Sr. Research Associate, ADQC

Employer: 4D Molecular Therapeutics
Location: Emeryville, California
Start date: Nov 9, 2022

Discipline: Regulatory, Research/Documentation, Science/R&D, Research
Required Education: Bachelors Degree
Position Type: Full time
Hotbed: Biotech Bay, Best Places to Work

Job Details
Company

Job Details

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 has five active clinical trials: 4D-150 is a Phase 1/2 clinical trial for Wet AMD, 4D-125 is in a Phase 1/2 clinical trial for XLRP, 4D-110 is in a Phase 1 clinical trial for Choroideremia, 4D-310 is in a Phase 1/2 clinical trial for Fabry disease and 4D-710 is a Phase 1/2 clinical trial for Cystic Fibrosis. 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 Senior Associate in Analytical Development/Quality Control (ADQC) (QC focus) is responsible for performing routine analytical testing, data analysis, and method optimization/qualification. The candidate will work closely with Process Development, Manufacturing, and Quality organizations. 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.

Responsibilities

Routine Sample Testing and Data Analysis: 40% of TIME

Perform testing in support of process development
Perform testing for release and stability under GMP
Maintain accurate and well-organized laboratory records
Generate technical reports using statistical analysis
Review and present analytical data to cross-functional teams

Method Optimization and Qualification: 30% of TIME

Transfer and optimization of analytical methods for use in Quality Control
Drafting of analytical Standard Operating Procedures
Drafting, execution, and reporting of analytical method qualifications

Quality System Oversight: 20% of TIME

Maintaining a GxP-compliant testing laboratory
Coordination and planning of Stability Testing
Organization and maintenance of reference materials

Other Duties as Assigned: 10% of TIME

Qualifications

MS degree in Biochemistry, Biology, or related field OR
BS degree with 3+ years of experience
Experience working within Quality Control within a regulated industry
Strong background in assay qualification/validation under ICH Guidelines
Knowledge of viral gene therapy (adeno-associated viral vectors) preferred
Successful demonstrated 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 such as SoftMax/QuantaSoft
Understanding and knowledge of regulatory requirements for biologic products
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
Experience working under GXP 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, a 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

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 Attention: Search Firms / 3rd Party Recruitment Agencies* The Talent Acquisition / HR team manages the recruiting for all positions at 4D Molecular Therapeutics. We will only accept resumes from a search agency/recruiter if we have a signed agreement in place and the Talent Acquisition / HR team has formally requested your help on a specific role. Unsolicited resumes sent to 4D Molecular Therapeutics will be considered property of 4D Molecular Therapeutics. 4D Molecular Therapeutics will not be responsible for any fees associated should we hire from unsolicited resumes. Recruiters are requested not to contact or present candidates directly to our hiring managers or employees, and doing so may jeopardize eligibility to work on future positions. Recruiters interested in working with 4D Molecular Therapeutics can submit their information to recruiting@4dmt.com– should we have a tough-to-fill role, we will contact you directly if you specialize in that area.

Company

4DMT is a gene therapy company with a transformative discovery platform --Therapeutic Vector Evolution --that enables our “disease first” approach to product discovery and development, thereby allowing us to customize our AAV vectors to target specific tissue types associated with the underlying disease.

At 4DMT we are creating and developing optimized “biopharmaceutical grade” AAV vectors that will allow us uniquely to unlock the full potential of gene therapy. Our customized and proprietary AAV vectors are each designed, according to a 4DMT Target Vector Profile, to deliver genes to specific cells and tissues in the body to eradicate both rare and large market diseases.

While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of conventional vectors. The most commonly used AAV capsids (e.g., AAV2, 5, 8 and 9) were identified either 1) as contaminants in lab stocks of adenovirus, or 2) through monkey tissue processing. Therefore, these conventional vectors are not targeted specifically to any tissue in the body. This can lead to inefficient and non-specific delivery, thus requiring extremely high doses and potentially resulting in toxicities (including inflammation), high manufacturing burdens and suboptimal efficacy. In addition, suboptimal routes of delivery can be required for delivery to the right tissues (e.g., subretinal delivery to the retina). Finally, pre-existing neutralizing antibodies in many patients can limit efficacy, clinical trial enrollment and market sizes. 4DMT Innovation empowers us to create new and improved next generation AAV capsids to allow targeted delivery of our products by the optimal clinical route of administration.

At 4DMT we use our robust discovery platform, termed “Therapeutic Vector Evolution,” to create customized and proprietary gene delivery vehicles (novel AAV vectors) to deliver genes to specific tissues and cells in the body by the optimal route of administration. We use the power of evolution to create and refine these optimized vectors through genetic diversification and then natural selection in vivo.

4D Purpose Statement: Boldly Innovating to Unlock the Full Potential of Gene Therapy for Countless Patients

GUIDING PRINCIPLES

Dare to Cure - Patients are waiting. Create big dreams for patients and take calculated risks to achieve them
Break Boundaries - Question the status quo and innovate beyond conventional approaches
Beyond Yourself - It's about patients, their families, our team, our families. We strengthen each other.
Prepare and Execute Relentlessly - Start with the end in mind, over-prepare and make contingency plans to your contingency plans

We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure genetic and rare diseases in children and adults. We seek 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 generous benefits and provides challenging opportunities for career development.

Company info

Website: http://www.4dmoleculartherapeutics.com/
Phone: 510-505-2680
Location: 5858 Horton St. Suite 455
Emeryville
California
94608
United States

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