Associate Scientist, Analytical Development

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 Associate Scientist in Analytical Development/Quality Control (ADQC) is responsible for performing routine analytical testing, data analysis, and method development/qualification. The successful candidate will be able to lead and support research initiatives such as new technology development and continuous improvement projects. The candidate should be able to demonstrate innovative design, development and execution of analytical projects through literature review and scientific teamwork. Leverages strong understanding of analytical biochemistry, including DNA-based assays (qPCR/ddPCR/NGS) and/or protein-based assays (HPLC/CE/ELISA) from early development through qualification/validation. The candidate will work closely with Process Development, Research, and Quality organizations. 
Responsibilities
  • Routine Sample Testing and Data Analysis: 50%
  • 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
  • Manages quality events such as lab investigations and CAPAs
  • Method Development, Optimization, and Troubleshooting: 40%
  • Develop analytical methods in support of process and product characterization
  • Work closely with the process development teams to incorporate analytical procedures required to characterize incoming processes
  • Write assay development reports, assay qualification and validation protocols and reports, and regulatory documents
  • Provide guidance to lower-level associates in the development of analytical procedures
  • Drafting of analytical Standard Operating Procedures using GxP documentation practices
  • Other Duties as Assigned: 10%

Qualifications:
  • PhD (Biochemisty, Bioengineering, Biology or related field) with 2+ years experience, MS degree in Biochemistry, Biology, or related field with 5+ years experience, or BS degree with 5+ years experience in analytical development/quality control
  • Experience:
  • Candidate must have a strong background in standard analytical techniques
  • In-depth knowledge of GMP biotechnology manufacturing
  • Strong background in assay qualification/validation (ICH Guidelines)
  • Working knowledge of Quality Control workflows highly desired
  • Experience or general knowledge of working with GxP documentation required
  • Provide support of process changes by utilizing analytical data
  • Experience with regulatory documentation
  • Skills:
  • Identification of critical quality attributes (CQA) for which controlled assays must be available for lot release and stability, and other attributes that require characterization assays
  • Experienced in PCR (qPCR, ddPCR, NGS) based analytics
  • Knowledge of viral gene therapy (AAV) preferred
  • Ability to multitask and support more than one project at a time
  • Successful demonstrated ability to work independently and lead others in designing and developing experiments, analyzing and interpreting data in a rigorous way
  • Understanding and knowledge of key scientific software programs
  • Understanding and knowledge of regulatory requirements for biologic products
  • Strong verbal and written communication skills and effective interpersonal, technical discretion and troubleshooting skills are essential
  • 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