Position Title
Chemistry Quality Control Laboratory Supervisor
Job Description:
Chemistry Supervisor ensures the fundamental integrity of the laboratory infrastructure. This position oversees routine and non-routine analysis of proteins, peptides, small molecules, large molecules, and ADCs, and supports the development of procedures & initiatives to Quality Control departmental goals. This is a 2nd shift opportunity.
Responsibilities:
- Oversees in-process, release, and stability activities for buffers, intermediates, and finished drug product in the QC Chemistry Department.
- Responsible for all applicable QAD input associated with release of finished goods.
- Coordinates QC functions with operation activities and cross departmental staff.
- Ensures implementation and maintenance of quality systems, including but not limited to, SOP writing, deviations, technical report review and personnel training.
- Interacts with clients and follows up on client inquiries. Serves as a liaison between the Company and auditors.
- Oversees quality testing, along with the implementation of new testing methods, including qualification and validation of test methods.
- Analyzes data, technical reports, deviations, OOS investigations and test results and provides conclusions and proposals for future directions; capable of critical review.
- Makes recommendations for corrective action necessary to assure conformity with quality specifications.
Qualifications Desired:
Bachelor’s degree in a Life Sciences discipline with 4 years of relevant experience in quality control or contract laboratory testing and minimum of 1 year of functional or day to day leadership or mentoring experience. Or, a Master’s degree in Life Sciences or Analytical Chemistry with 2 years laboratory experience with ELISA or HPLC and minimum of 1 year of functional or day to day leadership or mentoring experience.
Description of Company:
At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.
Application Instructions:
Please a apply online at https://phe.tbe.taleo.net/phe01/ats/careers/v2/viewRequisition?org=ALTHEATECH&cws=38&rid=1828
About:
At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.