Illumina, Inc.
San Diego, CA, USA
We are looking for driven, talented scientists and engineers to join our growing Reagent Process Development (RPD) team. The RPD team works as an integral part of our Consumables Process Development and Transfer (CPDT) group and is tasked with establishing best practices for reagent process development, including characterization and design for manufacturability. This process scientist position is a hands-on, individual contributor where the incumbent uses knowledge of GMP manufacturing processes to support new product introduction initiatives of clinical/diagnostic products.
All About You
Responsibilities:
Leverage manufacturing experience and knowledge to support reagent process development, product characterization, and method development activities as needed
Collaborate with new product development teams throughout the stages of product development process (PDP) to:
Participate in the execution of controlled experiments (including DOE’s and gauge R&R studies) to develop processes for new products and improve processes of existing products
Execute analytical test methods to support process development activities, process scale up studies, change evaluations, and other Pilot Plant related activities.
Support establishment of process requirements and product specifications for successful transfer of technical information into manufacturing.
Formulate and fill development and pilot lots during the New Product Introduction process
Analyze results, troubleshoot, and contribute to root cause analysis
Make safety, compliance, and technical related recommendations as required
Elevate observations that will impact successful transfer of processes to production
Maintain and organize inventory of pilot plant equipment and supplies
Track, order, and receive reagents and disposables such as chemicals, enzymes, buffers, pipette tips, reagent tubes, etc. to ensure experimental work proceeds smoothly and efficiently
Clean and organize common areas in the pilot plant
Handle EH&S (e.g. lab safety training, hazardous waste disposal) and Facilities (e.g. equipment move) related tasks
Support equipment repair and calibration
Perform other duties as assigned, such as: maintaining reagents; purchase order placement and follow up accountability, participation in the execution of experiments; lab safety; lab organization.
Present clear and concise written and oral communications to colleagues and supervisors, participate in technical meetings, and provide recommendations based on technical results and experience
Requirements:
Experience with analytical methods (e.g. pH, refractometry, HPLC, LC-MS, SDS-PAGE), enzymatic assays, and other molecular biology techniques (e.g. PCR)
Demonstrated ability to troubleshoot laboratory or production processes
Knowledge of molecular biology and principles of next generation sequencing
Ability to work independently in a fast-paced team environment, meet deadlines, and adapt to rapidly changing priorities across multiple projects in accordance with departmental and company objectives.
Demonstration of excellent communication, interpersonal, and leadership skills
Must be able to clearly and legibly document steps completed in batch records or laboratory notebooks in accordance with Good Documentation Practices
Ability to work within an ISO 13485 and cGMP production environment and maintain compliance with our quality system.
Preferred Experience:
Work experience in production, pilot plant, or product development following GMP practices and/or 5S standards is strongly preferred
Experience and knowledge of operations for in-vitro diagnostics, other medical devices, or pharmaceutical products is strongly preferred
Experience with Design of Experiments techniques, statistical analysis, and statistical process controls
Understanding of the process of control requirements for production and process improvement as per QSR, FDA, ISO 90001/13485, and other regulatory requirements
Knowledge of document control, ERP/MRP control, and/or manufacturing execution systems
Education:
B.S./M.S. in Biochemistry, Chemistry, Biological Sciences, Bioengineering, Chemical Engineering, or equivalent disciplines with 0-2 yrs. of relevant work experience
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.
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. If you have a disability or special need that requires accommodation, please contact us at applications@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
recblid 98agjeta33zc738hg2fwcyc7qoic1i
We are looking for driven, talented scientists and engineers to join our growing Reagent Process Development (RPD) team. The RPD team works as an integral part of our Consumables Process Development and Transfer (CPDT) group and is tasked with establishing best practices for reagent process development, including characterization and design for manufacturability. This process scientist position is a hands-on, individual contributor where the incumbent uses knowledge of GMP manufacturing processes to support new product introduction initiatives of clinical/diagnostic products.
All About You
Responsibilities:
Leverage manufacturing experience and knowledge to support reagent process development, product characterization, and method development activities as needed
Collaborate with new product development teams throughout the stages of product development process (PDP) to:
Participate in the execution of controlled experiments (including DOE’s and gauge R&R studies) to develop processes for new products and improve processes of existing products
Execute analytical test methods to support process development activities, process scale up studies, change evaluations, and other Pilot Plant related activities.
Support establishment of process requirements and product specifications for successful transfer of technical information into manufacturing.
Formulate and fill development and pilot lots during the New Product Introduction process
Analyze results, troubleshoot, and contribute to root cause analysis
Make safety, compliance, and technical related recommendations as required
Elevate observations that will impact successful transfer of processes to production
Maintain and organize inventory of pilot plant equipment and supplies
Track, order, and receive reagents and disposables such as chemicals, enzymes, buffers, pipette tips, reagent tubes, etc. to ensure experimental work proceeds smoothly and efficiently
Clean and organize common areas in the pilot plant
Handle EH&S (e.g. lab safety training, hazardous waste disposal) and Facilities (e.g. equipment move) related tasks
Support equipment repair and calibration
Perform other duties as assigned, such as: maintaining reagents; purchase order placement and follow up accountability, participation in the execution of experiments; lab safety; lab organization.
Present clear and concise written and oral communications to colleagues and supervisors, participate in technical meetings, and provide recommendations based on technical results and experience
Requirements:
Experience with analytical methods (e.g. pH, refractometry, HPLC, LC-MS, SDS-PAGE), enzymatic assays, and other molecular biology techniques (e.g. PCR)
Demonstrated ability to troubleshoot laboratory or production processes
Knowledge of molecular biology and principles of next generation sequencing
Ability to work independently in a fast-paced team environment, meet deadlines, and adapt to rapidly changing priorities across multiple projects in accordance with departmental and company objectives.
Demonstration of excellent communication, interpersonal, and leadership skills
Must be able to clearly and legibly document steps completed in batch records or laboratory notebooks in accordance with Good Documentation Practices
Ability to work within an ISO 13485 and cGMP production environment and maintain compliance with our quality system.
Preferred Experience:
Work experience in production, pilot plant, or product development following GMP practices and/or 5S standards is strongly preferred
Experience and knowledge of operations for in-vitro diagnostics, other medical devices, or pharmaceutical products is strongly preferred
Experience with Design of Experiments techniques, statistical analysis, and statistical process controls
Understanding of the process of control requirements for production and process improvement as per QSR, FDA, ISO 90001/13485, and other regulatory requirements
Knowledge of document control, ERP/MRP control, and/or manufacturing execution systems
Education:
B.S./M.S. in Biochemistry, Chemistry, Biological Sciences, Bioengineering, Chemical Engineering, or equivalent disciplines with 0-2 yrs. of relevant work experience
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.
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. If you have a disability or special need that requires accommodation, please contact us at applications@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
recblid 98agjeta33zc738hg2fwcyc7qoic1i
