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Develop and implement QC methods for enzyme activity assays in manufacturing for liquid reagents used in Illumina’s Sequencing and BeadArray platforms.
Lead development of functional and/or analytical QC methods for use in Reagent Manufacturing and experience in enzyme activity assay
Evaluate existing functional QC methodologies, propose and implement alternative approaches that improve cycle time and/or robustness
Work closely with Development teams to ensure QC processes for new products meet Manufacturing requirements
Lead QC method implementation in manufacturing:
Validate functional/analytical QC methods that are related to enzymes
Select and qualify instrumentation and related software
Define and establish process requirements (instruments; personnel; training, documentation, software; etc.)
Provide technical leadership to support product and process development (including design, development, analysis, troubleshooting, etc).
Plan and execute laboratory research
Engage in collaborative research, work routinely with cross-function teams
May oversee several QC/Research Associates
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.
Demonstrated capability to develop QC methods for liquid reagents used in complex biological assays
Expertise with at least several of the following techniques: HPLC, SEC, CE, GC, GC-MS, LC-MS, MALDI-TOF, SDS-PAGE, IEF
Strong background in method qualification and transfer of QC processes into manufacturing
Strong background in analytical characterization of enzymes, oligonucleotides
Experience in a Regulated and/or GMP environment is a plus
Ability to effectively multi-task and prioritize activities
Excellent verbal/written communication skills
Expertise with next-generation sequencing platforms a plus
Experience with databases a plus
Ph.D. in Molecular Biology or Biochemistry with 7-10 years’ experience, minimum 5 years industry
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.