Research Associate 2 at Illumina, Inc. in San Diego, California

Job Description:

As an Research Associate 2 in Illumina’s 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 method qualification, validation and inter/intra-laboratory analytical method transfers of analytical assays used for quality release inspections as well as full functional nucleotide and primer in-process release testing to assemble consumable products kits. 

Responsibilities:

• Validation and transfer of analytical methods for consumable products. Some late stage analytical development and qualification may be required.




• Develop and execute method validation protocols for analytical 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 standards.




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




• Perform and/or support investigation of out of specification results.




• 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 review results 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 Illumina’s Method Validation procedures.




• Participate in fast paced multidisciplinary development and troubleshooting teams.




• Deliver results in a fast-paced, results orientated within the process development environment.




• Perform other duties as assigned including instrument and equipment onboarding.

Requirements:

• At least 2-5 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.




• 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/ASQ; 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 preferred.

Education:

• B.S./M.S. in Biochemistry, Molecular Biology, Chemistry or similar scientific fields

Concerns regarding COVID-19 continue as positive cases are experienced in the communities in which we operate. Please be aware that, as a condition of employment, Illumina may require proof of COVID vaccination in accordance with local statutory requirements (subject to limited exceptions) beginning November 1, 2021.

At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf