Position Summary:

As an Analytical Chemistry Scientist II at Illumina’s Reagent Development Services – Analytical Method Development and Transfer Group, you will work in a dynamic, team-oriented environment, collaborating with internal and external partners to develop, validate and, transfer analytical methods to support formulation development, stability testing, and quality control testing of raw materials, intermediates, and final products in accordance with project timelines. This position requires strong knowledge of chromatographic, spectroscopic and enzymology assay techniques as well as hands-on experience in development of high quality and robustness analytical methods.

Responsibilities include:

• Plan and execute various laboratory experiments under general direction.
• Develop, validate and transfer test methods according to Good Manufacturing Practice (GMP) and/or regulatory requirements (FDA 21 CFR Part 11 and ISO).
• Prioritize assignments. Deliver results within project timelines.
• Perform data analysis and troubleshoot aberrant results and draw sound conclusions.
• Prepare study protocols and reports. Write assay work instructions.
• Observe and comply with GMP and Good Documentation Practice (GDP).
• Work with all members of staff to maintain and develop the positive progressive culture.
• Undertake other duties as assigned by manager.
• Requirements: BS with Minimum 2 years of experience in analytical method development, qualification, validation and transfer using various analytical techniques such as HPLC, LC-MS, CE, UV, NMR, Fluorescence plate readers, enzyme activity assays, etc.
• Ability to perform collaborative experiments with team members across multiple disciplines.
• Highly proficient, productive, and effective in the lab. Excellent lab organization and documentation skills.
• Knowledge and working application of method validation principles for regulated industries including FDA cGMP; ICH/USP guidelines, ANSI/ISO/ASQC.
• Excellent verbal/written communication and interpersonal skills. Flexible and adaptable.
• Must be analytical, detail-oriented, organized, takes initiative, and self-motivated.
• Hands on experience with Next Gen Sequencing (NGS) technologies a plus.
• All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
• Education: B.S./M.S./Ph.D in Analytical Chemistry, Chemistry, Biochemistry, Molecular Biology, or similar scientific fields.