POSITION SUMMARY:
 

The Design Transfer Scientist will be responsible for supporting the transfer of products from Development to Operations. The Scientist will assist in planning, execution, implementation, and documentation of all design transfer activities for an IVD/PMA assay under design control, for next generation sequencing (NGS) assays. The Scientist is expected to divide time between working in the lab and at the desk. 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:

• Assist in test method development and characterization.
• Participate in specification generation.
• Plan and execute  stability studies.
• Assist in test method validations and process validations.
• Collaborate cross functionally to establish supply chain for raw materials and consumables and propose improvements.
• Participate in collaborative efforts with R&D and subject matter experts for successful transfer of new product designs, including product requirements and material specification development
• Serve as lead on automation projects from a design transfer perspective.
• Perform and document change control activities.
• Write standard operating procedures (SOPs), study protocols, reports and other documentation 
• Day-to-day hands on work in the laboratory including generating, recording, and analyzing experimental data
• Present status update, data and proposals in various forums to technical and non-technical audiences.
• Other duties as assigned

QUALIFICATIONS:

• Bachelor’s degree with atleast 8 years of experience OR Master’s degree with 6 years of experience OR PhD with 3 years of experience.
• 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).
• 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. 
• Knowledge of design control.
• Adept with Excel and basic statistical analysis.
• Hands-on experience with statistical tools such as Minitab or JMP.
• Experience with scale up and automation projects is a plus.
• Experience with molecular biology techniques such as PCR, qPCR and multiplex PCR is a must.
• Hands-on experience with NGS and DNA/RNA molecular biology is highly preferred.
• Prior Manufacturing and QC experience is a plus
• IVD product development experience is a plus.
• Very strong analytical and problem-solving skills.
• Strong interpersonal and communication skills.
• Effective time management and organizational skills; able to balance multiple priorities
• Excellent communication and analytical skills
• Proven ability to execute and deliver on commitments