Sr. Research Associate, Analytical Development & Quality Control
4D Molecular Therapeutics
At 4D Molecular Therapeutics, Inc. (“4DMT”), we boldly innovate to unlock the full potential of genetic medicines for countless patients. We are committed to breaking boundaries and daring to cure as we develop new and foundational products and product components through our growing technology platforms.
4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.
We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia. In addition, we have two product candidates in preclinical studies: 4D-175 for geographic atrophy (GA) and 4D-725 for alpha-1 antitrypsin deficiency.
To-date, we have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations. We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors. We have built a robust and efficient product engine with 6 open Investigational New Drug Applications (INDs) in the U.S., 1 IND in Taiwan, and 1 Clinical Trial Approval (CTA) in Australia. We believe we are positioned to create, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases.
In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material. This internal capability and close collaboration between our R&D and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT.
Company Differentiators:
• Fully integrated clinical-phase company with internal manufacturing
• Demonstrated ability to move rapidly from idea to IND
• Five candidate products in the clinic and two declared pre-clinical programs
• Robust technology and IP foundation, including our TVE and manufacturing platforms
• Initial product safety and efficacy data substantiates the value of our platforms
• Opportunities to expand to other indications and modalities within genetic medicine
GENERAL SUMMARY:
We are a high-performing, innovative, team-based organization, where collaboration, flexibility, initiative, energy, and motivation is essential. Reporting to the Senior Manager of ADQC, the primary role of the Senior Associate in Analytical Development/Quality Control (ADQC) is to provide support to clinical programs by providing quality testing and delivering results in accordance with cGMP standards. Ensuring our products are safe for patients and fit for purpose.
The Senior Associate in Analytical Development/Quality Control (ADQC) (QC focus) is responsible for performing routine analytical testing, data analysis, method qualification and method validation. The candidate will work closely with Process Development, Manufacturing, and Quality organizations to support raw material, in-process, release, and stability testing onsite. 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. The successful candidate with have working knowledge of cGMP testing regulations.
RESPONSIBILITIES:
Routine Sample Testing and Data Analysis: 50% of TIME
- Perform testing of raw material, in-process, release and stability samples under cGMP
- Maintain accurate and well-organized laboratory records
- Perform primary review of QC raw data and trend results
- Draft technical reports using statistical analysis
- Review and present analytical data to cross-functional teams
- Author QC SOPs and complete change control
- Train colleagues in areas of expertise
- Perform testing in support of process development
- Evaluate results against defined acceptance criteria
- Ship samples to contract test sites
Method Optimization and Qualification: 20% of TIME
- Transfer, optimize and trouble-shoot analytical methods for use in Quality Control
- Draft analytical method Standard Operating Procedures
- Draft protocols and reports in support of analytical method qualifications.
- Execute testing in support of analytical method qualification and validation.
Quality System Oversight: 30% of TIME
- Maintain a cGMP compliant testing laboratory
- Perform equipment PMs, and manage equipment calibration documentation
- Support implementation of new Laboratory Information Management System (LIMS)
- Organization and maintenance of reference materials
- Conduct and document laboratory investigations
- Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
QUALIFICATIONS:
Education:
- MS degree in Biochemistry, Biology, or related field with 3+ years of experience or BS degree with 5+ years of experience
Experience:
- 2+ years of Quality Control experience in the pharmaceutical industry desired.
- Strong background in assay qualification/validation under ICH Guidelines.
- Knowledge of viral gene therapy (adeno associated viral vectors) preferred.
- Ability to work independently and work with others in designing and developing experiments, analyzing, and interpreting data in a rigorous way.
- Ability to multi-task and support more than one project simultaneously.
- Understanding and knowledge of key scientific software programs (SoftMax, QuantaSoft, etc.)
- Understanding and knowledge of regulatory requirements for biologic products and cGMPs.
- Strong organizational, analytical, and problem-solving skills.
- Strong communication skills both written and oral with demonstrated ability to present ideas and information and data effectively via one-on-one discussions, team meetings and partnership interactions.
- Comfort with quality and accuracy of delivery in GMP documentation.
Skills:
- Sound understanding of scientific principles.
- General understanding of compendial testing, ICH qualification/validation.
- 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.
Base salary compensation range:
| Minimum: | Maximum: |
Bay Area Range | $105,000 | $125,000 |
Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.