Senior Engineer- Process Development

Illumina•San Diego, CA

43d

About The Position

What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. We are looking for a driven, talented individual to join our Manufacturing Technical Operations (MTO) group. The MTO group works as an integral part of our Consumables Manufacturing process and is tasked with increasing quality and yield within our production environments. This individual will provide technical leadership to new product introduction, production process development, improvement and sustaining efforts. Additionally, these teams will partner cross-functionally with R & D, Quality, Production and other engineering groups to develop processes for new products and sustain and improve processes for existing products.

Requirements

Demonstrated ability to make oligonucleotides, nucleotides, and/or associated subassemblies
Manufacturing experience of organic synthesis is required
Knowledge and experience of scale-up chemistry, preparative and analytical chromatography, LC-MS and ability to interpret NMR is required
Working knowledge and experience of automated synthesis, manufacturing execution system (MES) and SQL is desirable
Experience in process support and development in a GMP environment
Strong analytical, problem-solving, troubleshooting, and root cause analysis skills
Strong interpersonal, verbal and written communication skills required
Must be detail oriented
Strong understanding of GMP is desirable
Experience with standard laboratory practices
High level computer skills are required. Programming knowledge is a plus.
Experience with SAP or equivalent ERP system is desirable
Experience working in an ISO 13485 or FDA regulated environment is desirable
Experience with lean manufacturing tools and principles is a plus
Experience with statistics, Statistical Process Control and DOE techniques is desirable
Typically BS/MS degree with 5+ years of related experience ; or a PhD with 3 years' experience; or equivalent experience.
Field of study in Chemistry, Organic Chemistry, Analytical Chemistry, or Chemical Engineering with emphasis on Synthetic Organic Chemistry preferred

Responsibilities

Provide technical leadership in the production and analysis of oligonucleotides, modified/functionalized Nucleotides, in a regulated manufacturing environment.
Collaborate with cross-functional teams to both (1) address operational sustaining needs (i.e. resolve production issues related to safety, yield, quality, and/or throughput) and (2) develop and transfer new processes/products to production and/or to enhance existing processes/products
Represent and advocate for Operations' needs in cross-functional meetings to ensure quality, continuity and efficiency of products and processes transferred to and implemented within manufacturing teams.
Utilize change management practices to drive safety, quality, efficiency, and/or cost improvements.
Identify, analyze trends, monitor and update Manufacturing KPIs and metrics.
Lead or support non-conformances/CAPA's through technical evaluations and investigations.
Identify, drive and support continuous improvement and sustaining activities.
Select appropriate components and vendors in area of responsibility, without oversight.
Lead and support teams in the transfer of manufacturing processes between manufacturing locations.
Responsible for productive cross-site and cross-functional relationship between manufacturing sites.
Execution of manufacturing builds when needed to support Development, Pre-Production and Production orders.
Plan and prioritize assigned tasks and activities with minimal guidance.
Execute tasks independently and with guidance as necessary from project lead or manager.
Influence technical decisions in own area of responsibility.
Track component COGS and associated project expenses

Benefits

all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package
We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.

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