A growing pharmaceutical company requires an experienced Process Development Scientist. Your role will be to design, lead and implement process development, tech transfer and scale up operations. You must have significant experience in the process development of semi-solid materials.
- Design, lead and disseminate information from process development studies.
- Design, lead and implement tech transfer and scale up operations.
- Devise process experiments and have a working knowledge of Quality By Design.
- Working knowledge of the training requirements set out in EUDRALEX Volume 4 and 2003/94/EC and application of these regulations to company training policies and procedures.
- Develop a working knowledge of GXP systems and procedures including validation of equipment.
- Prepare GxP documentation. Batch records, Quality documents, validation protocols etc.
- Be responsible for planning own work and projects with study directors
- Supervision and training of junior members of staff
- Maintain a level of continuous personal improvement to in order to build the business and the organisation.
- To provide support to the Head of Process Development and Production
- To be sufficiently trained to undertake GMP activities on request – production related activities
- To perform any other tasks requested by senior management.
- Chemistry, Chemical engineering degree
- Ideally 7-10 years in industry and within a process development/late stage formulation department.
- Good communication skills, both written and verbal.
- Proven problem solving skills.
- Coaching and mentoring skills desirable.
- Strong familiarity with DoE and QBD.
- Experience of Process Development of semi solid materials – understands effective mixing and scale up requirements.
- Formulation development background ideal.
- Rheology skills essential.
- Six sigma experience advantageous.
- Demonstrated leadership of tech transfer desirable.
Job Ref: 5466