This person will play an integral role in providing technical collaboration for the Process Development & Transfer Team focused on method qualification, validation and inter/intra-laboratory analytical method transfers of enzyme activity assays used for quality release inspections as well as full functional nucleotide and primer in-process release testing to assemble consumable products kits.
location: San Diego, California
job type: Contract
salary: $40 - 45 per hour
work hours: 9 to 5
- 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.
- At least 5-7 years of experience in analytical method development, qualification, validation and transfer
- Minimum 3 years of technical writing in many of the following areas: validation protocols, validation reports, SOPs, engineering/ development reports.
- 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.
- Hands on experience with Next Gen Sequencing (NGS) technologies a plus
- B.S./M.S. in Biochemistry, Molecular Biology, Chemistry or similar field
skills: GLP (Good Laboratory Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.