Senior Scientist, Analytical Development and Quality Control

2 months ago

Emeryville, California, 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 Senior Scientist to join our Analytical Development and Quality Control (ADQC) team. This individual will help lead the efforts for development of analytical procedures in support of product and process characterization. This position requires a strong background in analytical chemistry, molecular biology, or a related field, along with extensive experience in the biotechnology or pharmaceutical industry.

KEY RESPONSIBILITIES:

Develop, optimize, and validate analytical methods for the characterization and quality control of AAV vectors, including purity, identity, and advanced characterization.

Perform and oversee complex analytical testing techniques such as ddPCR, UPLC, capillary electrophoresis, and various spectroscopic methods.

Design and execute experiments to support process development, formulation development, and stability studies of AAV products.

Lead method transfer activities to internal and external laboratories, ensuring robust and reproducible performance.

Interpret and analyze data, providing clear and concise reports and presentations to cross-functional teams and stakeholders.

Mentor and provide technical guidance to junior scientists and laboratory staff.

Collaborate with colleagues in Research, Process Development, Quality Control, and Regulatory Affairs to ensure alignment and successful project outcomes.

Stay current with industry trends, regulatory guidelines, and advancements in analytical technologies, particularly those related to AAV gene therapy

QUALIFICATIONS:
Education & Experience:
Ph.D. in Analytical Chemistry, Molecular Biology, or a related field with 5+ years of relevant experience; or M.S. with 8+ years of relevant experience; or B.S. with 10+ years of relative experience in the biotechnology or pharmaceutical industry.

Proven expertise in developing and validating analytical methods for gene therapy products, particularly AAV vectors

Hands-on experience with a wide range of analytical techniques, including ddPCR, chromatography, electrophoresis, and spectroscopy.

Strong understanding of regulatory requirements and guidelines for analytical method development and validation (e.g., ICH, FDA, EMA).

Excellent problem solving skills and the ability to work independently and collaboratively in a fast-paced environment.

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.

Experience with the development of analytical methods in relation to biophysical and physiochemical characterization

Preferred Qualifications:
Experience with analytical method development for AAV vectors or other viral vectors.

Knowledge of statistical software and tools for data analysis.

Familiarity with automated and high-throughput analytical techniques.

Proficient with Microsoft based Windows programs: Word, Excel and PowerPoint

Compensation Range:
$164,000/yr - $194,000/yr
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

  • Head of Analytical Development and Quality Control

    1 day ago

    Emeryville, California, United States Tbwa ChiatDay Inc Full time

    Job SummaryWe are seeking an experienced and visionary leader to head our Analytical Sciences and Quality Control (ASQC) function. As the Head of Analytical Development and Quality Control, you will be responsible for developing and implementing phase-appropriate analytical methods and testing strategies for complex biologicals, including plasmid DNA, mRNA,...

  • Research and Development Scientist

    1 week ago

    Emeryville, California, United States Kelly Science, Engineering, Technology & Telecom Full time

    Job SummaryWe are seeking a highly skilled Research and Development Scientist to join our team at Kelly Science, Engineering, Technology & Telecom. As a key member of our R&D team, you will be responsible for developing and implementing new product formulations, leading cross-functional projects, and collaborating with suppliers to drive innovation and...

  • Analytical Scientist

    2 months ago

    Emeryville, California, United States Totus Medicines Full time

    This role provides exposure to multiple phases of drug discovery and development with a mission to characterize covalent small molecule-protein interactions and develop new sample workflows for chemoproteomics.Lead protein mass spectrometry campaigns across a multidisciplinary Platform Team in pursuit of enabling covalent drug discoveryPropose, implement,...

  • Junior Research Scientist

    2 weeks ago

    Emeryville, California, United States Planet Pharma Full time

    Position Overview:We are in search of a Junior Research Scientist who will play a pivotal role in the generation and refinement of antibodies and associated therapeutic proteins. This position is integral to our team, which is dedicated to advancing the field of bioconjugation.Work Environment:The role is based in a collaborative setting where scientists...

  • Product Development Specialist

    1 week ago

    Emeryville, California, United States Kelly Science, Engineering, Technology & Telecom Full time

    Job SummaryWe are seeking a highly skilled Research and Development Scientist to join our team at Kelly Science, Engineering, Technology & Telecom. As a key member of our product development team, you will be responsible for driving innovation and delivering high-quality products to the market.Key ResponsibilitiesDevelop and execute product development...

  • Research Scientist in Seismology

    2 weeks ago

    Emeryville, California, United States LBL Full time

    Position Overview:The Energy Geosciences Division (EGD) at LBL is seeking a Research Scientist specializing in seismology with a focus on energy-related projects, including geothermal energy and geological carbon storage. This role involves investigating the physics of subsurface dynamics, earthquake mechanisms, and the interplay between fluids and the solid...

  • Scientist II

    2 months ago

    Emeryville, California, United States 4D Molecular Therapeutics - (4DMT) 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...

