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Our client is seeking: Associate Scientist, As an Associate Scientist I in the Reagent Development Services – Analytical Method Development Transfer Group, you will play an integral role in providing technical collaboration for the Process Development & Transfer Team focused on test method qualification, validation and inter/intra-laboratory analytical method transfers of enzyme activity assays used for QC release inspections as well as nucleotide and nucleic acid in-process release testing to assemble consumable products kits.
- Validation and transfer of inspection methods for consumable products. Some late stage analytical development and qualification may be required.
- 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
- Ensure test method validation program meets requirements of FDA (21 CFR Part 11) and ISO
- Learn and understand the applicable technology and engage in technical discussions.
Compensation, Benefits, and Employment Type
- Full Time: 6 month+ Contract
- Pay Range: 35-38/hr.
- San Diego, CA 92101
- Job# bh11343
Must be able to recognize potential problems, understand and troubleshoot assays and associated instruments. Conduct focused experiments under general direction of area lead by planning, conducting, analyzing, interpreting, and reporting recommendations based on tested experimental results. Independently execute qualification and validation testing of new analytical methods and verify method calculations. Complete associated paperwork in accordance with appropriate good documentation standards. Keep secure laboratory data using electronic notebooks, write protocols and reports, and prepare presentations. Become an expert in our Method Validation procedures. Perform other duties as assigned including instrument and equipment onboarding.
- User level experience with some of the following: enzyme activity, bead binding capacity, nucleotide and nucleic acid analysis using controls and standards characterized on UV/fluorescence spectroscopy and/or HPLC systems.
- Knowledge and working application of method validation principles for regulated industries including FDA cGMP; ICH/USP guidelines ANSI/ISO/ASQC; FMEA, Risk
Excellent verbal/written communication and interpersonal skills. Flexible and adaptable. Analytical, detail-oriented, organized, takes initiative, and self-motivated. Utilizes process driven approach to experimental design and troubleshooting, including understanding of DOE and statistical analysis. Excellent lab organization and documentation skills.
MSc or BSc in Biochemistry, Molecular biology, Bioengineering or other applied Biology or Chemistry field with a minimum 3-5 years working experience in a regulated environment
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