Assay Development Manager 8/17/2016

Tecan US Inc San Jose, CA

Company
Tecan US Inc
Job Classification
Full Time
Company Ref #
13287
AJE Ref #
575906986
Location
San Jose, CA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Doctoral Degree

JOB DESCRIPTION

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JOIN TECAN. JOIN THE MARKET LEADER

WORK IN AN INTERNATIONAL AND DYNAMIC ENVIRONMENT.





ASSAY DEVELOPMENT MANAGER

Reference Job #081-516



We are seeking the right individual to join our eFluidics group. Our ideal candidate is someone who is able to work efficiently as part of a team and who shares our passion for quality and innovation.



As part of a multi-disciplinary R&D team, this position will be responsible for all aspects of Assay Development and Reagent Formulation for an innovative microfluidics product in the Life Sciences industry. Work with partners to adapt their assays to the new platform, including optimization and performance assessment. Use experimental design and other tools as needed to develop assays that meet product specifications. Ensure appropriate documentation is in place for transfer internally or to OEM/collaborator/partner.



Duties will include, but are not limited to:



1. Responsible for assay development, reagent formulation and protocol development

for optimal product performance on platform. Understand competitive platform

performance and ensure assays meet product specifications.



2. Provide project management for application development on the platform including

managing, timeline, schedule, budget (if needed) and risks from concept through

transfer to Tecan internally or to OEM/collaborator/partner.



3. Meet with external parties to understand their current assay. Translate their current

assay protocols to design inputs/specifications for Tecan s platform adapt their

assays to the new platform, including optimization and performance assessment.

Use experimental design and other tools as needed to develop assays that meet

product specifications.



4. Work under GLP/GMP as needed and understand and apply ICH (Int l Conference on

Harmonization) and CLSI (Clinical Laboratory Standards Institute) standards as

required.



5. Manage biochemistry group. Hire and mentor employees, set and review targets,

design and run experiments, review data and presentations.



6. Responsible for smooth operation of nucleic acid and cellular laboratories and for

ensuring best practices are used in the group for assay development.



7. Work with the Operations and Quality Groups to ensure that the reagents meet

Tecan s Quality procedures. Institute design controls and GLP for the

project. Become familiar with the company s Product Development Process and

advise on modifications to ensure that it is suitable for new cartridge and reagent

products.



8. Support the Quality System and Quality Policy by following procedures / work

instructions and creating records to meet the requirements of Tecan s Quality

System.







TRAINING EXPERIENCE AND SKILL REQUIREMENTS:



* Ph.D. in Biochemistry, Genomics, Molecular Biology or related field.

* At least five experience developing commercialized nucleic acid reagent products (that

are part of an integrated system) in a regulated environment; familiar with 21 CFR 820

design control requirements.

* Experience developing immunoassays and working with cell assays and microarrays

desired.

* At least 3 years hands on bench experience in NGS and MDx.

* Ability to travel. International travel may be required 1-2 weeks per year.

* Excellent verbal and written communications skills required.

* At least 3 years supervisory experience in industry.









TECAN IS AN EQUAL OPPORTUNITY EMPLOYER. ALL QUALIFIED APPLICANTS WILL RECEIVE CONSIDERATION FOR EMPLOYMENT WITHOUT REGARD TO RACE, RELIGION, COLOR, NATIONAL ORIGIN, SEX, AGE, STATUS AS A PROTECTED VETERAN, OR STATUS AS A QUALIFIED INDIVIDUAL WITH DISABILITY.