Job Description:
R&D Organic Chemist
The successful candidate will have knowledge and expertise in the safe handling and development of highly potent APIs.
Key Responsibilities:
1. Lead development projects in the high containment laboratory, including route scouting and development, proof-of-concept studies, crystallisation optimisation, and process safety assessments.
2. Identify and implement new technologies to support development for business needs.
3. Collaborate with Operations engineers to ensure successful implementation of laboratory-developed processes in the manufacturing plant.
4. Work with R&D project leads, project management group, and other functions to deliver project milestones on HPAPI projects.
5. Ensure project documentation and campaign readiness activities are completed on time.
6. Collaborate with project engineering and R&D team to manufacture batches in the GMP kilo lab facility.
7. Improve containment practices in R&D and high potency handling plant areas.
8. Participate in cross-functional manufacturing campaign performance support teams and project teams.
9. Lead optimization projects on throughput and yield in collaboration with Operations engineers.
Requirements:
* Technical know-how on handling of complex APIs or Hi-potency APIs (HPAPIs).
* Experience in a GMP kilo lab in the pharmaceutical industry of 5 years or more.
* PhD in organic chemistry or chemical engineering and 5 years practical lab experience.
* Technical know-how on development of Antibody Drug Conjugates (ADC) linker payload complex APIs or Hi-potency APIs (HPAPIs).
* Significant experience in the manufacture or development of linker payloads.
* Subject matter expert on the scale-up of Chromatography, freeze drying, nano filtration, and Tangential flow filtration.
* Strong interpersonal and communication skills and demonstrated ability to work across a matrix.
Additional Requirements: Experience in project management, troubleshooting, and equipment installation, as well as demonstrated capability in root cause analysis and statistical tools.