Associate Scientist - San Diego , CA | Biospace
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Associate Scientist

Apex Life Sciences

San Diego , CA
Posted Date:
Position Type:
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Assay, Bioanalytical, Biochemistry, HPLC, PCR,

Job Description

Our Client, a developer, manufacturer, and marketer of integrated systems for the analysis of genetic variation and biological function is seeking a qualified Associate Scientist to join their expanding team.


This position provides technical collaboration for product development programs or projects involving department or cross-functional teams focused on validation of inspection methods used during assembly of consumable products.


Perform late stage analytical development, qualification, validation and transfer of inspections methods for consumable products.

Develop and execute validation protocols for inspection methods used at all levels of consumable manufacturing.

Analyze test results, draft validation/engineering reports and make technical recommendations.

Participate in project management meetings as analytical methods validation representative determining validation requirements, as needed.

Learn and understand the applicable technology and engage in technical discussions.

Provide expert technical input with respect to method validation requirements and related Regulatory requirements.

Ensure test method validation program meets requirements of FDA (21 CFR Part 11) and ISO.



B.S./M.S. in Biochemistry, Molecular Biology, Chemistry or similar field

At least 3-5 years of experience in analytical method development, qualification, validation and transfer.

Minimum 2-3 years of technical writing in many of the following areas: validation protocols, validation reports, SOPs, engineering/ development reports, validation master plans.

Must be an effective communicator, able to effectively lead teams and interface well with the organization.

Strong user level experience with many of following techniques: biochemical (enzyme) assays, binding capacity assays, UV/fluorescence spectroscopy, HPLC and qPCR.

Expert knowledge and working application of method validation principles for regulated industries including: FDA cGMP; ICH/USP guidelines ANSI/ISO/ASQC; FMEA, Risk Analysis and Design Controls.

Experience with statistics, Statistical Process Control and DOE techniques is desired.