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Basic Function and Scope of the Position:
Lead technology & process transfer of QC methods into Reagent Manufacturing. This includes development, qualification and support of QC methods used to assess quality of liquid reagents and sub-assemblies.
Tasks and Responsibilities:
- Project lead for establishing new processes/products in QC Reagent Test department
- Collaborate with development to identify, select, develop, qualify, implement, and validate test methods and/or measurement systems for use in consumables manufacturing
- Support development and transfer new processes/products to production and enhance their robustness
- Define QC process requirements including instrumentation, consumables, software, personnel, work instructions and training
- Ensure process deliverables are completed within timelines for new product introduction (NPI)
- Recognize potential issues, understand and troubleshoot assays
- Provide technical support for new and established QC methods (i.e. QC specifications, forced failure studies, troubleshooting, etc.)
- Analyze test results, issue reports and make technical recommendations
- Carry out complex data analysis and troubleshooting
· Provide technical leadership to ensure optimal performance of production test methods and equipment
· Attend and represent department in technical team meetings related to NPI transfers
- Keep detailed records and prepare presentations for mid and upper management, as directed
- Excel proficiency required for data management
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Preferred Educational Background:
· BS/MS in a related scientific field (i.e. biology/molecular biology/biochemistry/chemistry) with 5+ years of relevant industry experience in pharmaceutical or biotech field.
Preferred Experiential Background:
· Experience in molecular biology/nucleic acid-based techniques such as DNA amplification, labeling, purification, quantification, PCR, RT-PCR, array-hybridization, etc.
· Proficiency with next generation (NGS) sample preparation and sequencing techniques
· Hands-on, intermediate level experience with the following instruments & techniques; HPLC, LCMS, ICS, UV/fluorescence spectroscopy, biochemical (enzyme) assays desired
· Experience in troubleshooting library prep, sequencing and/or analytical assays
· Ability to lead complex projects with little oversight
· Quality oriented, highly organized, and timeline driven
· Able to work in a fast paced environment; easily adaptable to changing priorities
· High-level experience with complex statistical analyses, JMP distribution analysis
· Strong technical writing experience in SOP’s, protocols, and reports
· High level problem solving and reasoning skills required
· Demonstrated ability to prioritize and accomplish goals while working across departments is essential
· Ability to communicate effectively and build strong relationships across multiple departments
· Honest and strong work ethic a must
· Approachable, personable, non-abrasive personality highly desired
Illumina believes that everyone has the ability to make an impact, and 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.