Process Development Scientist

Job Title – Process Development Scientist

Location - San Jose, CA

Duration – 6+ Months

Work hours: 8am-5pm, 40 hours/week

Client: Medical Device Company

Job Category: Research & Development

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

40 hours per week, Onsite

3 Must haves on the resume: PCR, QC, oligo quantification

JOB SUMMARY

The Process Development Scientist will play a key role as a core team member in the new product transfer activities. He/she will be responsible to lead the QC transfer tasks and bridge between R&D product development and QC operation. Work closely with product development team to perform Gage R&R studies to define QC specs and perform robustness study to provide handling information for QC protocols. Create a partnership with QC Operation, BPE and Quality to plan and integrate manufacturing validation activities. Perform experiments to support troubleshooting guide based on customer feedback/complaints.

DUTIES AND RESPONSIBILITIES

• Lead new product tech transfer activities to transfer QC assays from R&D to operation
• Perform Gage R&R studies to define QC assay specifications
• Generate manufacturing protocols for QC assays and Work Instructions for QC instruments
• Support verification and validation studies working with bio process engineering team
• Perform reagent stability studies as needed
• Coordinate effectively with different functional teams from Product Development, Bioinformatics, Operation, Quality, Product management, etc.
• Present scientific data to the cross-functional teams as needed
• Trouble shooting skills to address customer complaints
• Promotes a safe work environment. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices

MINIMUM QUALIFICATIONS

Education and Experience:
• Requires a minimum of a Bachelor’s degree in Chemistry/Biology sciences with 3 years of relevant experience or Master’s degree with minimum of 1 years of relevant experience.
• Minimum of 3 years of demonstrated experience in R&D or research laboratory environment in genomics technologies or related field.
• Experience in PCR, molecular biology techniques and oligo quantification techniques is required
• Knowledge of statistical methods and data analysis experience is required
• Experience in sequencing technologies is a plus
• Proven experience of working in cross-functional development teams and strong communication skills

Assets
• Master or Ph.D. in Chemistry/Biology science or engineering field preferred.
• Knowledge and experience with single cell genomics is strongly desired.