Job Description

Job Title: Associate/Senior Associate, Assay Development and Quality Control Analytics

Job Location: Bothell

Date Written: Jan. 8, 2021

Written By: Samuel Li

GCRF Job Level: P2

GCRF Job Family: Professional

Bothell, Washington

Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation's Diagnostics platform. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated molecular diagnostic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer.

Job Summary:

The successful applicant will work as a member of the Protein Reagent Development and Production Department to develop and manufacture recombinant protein reagents including recombinant enzymes. He/She will mainly contribute to protein reagent assay development and quality control analytics.

Responsibilities:

* Support the development of analytical methods to access the purify, quantity and efficacy and stability of biologics for the process development and manufacturing.
* Author analytical method SOPs, test method validation plans and reports
* Execute development studies and test method validations
* Coordinate vendor IQOQ executions and authored final qualification reports for analytical equipment GMP readiness
* Updated and created all SOPs, reports, memos, and concept reviews as required
* Executed Quality Control release assays for development and GMP productions of enzyme products, completing all documentation and QC reports as required
* Perform analytical testing of enzymes on stability within specified time points and complete all documentation and authored stability reports
* Execute manufacturing of enzyme products following GMP documentation
* Procure all materials and related equipment for validations
* Effectively interact with upstream and downstream development functions of the bioprocess department and others of the Bothell operations to synergize the efforts of all the teams
* Support research and development activities when prioritized and required
* Produce customized enzyme reagents/formulations to meet the requests from global programs and teams
* Continue implementation of GMP lab readiness, labeling of all reagents and equipment and ensuring calibration status, organization, and safety requirements
* Actively collaborate with other functions such as Bioanalytical and QA
* Support upstream and downstream process development efforts when needed.
* Maintain development data record, and generate SOP, development and technical report and document for process transfer.
* Motivate to perform in the cooperative cross functional setting to optimize the protein engineering and production function.

Qualifications:

* BS in Biochemistry or related field with 1-3 year (Associate) and 4-7 years (Senior Associate) of relevant experience, with industry experience preferred.
* Extensive experience in assay development in several areas, including PCR and analysis of protein and enzymes, DNA, RNA, and cell lines.
* Strong analytical and problem-solving skills are necessary.
* Demonstrated ability to collaborate effectively on cross functional teams to achieve objectives.
* Excellent communication, inter-personal and organizational skills are required.

Other requirement:

Occasional weekend work schedule is expected.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.