Staff Scientist at Illumina, Inc. in San Diego, California

Job Description:

Responsibilities:

• Develop new products in fast-paced product development environment. Identify, evaluate, plan, and optimize research ideas leading to new robust assays and chemistries for Illumina’s product lines.


• Drive execution of sequencing reagent development activities on product development projects, including development of product design user needs, requirements, specifications, traceability, risk management (FMEAs, Hazard Analysis, etc), verification and validation


• Support product development strategy considering commercial and operational implications.


• Participate as an active member on product development teams to ensure completeness of the design history file.  Support creation, review, and management of technical documents


• Create and mature internal design processes


• Support change management as a key engineering technical expert for on-market systems


• Drive decisions and tradeoffs in regulated and non-regulated environments


• Maintain strong partnership with New Product Introduction, Operations, and QA/Regulatory teams to ensure seamless transfer of new products into manufacturing and the field


• Strong expertise in designing and developing analytical techniques and methods


• Explore new technologies and methodologies and identify creative solutions to overcome current limitations.


• Design, implement, analyze and present experiments to demonstrate feasibility of new methods and efficiently move products through pipeline.


• Write reports and present results and project assessments to Senior Management


• Optimize assay conditions to achieve commercial levels of stability, robustness and performance.


• Be a strong scientific individual contributor as well as a collaborative team member and proactive technical manager depending on project needs and be highly adaptive to changing project scopes and responsibilities.


• Lead projects and guide technical areas independently. Make decisions involving designing, performing, troubleshooting, analyzing and presenting experiments.


• Manage goals within defined target timeframes and make decisions regarding the goals and progress of project / functional teams.


• Perform other duties as assigned.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Requirements:

• Ph. D. in the Biological Sciences (biology, biochemistry, chemistry) with 5-7 years of experience in commercial product development.


• Proven track record in developing and launching medical/IVD products to the regulated market.


• Demonstrated experience in characterization and testing of complex reagent formulations.


• Highly motivated, meticulous individual with the proven ability to think innovatively toward solving problems effectively and efficiently.


• Strong background in biochemistry and enzymology with a sound understanding of genetic assay development.


• Proven record of transferring new products to manufacturing and/or QC in a fast-paced biotech environment.


• Able to work effectively to meet scheduled deadlines and prioritize multiple activities appropriately.


• Experience managing successful cross-functional teams and developing personnel.


• Excellent data analysis and interpretation skills. Knowledge of fundamental critical parameter management and testing using DOE approach.


• Excellent oral and written communication skills required to clearly explain complex issues, progress reports and technical roadmaps to a variety of audiences across functions and levels.


• Ability to translate corporate goals into executable plans understanding technical risks, mitigations and alternatives. 

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities

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