Senior Design Transfer Scientist

Natera•San Carlos, CA

23h

About The Position

The Senior Design Transfer Scientist will be responsible for facilitating the transition of products from Development to Operations. The Sr. Scientist will plan, execute, implement, and document all design transfer activities for an IVD/PMA assay under design control, for next generation sequencing (NGS) assays. The successful candidate will work within the R&D and collaborate cross-functionally with members of operations, bio-development, bioinformatics, quality, regulatory affairs, and clinical affairs. The Sr. Scientist is expected to divide time between working in the lab and at the desk and providing training and guidance to junior team members in their creation of design transfer documentation and execution of NGS experiments to support in vitro diagnostic (IVD) design transfer. The candidate will maintain a broad knowledge of state-of-the-art principles and theories. This role will also support regulatory IVD and PMA submissions from a design transfer perspective. The ideal candidate will be an enthusiastic, flexible team member who learns quickly, enjoys multi-tasking and most importantly, has an interest in our company and our products.

Requirements

Bachelor's degree plus 10 years of relevant experience OR a Master's degree with 7 years of experience OR PhD with 4 years of experience required
Strong scientific background in molecular and cell biology, Biotechnology, or Biochemistry
Extensive knowledge of design control
Experience working to policies; procedures and international quality standards or in a highly regulated industry
Knowledge of quality and regulatory standards and requirements (ISO, CLSI, FDA) is a must
Ability to follow and establish SOPs and in-depth knowledge of GLP/GMP guidelines
Experience authoring study plans, protocols and study reports is highly desired.
Adept with Excel and basic statistical analysis
Hands-on experience with statistical tools such as Minitab or JMP
Supervise junior scientists and team members in their experimental execution and technical documentation
Experience with nucleic acid technologies relating to NGS, PCR, qPCR and multiplex PCR
Hands-on experience with NGS and DNA/RNA molecular biology is preferred
Very strong analytical and problem-solving skills
Strong interpersonal and communication skills

Nice To Haves

IVD product development experience is a plus

Responsibilities

Conduct risk assessments (FMEA) to identify gaps in the process and come up with a strategy to make it compliant with IVD standards
Design and develop manufacturing, QC and commercial operations processes
Plan and execute laboratory research in relation to manufacturing scale up and improving process capability
Assure experimental quality through sound experimental design; utilizes DOE, Cpk analysis, Gage R&R and assists in the design of experiments for others
Plan and conduct stability studies with assistance from junior team members
Lead cross functional efforts in establishing supply chain for raw materials and consumables and propose improvements
Attend core team meetings, serve as a voice of operations and liaison between R&D and Operations
Lead test method developments and characterizations
Conduct studies to generate specifications
Set process and test method specifications based on statistical analysis
Lead test method validations and process validations
Set up product structures (BOMs), write SOPs, manufacturing and QC documents etc
Write various protocols and reports
Significant role in PMA submission, audit prep and qualification of suppliers and manufacturing processes
Present status update, data and proposals in various forums to technical and non-technical audiences
Lead junior members of the team