API Organic Process Development Specialist
4 days ago
Job Description:
We are seeking a highly skilled API Organic Process Development Specialist to join our team at Cpl Healthcare. The successful candidate will be responsible for supporting projects from early clinical phases through to commercial production.
The ideal candidate will have a strong understanding of GMP requirements for the manufacture of clinical stage projects and experience in the development of HPAPI processes. They will also have excellent problem-solving skills, strong interpersonal and communication skills, and the ability to work effectively in a matrix environment.
Key Responsibilities:
- Support the development of new products from customers
- Develop, complete proof-of-concept studies in the kilo lab, crystallisation isolation, and process safety assessments as required
- Create all required GMP paperwork including Master Batch records for kilo scale materials
- Collaborate with project engineering and R&D team to build the GMP kilo lab facility and bring new technologies on site
- Improve and develop current non-GMP kilo lab offerings
- Run Kilo lab scale GMP manufacture in the GMP kilo lab alongside operations and R&D colleagues
- Work cross-functionally to ensure that project documentation and campaign readiness activities are completed on time
- Actively participate in cross-functional manufacturing campaign performance support teams
- Lead and support quality and safety investigations as required
- Take an active role in the delivery of R&D metrics for safety and quality across all processes and activities operating on site
Requirements:
- Degree in chemistry or chemical engineering
- Min 3 years industry experience in a GMP kilo lab or pilot plant in the pharmaceutical industry
- Regulatory understanding of GMP requirements for the manufacture of clinical stage projects
- Use of glass reactors at kilo lab scale
- Strong interpersonal and communication skills and demonstrated ability to work across a matrix environment
- Excellent problem-solving skills and commitment to continuous improvement
- Ensuring that GMP, Quality, Health & Safety are considered in all aspects of the role
- Demonstrated capability in the use of standard tools for root cause analysis and standard statistical tools
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