Principal Scientist, PK/ADA

Altasciences•Everett, WA

1d•$87,000 - $115,000

About The Position

Your New Company! At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences. We are better together and together We Are Altasciences. About The Role Provides technical and scientific expertise as well as leadership in their area of scientific expertise. Responsible for training assigned personnel within their area of expertise as necessary. Ensure functional area is operating in full compliance to GLP requirements, protocols, and SOPs. Oversees and approves SOP creation and revisions for the functional area. Oversees method testing project plans and reports for assay validation and sample analysis methods. Communicates with Study Director, QAU and other departments proactively to ensure efficient resource management and quality data generation. Interacts with clients and works with the director to assist with the establishment of strategic direction

Requirements

Bachelor’s degree in Immunology/Biology/Chemistry or other scientific related discipline plus a minimum of 8 years of relevant laboratory experience.
5+ years of method development/method validation experience with PK and ADA assays.
5+ years as Senior Research Scientist or equivalent in a GLP environment (CRO), preferred.
Knowledge of regulatory agency guidelines, must understand general SOPs and have excellent knowledge of GLP regulations.

Responsibilities

Demonstrates adherence to Good Laboratory Practices (GLP).
May supervise other lab personnel as assigned.
Plans, schedules activities and resources related to preparation and execution of specimen analysis.
Oversees and reviews data to ensure accuracy, completeness, consistency and compliance.
Reviews and responds to client inquiries to assist in study and assay design.
Prepares and modifies SOPs as needed for the Laboratory Sciences department.
Prepares, reviews and participates in the validation/qualification of new and current methods for study analyses and laboratory equipment.
Supervises and assists with analytical quality control and lab proficiency programs as assigned.
Provide staff training in relevant methods and equipment use.
Review staff records to ensure compliance with GLP.
Could have scientists reporting to them.