GMP Manufacturer of raw materials for the Biotechnology, Pharmaceutical, and Life Sciences Industry is seeking a Process Development Chemist.
o The process and development for on-going and future GMP manufacturing needs as well as explore feasibility projects for pre-GMP campaigns (NCEs, generics, and conjugates).
- This position is responsible for:
o Manufacturing support for existing processes, and technical guidance during customer interactions.
o Help set the stage for the current and future growth
o Participate with Management and Sales in effectively meeting the mission and goals of the Company as a GMP Contract Manufacturer
Duties and Responsibilities
o Conduct process run & optimize to suit the future GMP production
- Provide hands on support and guidance to all PD chemists.
- Interact with client companies and develop programs to integrate their pre-GMP requirements and the Company's in-house cGMP projects.
- Direct & supervise all the activities for PD operation.
- Design the process and direct the scale for the production.
- Approve the chemical process:
o Conduct product failure and in-process test result OOS investigations
- Ensure product is delivered technically & practically.
- Arrange & direct PD job distribution.
- Determine the appropriate equipment used in future manufacturing.
- Determine the appropriate chemicals suitable for future manufacturing.
- Determine the appropriate columns applicable for future manufacturing.
- Participate in interviewing & evaluating employees' performance.
- Perform employee training.
- Monitor safety in the PD areas.
- Participate in problems solving in the Company.
- Ph. D. in peptide field and/or organic chemistry or related area or equivalent is required.