve the quality of life for people with rare and inflammatory diseases. This highly innovative biopharmaceutical company, focused on discovering and developing new therapeutics, is looking for a CMC Senior Manager with a strong technical background in Product Process Development & Formulation. This individual will lead on the provision of Chemistry, Manufacturing and Control (CMC) services on all Company Development Projects.
Management of CMC activities at contract research organisations/contract manufacturing organisations (CRO/CMO) including process development, formulation development, analytical support, quality & audit oversight and clinical supply.
Management of product development activities across the portfolio including, drug substance and product characterisation, formulation and process development, analytical method development/validation and packaging activities
Management of process scale-up and process validation as required.
Advise on clinical and commercial product supply chains.
Compilation and review of documentation to support clinical trial Investigational New Drug (IND) and/or Investigational Medicinal Product Dossier (IMPD) submissions in line with Company’s business strategy and timelines.
Attending and supporting project meetings and Agency meetings.
Science degree in a relevant discipline, masters or PhD level a distinct advantage (Process Development or Formulation Scientist with trouble-shooting experience) and at least 7 years’ experience working in a GMP environment within a Biotechnology or Pharmaceutical company.
Knowledge of drug formulation and optimization of dosage forms is desirable.
Experience of preparation and review of CMC technical reports, CMC dossier sections and Drug Master Files.
Training on management of CRO/CMOs can be provided to the successful candidate.
Cv to email@example.com / 00 353 (0) 1 2302400/ www.rftgroup.ie