Technical Transfer Associate, Drug Product Manufacturing
Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. In July of 2018, Argonaut acquired LyoGen, a leader in dose specific lyophilization capabilities for the diagnostics markets. Argonaut provides quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.
Position and Scope
The purpose of this position is to transfer product and process knowledge from developmental clinical production to GMP product manufacturing in the drug product manufacturing division of Argonaut.
- Facilitate transfer of new processes from client lab or concept to drug product manufacturing by collaborating with subject matter experts and operations management
- Participate in client discussions via phone, video conference, and/or onsite visits
- Create and revise client-specific batch records, raw material specifications, and any documentation related to Drug Product Manufacturing
- Review executed batch records and other documentation, as needed
- Track and trend documentation issues
- Adhere to cGMP guidelines
- Bachelor’s degree in a life science or engineering discipline with 1-3 years’ relevant experience or a high school diploma/equivalent and 3-5 years’ relevant experience
- Familiarity with 21 CFR Part 11 GMP guidelines
- Time and project management skills with the ability to multitask are essential
- Must be able to effectively communicate within department and cross-functionally with other divisions
- High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction
- Proficiency in Microsoft Office; including Word, Excel, and Overlook
Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies with all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.