Drug Product Development Biologics & CGT
Posted on Apr 5, 2022 by Michael Bailey Associates - UK Contracts
A major Pharmaceutical company is searching for a: Associate Expert in Formulation & Process Development - Drug Product Development Biologics & CGT
To develop client's growing pipeline of products they are looking for a motivated scientist in the area of Drug Product Development Biologics & CGT. As a member of the team, you will play a key role in supporting the development of formulations and processes for parenteral dosage forms for proteins from early phase for clinical supply to commercial use.
- Plan, organize, perform and document scientific experiments as lab scientist under moderate supervision and in collaboration with drug product functional leads, drug product project leads and other team members.
- Support development of phase appropriate liquid of lyophilized formulations for biologics, eg by using high-throughput methods for biophysical characterization and standard drug product specific analytical methods.
- Support development of efficient and robust processes for the manufacture in sterile facilities, eg by applying down-scale models for critical process steps.
- Provide raw data, evaluation and results interpretation for advanced but established methods or procedures. Review and verify raw data generated by others.
- Write protocols, reports or lab procedures based on templates under moderate supervision
- Recognize, communicate and provide input to the solution of problems (eg deviations or unexpected results from experiments); address and solve complex problems within own area of responsibility
- Contribute to maintenance of infrastructure/equipment. Contribute to the evaluation of new lab equipment. Contribute to development of new methods or optimize existing methods
- Actively participate in project teams/meetings/networks
- Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISEC & clients guidelines
. Fluency in English required (oral & written)
. M.Sc. or BSc in Biotechnology, Biochemistry, Biochemical Engineering, Pharmaceutical Sciences or a related discipline or Apprenticeship in industry (or equivalent technical education) with 3 years relevant experience in industry or equivalent
. Awareness for safe handling of chemicals, potentially dangerous materials and equipment.
. Adequate theoretical and scientific knowledge of parenteral dosage forms
. Good practical knowledge of laboratory and/or technical equipment
. Adequate knowledge of software and computer tools.
. Good documentation skills
. Basic presentation skills
. Experience with parenteral dosage forms, protein formulation and analytics, and experience with aseptic working techniques and process development is a plus
. Working knowledge of various data analysis and visualization tools (JMP, Spotfire etc.) is a plus
Michael Bailey International is acting as an Employment Business in relation to this vacancy.