Process Development Scientist
Join a company that’s making a difference in the fight against cancer. Astex Pharmaceuticals, www.astx.com, is dedicated to the discovery and development of novel small molecule therapeutics with a focus on oncology. Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan. We are looking for an experienced and motivated professional interested in applying their unique skills to our shared mission. This position will be based in our office located in Pleasanton, California near the Dublin-Pleasanton BART station in the Rosewood Commons campus: http://www.rosewoodcommons.com/transformation.html
We’re looking for a knowledgeable and creative Process Development Scientist to join our Process Chemistry team. The right candidate will be part of a dynamic team that supports the process development activities pertaining to the research, development and scaleup of Active Pharmaceutical Ingredients (APIs).
The Process Development Scientist is responsible for the experiments leading up to the IND and NDA filing of new chemical entities. The candidate will be responsible for the design and conduct of experimentation for the development of new synthetic routes and optimization of existing synthetic routes for APIs leading to scalable processes.
The Process Development Scientist will be responsible for the planning, execution and documentation of all project related experimentation and the evaluation of the corresponding results, as well as collaboration with project leaders in other departments to ensure project timelines are adhered to.
You will be part of the Chemistry and CMC teams responsible for development of the GMP process at the Contract Manufacturing Organizations and will have visibility into the Chemical Development and Regulatory strategy.
- Identify, prioritize and evaluate potential routes of synthesis of target molecules.
- Identify, prepare and characterize impurities and degradation products.
- Conduct spiking experiments in support of pre-validation studies.
- Perform crystallization studies on intermediates or final APIs.
- Provide guidance and support to analytical and drug product departments.
- Manage all support tasks required to maintain a functioning chemical laboratory, for example ordering chemicals, supplies, organizing waste disposal.
- Prepare and follow standard operating procedures.
- Be a leader in the establishment of safe and efficient work practices.
- Write experimental protocols and technical reports capturing details of the experiments conducted and conclusions drawn. Write progress reports and give presentations at the weekly project meetings. Maintain laboratory notebooks for all experimental work performed.
- A Ph.D. degree in Organic Chemistry is required for this role.
- 2-5 years post graduate experience as a synthetic chemist. Experience in the pharmaceutical industry is preferred.
- Proven track record in conducting scientific research, with highly developed problem solving and decision-making skills.
- Established publication record is required, and authorship of patents is a plus.
- Excellent verbal and written communication skills.
- Proficiency in computer applications, including MS Office and SciFinder would be a strong asset.