  • Senior Manager of Cell Therapy Development

    6 days ago

    Emeryville, California, United States BeiGene Full time

    About the RoleWe are seeking an exceptional and highly motivated leader to join our Cell Therapy team at BeiGene. As the Director of Cell Therapy Operations, you will play a critical role in enabling the development of our cell therapy programs.Key ResponsibilitiesStrengthen our internal cell therapy capability by working with internal stakeholders and...

  • Senior SAP Finance Control Specialist

    2 weeks ago

    Emeryville, California, United States Tranzeal Incorporated Full time

    Position: SAP FI/CO Functional SpecialistCompany: Tranzeal IncorporatedOverview: We are seeking a knowledgeable professional with extensive experience in SAP Finance (FI) and Controlling (CO) modules to enhance our financial operations and drive process optimization.Key Responsibilities:Customize and configure SAP FI/CO modules to align with organizational...

  • Formulation Expert

    1 week ago

    Emeryville, California, United States Kelly Science, Engineering, Technology & Telecom Full time

    Job SummaryWe are seeking a highly skilled Research and Development Scientist to join our team at Kelly Science, Engineering, Technology & Telecom. As a key member of our product development team, you will be responsible for leading the development of new and innovative products.Key ResponsibilitiesDevelop and execute product development strategies to meet...

  • Associate Principal Research and Innovation Scientist

    1 day ago

    Emeryville, California, United States Post Holdings Full time

    Job SummaryThe successful candidate will be a technical expert in high protein ready-to-drink (RTD) product development. This scientist will be a key resource for our R&I teams to ensure robust technical understanding and validation of innovation.Key ResponsibilitiesProvide technical expertise in high protein RTD product developmentEnsure robust technical...

  • Senior Accounting Manager

    2 weeks ago

    Emeryville, California, United States Grocery Outlet Full time

    About Grocery OutletOur Mission: Touching lives for the betterOur Vision: Touching lives by being the first choice for bargain-minded consumers in the U.S.Our Values & Behaviors: Achievement, Diversity, Entrepreneurship, Family, Fun, Integrity & ServiceAbout The TeamThe Finance team is dedicated to enhancing operational efficiency while collaborating with...

  • Clinical Budget Development Specialist

    2 weeks ago

    Emeryville, California, United States BeiGene Full time

    About the RoleWe are seeking a highly skilled Clinical Budget Development Specialist to join our team at BeiGene. As an Associate Site Budget Development and Investigator Payment Management Expert, you will play a critical role in supporting the creation of site budget templates leveraging Fair Market Value (FMV) analysis.Key ResponsibilitiesDevelop Global...

  • Clinical Budget Development Specialist

    2 weeks ago

    Emeryville, California, United States BeiGene Full time

    About the RoleWe are seeking a highly skilled Clinical Budget Development Specialist to join our team at BeiGene. As an Associate Site Budget Development and Investigator Payment Management Expert, you will play a critical role in supporting the creation of site budget templates leveraging Fair Market Value (FMV) analysis.Key ResponsibilitiesDevelop Global...

  • Sr Research Associate

    2 months ago

    Emeryville, California, United States Kyverna Therapeutics Full time

    Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the...

  • Senior Accountant

    1 month ago

    Emeryville, California, United States Metagenomi Full time

    Metagenomi is a gene editing company committed to developing potentially curative therapeutics by leveraging a proprietary toolbox of next-generation gene editing systems to accurately edit DNA where current technologies cannot. Our metagenomics-powered discovery platform and analytical expertise reveal novel cellular machinery sourced from otherwise unknown...

  • Senior Inventory Operations Accountant

    2 weeks ago

    Emeryville, California, United States Peet's Full time

    Position OverviewThe Senior Inventory Operations Accountant plays a crucial role in driving initiatives focused on managing operational costs, overseeing inventory transactions, and supporting the goals of the Supply Chain Finance Department. This position reports directly to the Inventory Accounting Manager and involves a diverse workload, balancing...

  • Senior Manager of Food Manufacturing and Process Development

    6 days ago

    Emeryville, California, United States UPSIDE Foods Full time

    About the RoleThe Food MSAT Senior Manager will play a critical role in translating and integrating benchtop and pilot scale product development innovations into commercialized products at industrial scale. This position will be accountable for leading the design and development of food manufacturing processes for commercial launches, ensuring seamless...

  • Senior Brand Marketing Executive

    2 weeks ago

    Emeryville, California, United States Peet's Coffee & Tea Full time

    Senior Director of Brand MarketingWe are seeking a Senior Director of Brand Marketing who will be instrumental in guiding our organization towards a brand-focused approach. The successful candidate will lead the transformation of Peet's brand from a cherished local favorite to a nationally acknowledged leader in the industry.Oversee the creation of cohesive...

  • Senior Brand Marketing Executive

    1 week ago

    Emeryville, California, United States Peet's Coffee & Tea Full time

    Senior Director of Brand MarketingWe are seeking a Senior Director of Brand Marketing who will be instrumental in evolving our organization into a brand-focused entity. The successful candidate will lead the transformation of the Peet's brand from a cherished local favorite to a nationally esteemed leader in the industry.Oversee the creation of cohesive...