LOCATION:

This will be a hybrid-role and candidates will be considered for either our Austin, TX or San Carlos, CA locations. 

POSITION SUMMARY:

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, aligning with stakeholders on project strategies 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 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.

PRIMARY 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 executes 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.
• 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.
• Author SOPs, manufacturing and QC documents etc.
• Write various protocols and reports.
• Participate in regulatory 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.
• May lead more junior members of the team.

QUALIFICATIONS:

• 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.

KNOWLEDGE, SKILLS, AND ABILITIES:

• 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.
• Knowledge of design control.
• 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 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.
• Hands-on experience with molecular biology techniques is a must.
• Hands-on experience with NGS and DNA/RNA molecular biology is highly preferred.
• IVD product development experience is a plus.
• Experience with scale up and automation projects is a plus. 
• Very strong analytical and problem-solving skills.
• Strong interpersonal and communication skills.