As QC Associate, Analytical (ADC), you will have the opportunity to join a group of elite scientists in our new state-of-the-art ADC facility, where you will be responsible for providing laboratory support for High Performance Liquid Chromatography (HPLC) operations, as well as conducting routine HPLC analysis and testing. Support operations include HPLC analysis, data processing and maintenance of instrumentation in our Antibody Drug Conjugates (ADC) operations.
• Performs routine HPLC and MS analysis and testing according to Standard Operating Procedures with GMP documentation (in-process, release, and stability).
• Analyzes data and processes data using Chromeleon and MassHunter.
• Prepares mobile phases, solutions, and buffers according to standard operating procedures to support HPLC operations.
• Manages laboratory inventory of raw materials and supplies.
• Maintains instrumentation according to standard operating procedures.
• Maintains lab area including cleaning of benches, biosafety cabinets and shelving.
• Initiates revisions to current SOPs and authors new SOPs based on methodology being transferred.
• Ensure analytical methods are properly validated/qualified as appropriate in compliance with GMP.
• Embodies Althea’s cultural values and aligns daily actions with department goals and company culture.
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Bachelor's Degree in a Life Sciences discipline or equivalent, Analytical Chemistry degree preferred.
• Minimum of four (4) years of experience in a QC laboratory of a GMP regulated manufacturing facility.
• Minimum of 2 years’ experience performing HPLC or Mass Spectrometry analysis.
• Experience with GMP and FDA regulations required.
• Ability to perform testing in a highly accurate and reproducible manner.
• Effective problem-solving/troubleshooting skills.
• Detail oriented with strong written and verbal communication skills.
• Ability to work independently, within prescribed guidelines, or as a team member.
• Demonstrated ability to follow detailed directions in a laboratory environment.
• Proficiency with Chromeleon and MassHunter preferred.
• Experience with quality and stability testing a plus.
• Experience with JMP or LIMS software a plus.
Ajinomoto Althea, Inc., located in San Diego, CA, is a contract development and manufacturing organization that specializes in cGMP manufacturing, analytical development, aseptic filling into vials & syringes, and protein delivery technology for recombinant protein and parenteral products. In a single location, Althea has the experience, expertise, capacity, and flexibility to serve as a strategic partner for drug development and manufacturing needs for early- stage and commercial requirements.
If you meet the requirements above, and would like to apply for this position, please visit our website at www.altheacmo.com and click on the Careers section. Please be sure to note where you saw our ad posting.
We are an EOE dedicated to a diverse work force and Drug Free work environment.
Qualified M/F/D/V candidates are encouraged to apply.