Senior Process Development Engineer
Personal Genome Diagnostics (PGDx) is seeking a motivated, enthusiastic individual to develop and improve technical manufacturing processes for medical, research, and investigational devices. The successful candidate will have a background in Molecular Biology or similar field and have expertise in sustaining engineering, analytical chemistry and molecular biology techniques
- Supports all aspects of manufacturing technology, including new product/process introduction, continuous improvement, and sustaining engineering.
- Leads day-to-day operation of technical manufacturing, including HPLC purification and analytical tools used for NGS (qPCR, Bioanalyzer/TapeStation, capillary electrophoresis)
- Subject matter expert on technical manufacturing processes; leads decision-making and implementation for improvements, including:
- Identifying process capability or quality issues, opportunities for COGS and cycle time reduction, and strategies for improving product sustainability
- Leading the design, validation, and implementation of new manufacturing processes or modifying existing manufacturing processes
- Resolves issues and delays in production as technical manufacturing subject matter expert.
- Represents Operations on new product project teams as needed.
- Assures product and process quality by ensuring manufacturing procedures follow quality and regulatory requirements.
- Trains operations personnel on new processes and ensures critical expertise and equipment for new processes are present in Operations.
- Conducts daily work independently.
- Develops and supports preventive safety culture and upholds the highest level of quality & safety in all aspects of the job.
REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s Degree in Molecular Biology or related scientific discipline with 7+ years of experience in a medical device manufacturing environment
- Demonstrated knowledge of ISO and/or cGMP
- HPLC expertise required.
- Analytical tools used for NGS (qPCR, Bioanalyzer/TapeStation, capillary electrophoresis) expertise required.
- Experience with automated manufacturing systems preferred.
- Experience in 510k and/or PMA IVD manufacturing environment preferred.
- NGS experience preferred but not required
- Ability to work in dynamic, fast-pace environment, and effectively manage change
- Driven and self-motivated
- Strong interpersonal and communication skills
- Strong organizational skills and attention to detail
- Strong project management skills
- Excellent communication and documentation skills required
ABOUT PERSONAL GENOME DIAGNOSTICS
Personal Genome Diagnostics (PGDx) empowers the fight against cancer by unlocking actionable information
from the genome. We are committed to developing a portfolio of regulated tissue-based and liquid biopsy
genomic products for laboratories worldwide. PGDx was established by internationally-recognized cancer
researchers Dr. Luis Diaz and Dr. Victor Velculescu, who are pioneers in the application of innovative genomic
technologies for drug development and clinical practice.
Please submit applications (cover letter and resume) to HR@personalgenome.com
Special consideration will be given to internal PGDx employees who apply.
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