202587 - Development Scientist
Industry
SCI
Region
CA-Bay Area
City
San Jose
State
CA
Rate
$DOE
Duration
12 Months
Description


Chipton-Ross is seeking a Development Scientist for a contract opportunity in San Jose, CA.

SUMMARY:
This position is responsible to lead the hardware testing and validation efforts, particularly focused on LC/MS applications using the triple quadrupole-based instruments to ensure comprehensive testing in compliance with FDA and international regulatory standards.

RESPONSIBILITIES:
Be an integral member on project core teams as a representative of the Verification and Validation department.
Operate within the Product Development Process and be familiar with the principles of working within a Quality Management System or regulated laboratories.
Lead the verification and validation efforts for IVD products that are compliant with FDA, IVDR and other international regulatory standards.
Write documentation, such as test plans, protocols, and reports.
Maintain documents that records all aspects of experimental design and results, following good documentation practices.
Independently perform experiments and generate data in support of product requirements.
Responsible for accuracy and completeness of auditable documents.
Support risk management activities as a technical subject matter expert (FMEA, Hazard Analysis, etc.)
Work successfully with other departments- including but not limited to Manufacturing, Quality, Regulatory, and Marketing - for the development, transfer, submission, and commercialization of IVD products.
Create and present formal Design Review presentations at key milestones.

REQUIRED EXPERIENCE:
5-10 years work experience (including advanced degree studies) with hands-on experience operating and maintaining LCMS with knowledge of method development, range of applications and software.
Strong knowledge of both LC and MS instrumentation.
Solid understanding in one or more of Proteomics, Lipidomics, Pharma/Biopharma, Clinical or Food & Environmental analytical industries.
Experience with IVD products and working under design control
Proven understanding of design control for regulated products (e.g. FDA, IVD, IVD-R, China and Japan regulations) and knowledge of applicable regulatory and quality standards used in product development process (e.g. ISO:13485 and 21 CFR 820)
Good understanding of controlled documentation and data systems.
Self-motivated and can work independently with minimal direction
Demonstrated ability for high-quality results, technical proficiency, laboratory skills, collaboration with other departments.
Ability to present and communicate (oral and written) information in a clear manner.
Computer skills such as Word and Excel.
Hands on experience working with LC Liquid Chromatography / MS- Mass Spectrometry

EDUCATION:
MS degree and 6+ years; PhD and 2+ years in Chemistry or relevant field (Biomedical engineering, Biochemistry, etc.).

WORK HOURS: Full-Time

Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.

Contact
Tyler Harrell
tharrell@chiptonross.com
CHIPTON-ROSS, INC.
420 Culver Boulevard
Playa Del Rey, CA 90293

Phone: (310) 414-7800 x307 or (800) 927-9318 x307

Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Employment will be contingent on candidate clearing pre-employment drug screen and background check.

Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.