Process Development Scientist
Attractive salary and package
My client is currently looking for a Process Development Scientist to join the Product & Process Development R&D team.
Process Development Scientist required to manage the operation of the R&D, GMP manufacturing pilot plant facility, to support production of Clinical Trial supplies and manufacturing process development activities.
- Day to day management of the GMP manufacturing facility, equipment and utilities and leadership of the manufacturing team.
- Ensure facility, equipment and procedures are maintained in compliance with all internal and external safety, environmental and GMP requirements.
- Delivering equipment, facility and utility capital projects, maintenance and safety programs with appropriate validation.
- Act as a primary manufacturing team leader to plan and execute batches and coach mentor and train staff in new manufacturing techniques.
- Ensuring Safety, Quality, Regulatory and Business facets are prioritised in a manufacturing environment.
- Keeping up-to-date, familiar and complying with all company and regulatory requirements for safety, environmental and GMP best practice.
- Plan organize, schedule and execute manufacturing campaigns.
- Author clear and detailed manufacturing documentation and manage documentation system.
- Contribute to product technical transfer - laboratory to pilot and pilot to full scale manufacture.
- Relevant BSc or equivalent qualifications in a scientific, or manufacturing related discipline.
- Industry experience within pharmaceutical production or Pilot Plant (scale up).
- Experience completing quality documentation processes for GMP manufacturing plant.
- Strong organizational and interpersonal skills.
- Solid project management skills.
- Excellent Problem-solving skills are essential and familiarity with Quality by Design, risk-based approaches to development, design of experiments, and process modelling.
- Demonstrated hands on practical skills gained in a pharmaceutical product manufacturing environment.
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