Bioburden & Endotoxin Associate I
Let’s Make Things Happen!
Ajinomoto Althea, Inc. is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical companies.
Althea is a leading expert in aseptic filling of drug product in vials and syringes, and our focused expertise and capabilities make us one of the industry’s top leaders for cGMP microbial fermentation of recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services including: upstream and downstream process development, complex formulations, lyophilization cycle, analytical development, product release and ICH-compliant stability testing.
Now is an exciting time to join Althea. We have talented people working together to help our clients advance their innovative product pipelines. We believe that people are our greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth.
Our work atmosphere is fast paced, stimulating and customer focused. Employees take pride in knowing our efforts are helping countless patients for years to come.
Althea is currently seeking a Bioburden & Endotoxin Associate I responsible for supporting manufacturing at Ajinomoto Althea, Inc. The Bioburden and Endotoxin Associate I may focus in a specialized area and provide routine analysis and testing according to standard operating procedures in any of the following areas: in process and final product testing and microbiology assays including TOC, conductivity, bioburden, endotoxin, and growth promotion.
- Performs microbiology assays and method qualifications to support routine water testing, in process and final product testing.
- Compiles data for documentation of test procedures. Analyzes data and results and presents conclusions to manager.
- Performs raw material release testing.
- Reviews and approves routine water data.
- Initiates routine investigation reports, out of specification (OOS) and deviations.
- Trains lower level personnel on quality control methods and SOPs.
- Reviews data obtained for compliance specifications and reports abnormalities to manager.
- Initiates revisions to current cGMP and SOP guidelines. Prepares routine SOPs for approval.
- Maintains lab area according to Althea’s 6S principles, including cleaning of benches, biosafety cabinets, shelving, and floors.
- Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
- 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.
- Embodies Althea’s cultural values and aligns daily actions with department goals and company culture.
- Bachelor’s degree strongly preferred in a Life Sciences discipline or equivalent.
- Minimum of two (2+) years of relevant experience in laboratory environment or equivalent.
- Experience with GMP, aseptic techniques, troubleshooting, and data entry.
- Ability to perform testing in a highly accurate and reproducible manner.
- Proficiency with Microsoft Office applications.
- 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.
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.
Successful Candidate must pass a background check and drug screen as a condition of employment.
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.