-
Job Description
Senior Process Chemist role requires expertise in process development and technical support for commercial production.
As a key member of the team, you will be responsible for providing process chemistry support for existing and new processes, ensuring the site's scientific, quality, and safety metrics are achieved.
Key responsibilities include:
- Acquiring and maintaining a detailed knowledge and understanding of the chemistry of relevant processes
- Leading/participating in detailed technical risk assessments for plant changes/product introduction
- Contributing to development initiatives to improve process understanding, process control, process capability, cycle time, yield, and efficiency
- Participating in the Technology Transfer process to ensure processes/technologies are suitable for commercial production
- Preparing technical documentation to support manufacturing, including manufacturing batch records, laboratory SOPs, process steps, and technical training material
- Providing training to Operations team personnel
- Leading and seeking approval for process changes and ensuring communication and progression on and off-site
- Investigating quality and yield issues and ensuring deviation reports/unplanned change notifications and Quality Investigation Reports are closed out in a timely fashion
- Liaising with customers to ensure customer issues are addressed, including project updates and specific customer requests
- Supporting laboratory development projects on schedule for relevant processes
- Liaising with procurement to support procurement cost reduction and security of supply projects
- Providing scientific advice to the evaluation and assessment of suppliers
- Providing technical support for Capital engineering projects relating to new products, existing products, and major process re-development
- Supporting submissions for first file, post-approval submissions, annual reports, and internal and external audits
- Maintaining all aspects of Product Quality Lifecycle Management
As a Senior Process Chemist, you will be recognized as the principal point of contact for all technical aspects of a product, accountable at site level and with clients for maintaining knowledge, and maintaining accountability throughout the product lifecycle.
Candidate requirements:
- PhD in Organic Chemistry or related area
- Ideal 3+ years experience in process development, tech transfers, and NPI support
- Experience in supporting API plant processes is helpful