QC Biochemical Assay Scientist

at  Lumen Bioscience

SUMMARY:

Lumen Biosciences, based in Seattle, is a privately held, clinical-stage, fully integrated biopharmaceutical company. Founded in 2017, Lumen uses genetically engineered spirulina - a photosynthetic, edible algae – for manufacturing and delivering biologic drugs. The spirulina platform is applied to gastrointestinal, airway, and topical delivery of therapeutic proteins, including antibodies, bioactive peptides, enzymes, cytokines and vaccine antigens. Therapeutic areas of interest encompass infectious diseases, cardiometabolic diseases, inflammatory diseases, and enzyme deficiencies.
We are looking for a candidate with bioassay development experience to join our Quality Control team. This Quality Control (QC) Biochemical Assay Scientist will be involved in the design and execution of various types of bioassays, supporting assay method development, validation and assay transfer from R&D to the Quality Control team. This individual will devise, troubleshoot, and validate bioassays for in-process control and lot release. They will also be responsible for maintaining and reviewing cGXP records, assisting in managing quality events, data trending, and overall supervision of QC bioassay analysis activities.
This position will work closely with scientists on the Assay Development research team, as well as the Quality Control team.

EDUCATION AND EXPERIENCE:

• PhD in biochemistry, enzymology, or closely related scientific field plus 3 years of work experience in Quality Control/Developemnt in GMP compliance environment.
• OR-a bachelor’s or master’s degree in biochemistry or related scientific field plus 5 years of work experience in Quality Control
• Experience developing highly reproduceable custom immunoassays, PCR, ddPCR assays, enzyme assays, cell-based assay, and/or other types of assays
• Thorough understanding of the theory and practice of dPCR, cell based binding potency, ELISA, and enzyme activity assays
• Experience setting up, optimizing and deploying bioassay is highly desired.
• Experience in applying statistical techniques in data analysis and data trending.
• Demonstrated technical aptitude and experience with pharmaceutical tech transfer including analytical methods verification, and validation that are suitable for different phases of FDA clinical trial phase requirements.
• Well-organized and detail-oriented with strong technical skills, excellent written and verbal communication skills, and proven ability to multitask.
• Thorough knowledge of relevant cGxP, ISO 9001, and ICH requirements for document control and quality records
• Experience with electronic biological sample organization and tracking is preferred
• High integrity and ethics

Physical Requirements:

• Sit for extended periods of time (2 or more hours)
• Standing for extended periods of time (2 or more hours)
• Occasionally lift or carry up to 20 kg

This position requires working under the 21 CFR part 210 /211 standard pharmaceutical cGXP quality system processes.

The key duties and responsibilities for this position are as follows:

• In charge of new assay transfer from R&D to QC, to ensure robust assays can be executed in QC with a set of GMP compliance documentations. Analytical assay platforms such as PCR, dPCR, ELISA, MSD, and enzyme activity assays are the main focus.
• Conduct review of laboratory data and data trending.
• Troubleshoot assays and assist other lab members in ensuring high quality experimental execution and data recording
• Handle and track BSL-2 material
• Author and review quality documents such as SOP, OOS/OOT, CAPA and Change Control.
• Author test methods, development reports, study protocols and reports.
• Maintain and operate laboratory equipment safely and efficiently, including coordinating and conducting preventative maintenance, cleaning, calibration, and qualification activities
• Monitor, review, and trending of stability data.
• Coordinate sample analysis with on-site staff and third-party labs for stability, routine, qualification, verification, and validation activities
• Create, review, and edit analytical methods and procedures to contribute to continuous improvements in safety, quality, and efficiency.
• This job description is not designed to cover or contain a comprehensive listing of duties, activities, or responsibilities that are required of the employee. Other duties responsibilities, and activities may change or be assigned at any time with or without notice