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Product Transfer Associate (sunnyvale)

By | July 6, 2009

About Us

Cepheid (Nasdaq: CPHD), based in Sunnyvale, Calif., is an on-demand molecular diagnostics company that develops, manufactures, and markets fully-integrated systems and tests for genetic analysis in the clinical, industrial and biothreat markets. The Company’s systems enable rapid, sophisticated genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. Cepheid’s easy-to-use systems integrate a number of complicated and time-intensive steps, including sample preparation, DNA amplification and detection, which enable the analysis of complex biological samples in its proprietary test cartridges. Through its strong molecular biology capabilities, the Company is focusing on those applications where rapid molecular testing is particularly important, such as identifying infectious disease and cancer in the clinical market; food, agricultural, and environmental testing in the industrial market; and identifying bio-terrorism agents in the biothreat market.

http://www.cepheid.com

Cepheid@agents.icims.com

Position Description:

A Product Transfer Associate will be responsible for supporting Product Transfer projects under the guidance of Senior Associate/Scientist/Manager. A key part of this position is developing and transferring to manufacturing, processes such as bulk processes (liquid), lyophilization processes and in general involve bulk quantity reagents for manufacturing Cepheid products.

Perform routine testing of PCR based assays and other biological/chemical assays to support the Product Transfer group function within Manufacturing.

Scope of testing will include preparation of reagents/chemicals, performing testing using instrumentation and application SW, follow both established procedures and conducting non-standard testing under the guidance of Product Transfer Scientist/Engineer.

Review/Analyze data using established procedures and summarize in a report format.

Support process improvement, cost reductions and troubleshooting efforts within the Manufacturing organization. Support the development of manufacturing worksheets and procedures.

Support process development for new Cepheid products and transfer to Manufacturing

Requirements:

SKILL: Applies acquired job skills and company policies and procedures to complete assigned tasks.

JOB COMPLEXITY: Works on assignments that are semiroutine in nature but recognizes the need for occasional deviation from accepted practice.

SUPERVISION: Normally follows established procedures on routine work; requires instructions only on new assignments.

EXPERIENCE: Typically requires a minimum of 1 – 2 years of related experience.

Basic knowledge of GLP practices involving biological reagent handling and formulation. Basic knowledge of molecular biology techniques, especially work with nucleic acids and biochemicals.

Basic knowledge of GMP practices for processes that will be transferred to manufacturing.

Previous experience in process development and transfer to manufacturing desirable.

Experience with IQ/OQ/PQ for process equipment.

Knowledge of laboratory equipment (e.g. pipettors, spectrophotometers).

Knowledge of MS suite of tools such as Excel, Word.

Excellent verbal and written communication skills are essential. Attention to detail and good record-keeping skills are essential. Capable of working independently under minimal supervision.

Preferred Qualifications

Bachelor’s degree in a scientific/engineering discipline, preferably with a minimum of 2 years of industrial experience.

Cepheid administers its personnel policies and conducts its employment practices in a manner that treats each employee and applicant for employment on the basis of merit and experience, without regard to race, creed, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), age, physical or mental disability, marital status, sexual orientation, citizenship status, ancestry, religion, gender identity, or any other protected characteristic as established by law.

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