Process Development Scientist

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
• Cookordinate effectively with different functional teams from Product Development, Bioinformatics, Operation, Quality, Product management, etc.
• Present scientific data to the cross-functional teams as needed
• Troubleshooting 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

• 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.