Research Associate 1/2, Analytical Development/Quality Control

Location
Emeryville, CA
Posted
Jul 10, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
4D Molecular Therapeutics, Inc. (“4DMT”) is a clinical-stage gene therapy company pioneering the development of product candidates using targeted and evolved AAV vectors. 4DMT seeks to unlock the full potential of gene therapy using its platform, Therapeutic Vector Evolution, which combines the power of directed evolution with approximately one billion synthetic capsid sequences to invent evolved vectors for use in targeted gene therapy products. The company is initially focused in three therapeutic areas: ophthalmology, cardiology, and pulmonology. The 4DMT targeted and evolved vectors are invented with the goal of being delivered through clinically routine, well-tolerated and minimally invasive routes of administration, transducing diseased cells in target tissues efficiently, having reduced immunogenicity and, where relevant, having resistance to pre-existing antibodies. 4DMT is currently conducting three clinical trials: 4D-125 is in a Phase 1/2 clinical trial for XLRP, 4D-110 is in a Phase 1 clinical trial for choroideremia and 4D-310 is in a Phase 1/2 clinical trial for Fabry disease.

4DMT is focused on attracting and retaining the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers competitive salary and benefits, and provides challenging opportunities for career development.  4D Molecular Therapeutics is located in Emeryville, CA.

GENERAL SUMMARY:
The Research Associate in Analytical Development/Quality Control (ADQC) is responsible for performing routine analytical testing, data analysis, and method development/qualification. The candidate will work closely with Process Development, Research, and Quality organizations. The successful candidate will be experienced with analytical techniques including but not limited to qPCR/ddPCR, electrophoresis, ELISA, CE (CE-SDS, cIEF), and UV/VIS spectroscopy.
Responsibilities:
  • Routine Sample Testing and Data Analysis: 60%
  • Perform testing in support of process development and product release/stability
  • Maintain accurate and well-organized laboratory records
  • Generate technical reports using statistical analysis
  • Review and present analytical data to cross-functional teams
  • Method Development and Optimization: 20%
  • Develop analytical methods in support of process and product characterization
  • Troubleshooting of analytical methods to develop more robust workflows
  • Drafting of analytical Standard Operating Procedures
  • Reagent and Consumable Inventory Management: 10%
  • Maintaining the analytical lab reagents and consumables
  • Other Duties as Assigned: 10%

Qualifications:
  • MS degree in Biochemistry, Biology, or related field with 1+ year of pharma experience, or BS degree with 2+ years experience.
  • Experience:
  • 2+ years of Analytical Development Quality Control experience in the pharmaceutical industry desired
  • Experience with qPCR/ddPCR required
  • Pipette handling skills required
  • Experience with analytical method development and qualification under ICH guidelines desired
  • Experience or general knowledge of working with GxP documentation
  • Skills:
  • Sound understanding of scientific principles
  • General understanding of compendial testing, ICH qualification/validation
  • Experienced in PCR (qPCR, ddPCR) based analytics
  • Must be a team player, strong critical thinker, exhibit a willingness to meet project timelines and multitask effectively in a dynamic fast-paced environment under challenging timelines
  • Proficient or familiar with Microsoft based Windows programs: Word, Excel and PowerPoint 
  • Physical Requirements of the Role:
  • Prolonged periods of standing or sitting at the laboratory bench.
  • Frequent lifting (up to 25lbs.), bending, reaching, twisting.
  • During COVID-19, this person will need to be in the lab up to five days a week and adhere to the 4DMT Covid protocols and policy.

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran and any other category protected under applicable federal, state, provincial and local laws.\

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities