Quality Control (QC) Scientist-Molecular Biology & Virology

Location
Redwood City, CA, United States
Posted
Feb 04, 2021
Ref
1320787079
Hotbed
NextGen Bio
Required Education
Bachelors Degree
Position Type
Full time
Kriya Therapeutics is a transformative gene therapy company with the intent to expand gene therapy to broader disease indications leveraging in house manufacturing capabilities and novel therapeutic designs.

Our mission is to identify, develop, and bring to market high-impact therapies that have the potential to improve the lives of patients with prevalent and severe chronic diseases. We target conditions where the underlying biology is well-understood, rationally designing gene therapies for metabolic and other inflammatory diseases . Our lead programs are focused on the treatment of metabolic diseases such as diabetes (Type 1 and 2) and severe obesity.

Our team is made up of leading scientific experts who are passionate about improving patients' lives and easing the burden of these life-changing disorders for patients. Kriya employees are motivated by the promise of novel drug development and is driven to find more efficient and effective ways to conduct scientific and clinical evaluations that rapidly deliver impactful medicines to patients in need. Our leadership team has a track record bringing innovative new therapeutic treatments to a global market, and along with our seasoned board of directors, is fully committed to the responsible pursuit of transformative therapies that significantly impact patient health and wellbeing.

OVERALL SUMMARY

We are seeking a Quality Control (QC) Scientist with experience in analytical development, method validation, and quality control with an emphasis in molecular biology and virology. The position is heavily focused on benchwork and the applicant should have a desire to continue in a laboratory focused role. The Scientist will be a key member of the QC team that will support the internalization (transfer, qualification, and validation) and cGMP testing of AAV gene therapy products through quality control assays including ddPCR, qPCR, ELISAs, cIEF and other similar assays. The scientist will be responsible for working cross functionally with the Analytical Development and Process Development Functions.

PRIMARY RESPONSIBILITIES:

  • Independently draft and execute method qualification and validations.
  • Independently draft test method procedures.
  • Participate in QC testing of AAV gene therapy product according to cGMPs.
  • Prepare samples and maintain appropriate records for submission of samples to contract testing laboratories. Ship samples to contract labs.
  • Communicates with contract labs to obtain information regarding capabilities, test timelines, and costs for testing unable to be performed in-house. Prepares sample shipments and submission paperwork for contract laboratory testing.
  • Performs general lab support activities such as housekeeping, equipment maintenance, inventory/ordering of supplies.
  • Maintains compliance with all required training.

SKILLS REQUIREMENTS:

  • Bachelor's degree in a biological discipline (Molecular Biology, Biotechnology, Cell Biology, or equivalent) with 6 + years of experience or a or Masters degree with equivalent experience.
  • Demonstrated capabilities in molecular techniques: qPCR, protein analysis, DNA purification/analysis
  • Experience with aseptic technique, strong quantitative bench skills, experience in quality control assays for viral production, purification and quantification
  • Able and willing to learn new procedures and techniques
  • Applicants should be self-motivated, organized, capable of working independently and in a collaborative environment
  • Ability to prioritize and multi-task concurrent project demands, while maintaining exceptional attention to detail as well as organization
  • Experience with QC of viral vectors for gene therapy
  • Experience with ddPCR and qPCR
  • Experience with denaturing gels for DNA analysis
  • Able to communicate effectively to all levels of the organization
  • Detail-oriented and have good time-management skills
  • Proactive, co-operative, and willing to work in small team environment
  • Strong verbal, written, and interpersonal communication skills

WORKING CONDITIONS (ability to travel, lifting)

This is an exciting time to participate in the field of gene therapy in general, and to become a part of Kriya Therapeutics' fast-growing dedicated team. Kriya Therapeutics offers an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous science. Competitive compensation and benefits package can be expected.