This is a unique position that requires significant understanding and application of both existing and new scientific methods and knowledge in accordance with GMP standards. Responsible for operating standardized scientific procedures and techniques in a highly regulated environment (GMP compliant) for clinical research applications; contributes to the planning, design, execution, and interpretation of process optimization experiments (process development and/or assay development); makes detailed observations, records data, as well as assesses the processes and results for reliability/efficacy/compliance. Assists in preparation of reports, regulatory submissions, and the drafting of standard operating procedures for novel techniques.
- Train and lead Laboratory personnel
- Write and establish specifications, test methods, and Standard Operating Procedures
- Perform QC assays, environmental monitoring, and sterility testing
- Review QC laboratory data
- Conduct laboratory investigations
- Perform laboratory internal audits and validation activities
- Manage contract laboratories and testing
- Comply with Institute policies and procedures
- Maintain a safe and healthy work environment
Additionally, the successful candidate will develop, implement, and manage the following programs:
- Laboratory sample management – sample receipt, tracking, testing, disposition, product stability, and retention systems.
- Product specifications, generation of Certificate of Analyses, management of contract laboratories, testing, and service agreements.
- Microbiology testing, including environmental and sterility testing.
- Analytical test method development.
- Laboratory equipment qualification, calibration and preventive maintenance.
Seattle Children's Employer Highlights:
- Leader in Pediatric Care: Because of our people, Seattle Children’s is recognized as a leading teaching, research and specialty care center at the forefront of pediatric care.
- Competitive Benefits: We support a healthy work–life balance. Our benefits include employee care, paid time off, health insurance and retirement savings.
- Transportation Discounts: Company bike program, on-site zip cars, unlimited ORCA transit pass, daily commute bonus provided to staff who us alternate methods of travel to/from work, company vanpools.
- Diversity/Inclusion: We strive to maintain an atmosphere that reflects our values of inclusion by providing effective and respectful care compatible with each patient and family's beliefs, values, and heritage.
- Bachelor’s Degree in an engineering or scientific discipline.
- Minimum to two (2) year’s experience in a related area/laboratory setting.
- Strong experience in applying Good Manufacturing Practice to Quality Control laboratories to conform to US and EU standards.
- Master’s Degree in applicable field/research specialty highly preferred.
- Significant experience conducting research in area of specialization.
- Some experience with laboratory management.