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QC Manager

4 months ago

Emeryville, United States 4D Molecular Therapeutics Full time

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future.

 

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 seeking a highly skilled and motivated Quality Control Manager to join our Analytical Development and Quality Control (ADQC) team. The QC Manager (External Testing) will be responsible for overseeing external activities related to release and stability of our AAV production. This includes managing relationships with contract manufacturing organizations (CMOs) and contract testing organizations (CTOs), ensuring compliance with regulatory standards, and implementing robust quality control processes. The ideal candidate will have extensive experience in QC management within the biopharmaceutical industry, particularly with AAV gene therapy products.  

KEY RESPONSIBILITIES:  

Oversee and manage all external QC activities related to product release.  Establish and maintain strong relationships with CMOs and other external partners.   Coordinate and manage the transfer of QC methods to CMOs.  Ensure that external activities are conducted in compliance with regulatory requirements and company standards.  Help develop, implement, and maintain QC policies and procedures to ensure compliance with FDA, EMA, and other relevant regulatory guidelines.  Conduct regular audits of CMOs and external laboratories to ensure adherence to quality standards.  Review and approve QC-related documentation, including SOPs, test methods, validation protocols, and reports.  Analyze QC data and trends to identify potential quality issues and implement corrective actions.  Prepare and present QC performance reports to senior management.  Ensure accurate and timely documentation of all QC activities and results.   Collaborate with internal teams, including Quality (Control/Assurance), Manufacturing, and Regulatory Affairs, to ensure alignment on quality objectives.   Serve as the primary point of contact for external QC-related inquires and issues.  

QUALIFICATIONS: 

Education & Experience: 

Degree in Analytical Chemistry, Molecular Biology, or a related field with 5+ years of experience in Quality Control within the biopharmaceutical industry.   Extensive experience with AAV vectors and gene therapy products is highly desirable.   Proven experience managing external QC activities and working with CMOs.  Strong understanding of regulatory requirements and guidelines for analytical method development and validation (e.g., ICH, FDA, EMA).   Experience with lab investigations is highly preferred  Strong analytical and problem-solving skills.  Excellent communication and interpersonal skills.  Detail-oriented with a strong focus on quality and compliance.    Proven expertise in developing and validating analytical methods for gene therapy products, particularly AAV vectors  Strong organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.   Effective communication skills, both written and verbal, with the ability to convey complex technical information to diverse audiences.  

Preferred Qualifications: 

Knowledge of statistical software and tools for data analysis.  Proficient with Microsoft based Windows programs: Word, Excel and PowerPoint  

Base salary compensation range:

$139,000/yr - $166,000/yr

Salary varies on a variety of factors including experience, location, and other factors  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