Sr Manager, QC

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:

The position of Sr Manager, QC, will lead the QC arm of our ADQC group, building out the QC team for late-phase product release and stability.  The successful candidate will be experienced with phase-appropriate development and validation of cell based and biochemical assays and will drive the stability program, as well as managing external collaborations (CRO, CDMO). This is a CMC and not R&D position. The position will have a strategic role in driving Phase 3 ready QC operations as well as a key operational role in day-to-day science and testing.

RESPONSIBILITIES:

• Lead the QC team on the execution, qualification/validation, trending, and troubleshooting of biochemical and cellular assays for AAV products.
• Lead the QC team for Phase 3 compliance activities, including instrumentation qualification and maintenance, LIMs system implementation and oversight,
• Responsibilities include stability oversight and management for multiple pre-clinical and clinical products
• Strong quality in a GMP background in managing deviations, NCRs, OOT, and other investigations is essential.
• Scientific leader who can interprets and tracks data and effectively communicates information or risk mitigation strategies that drive critical decisions in CMC department
• Authors technical reports and SOPs and authors relevant sections of regulatory filings and responses
• Manages and provides technical expertise as well as scheduling and training support to QC analysts in assay qualification, troubleshooting, as well as routine testing efforts
• Serves as a scientific liaison for outsourced assay development, technology transfer and data management in a CRO or CMO/CDMO environment

 

QUALIFICATIONS:

Education:

• PhD, MS, or BA in a relevant area of specialization (biological sciences, cell biology, molecular biology, virology), or equivalent in years of biotech experience

Experience:

• 5+ years of QC industry within the Biotech industry, preferably in a late-phase clinical or commercial environment. QC management experience is highly desirable.
• Demonstrated experience with building QC organization and/or managing early to late phase transitions is desirable.
• Experience in writing SOPs, developmental and technical reports, contributions to regulatory submission documents to support CMC efforts

Skills:

• 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
• Demonstrated history of working independently and leading teams while managing multiple projects
• Strong attention to detail supported by excellent time management and organizational skills
• Proficient or familiar with Microsoft based Windows programs: Word, Excel and Powerpoint as well as analytical software such as Softmax Pro and statistical software such as GraphPad, Minitab, JMP or Spotfire

Physical Requirements of the Role:  

• Primarily computer use and long periods of sitting, standing 
• To maintain a healthy and safe workplace for all during the COVID-19 this role is expected to adhere to 4DMT Covid protocols and policy. This includes all employees and contractors must share proof of current vaccination status to work onsite.  

Base salary compensation range:  

 

Minimum: 

Maximum: 

Bay Area Range 

$169,000 

$193,000 

 

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