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in San Diego, CA

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Hours Full-time, Part-time
Location San diego, California

About this job

Skills:
* Direct knowledge of manufacturing processes
* Direct knowledge of lyophilization, conjugation, formulation of IVD diagnostic products
* Thorough knowledge of cGMP requirements to ensure adherence to compliance policies and regulations.
* Through knowledge of ISO 13485 regulations and certification.
* Project management
* Through knowledge of non-conforming material, corrective and preventive action processes
* Knowledge on how to perform process investigations per FDA and ISO standards
* Knowledge of risk analysis per FDA and ISO standards
* Knowledgeable in molecular diagnostic systems or assays is a plus.

Duties:

* Regularly communicate with R&D, Engineering and manufacturing teams to understand the development of tests kits for in-house R&D, clinical trial, and customer use

* Develop and optimize formulations, and manufacturing processes

* Develop the operating protocols and documents that meets ISO 13485 and cGMP standards

* Support the implementation of automation processes to improve manufacturing throughput * Adhere to the OSHA safety code and company policies

* Work directly with QA personnel to support ISO 13485 and cGMP certification

Top qualities include:
1. Solid, practical knowledge of GMP and excellent at following Quality procedures
2. Formulation chemist with understanding of lateral flow AND PCR- Hands-on experience with PCR is REQUIRED
3. Hands-on manufacturing AND able to lead/manage a team of 4-5 Research/Manufacturing Associates
4. Min. 5 years' experience
5. Good understanding of start-ups and likes the chaos associated with such

Education:
* Bachelor's degree in Chemistry, plus a minimum of 5 years of experience in an in-vitro diagnostic industrial setting.




About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

Aerotek is acting as an Employment Agency in relation to this vacancy.