Process Development Scientist

Agilent Technologies

About The Position

Agilent is known for high product quality and technological innovation. Our people possess an innovative and digital drive. They incorporate automation, advanced materials, or AI into their work with sustainability in mind. Use your skills to maintain and improve our integrity and the quality of our products, and become part of a collaborative company that encourages freedom, influence, and development. Currently we are hiring for a Process Development Scientist in Cedar Creek, Texas. Responsibilities for the role will include: Support the development, transfer, scale-up, validation, and continuous improvement of manufacturing processes and equipment for Agilent’s Genomics line of products.. Supports process and test method development and scale-up of manufacturing processes for production in a lab environment. Writes and implements shipping and stability studies. Designs and optimizes processes for manufacturing using statistics-based experimentation and principles of process excellence including DfM practices. Works with internal organizations and vendors to ensure regulatory and company compliance of manufacturing processes. Involved in new product scale-up, purification, process optimization, technology transfer and process validation activities. Develops production procedures and product specifications. Supervises the performance of processes and equipment and makes recommendations for quality and continuous improvements. Works with equipment vendors to define, develop, implement and qualify process equipment.

Requirements

Bachelor's or master's degree in a related discipline.
3+ years of experience with a minimum of 2 -3 year of experience as a support scientist in a manufacturing environment.
Strong technical understanding and excellent bench skills in one or more of the following areas: NGS, Microarray, PCR/QPCR, Laboratory Automation

Nice To Haves

Experience working in a regulated environment, and familiar with regulatory standards and requirements (ISO13485, 21 CFR Part 820, or similar).
Experience designing/writing/executing validation plans, equipment qualifications, stability studies, protocols, and/or shipping validations.
Experience implementing DfM and/or QbD approaches during NPI transfers.
Use of statistical techniques and statistical and graphical tools to analyze experimental data, troubleshoot and optimize processes, perform sample size calculations.

Responsibilities

Support the development, transfer, scale-up, validation, and continuous improvement of manufacturing processes and equipment for Agilent’s Genomics line of products.
Supports process and test method development and scale-up of manufacturing processes for production in a lab environment.
Writes and implements shipping and stability studies.
Designs and optimizes processes for manufacturing using statistics-based experimentation and principles of process excellence including DfM practices.
Works with internal organizations and vendors to ensure regulatory and company compliance of manufacturing processes.
Involved in new product scale-up, purification, process optimization, technology transfer and process validation activities.
Develops production procedures and product specifications.
Supervises the performance of processes and equipment and makes recommendations for quality and continuous improvements.
Works with equipment vendors to define, develop, implement and qualify process equipment.