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Scientist, Analytical Development & Quality Control

Employer
4D Molecular Therapeutics
Location
Emeryville, California
Start date
Jan 23, 2024

View more

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

Job Details

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

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 Scientist I 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 Scientist I in Analytical Development/Quality Control (ADQC) (QC focus) is responsible for authoring technical reports and protocols, 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, AUC, Biolayer Interferometry (BLI), 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: 30% 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 
  • Support the authoring and review of CMC sections of INDs 
  • Identify gaps and mitigate impact when industry guidelines or pharmacopeia sections are updated 
  • Train colleagues in areas of expertise  
  • Perform testing in support of process development 
  • Evaluate results against defined acceptance criteria 

Method Qualification and Validation: 40% of TIME 

  • Implementation of phase-appropriate test methods and specifications. 
  • Identify trends that drive method requirements and ensure methods are fit for purpose 
  • Provide technical guidance as subject matter expert to QC staff 
  • 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) 
  • Author technical documents for reference material qualification studies 
  • Lead 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: 

  • Ph.D. in a relevant scientific field; MS Degree or Bachelor of Sciences degree in a technical discipline (Biochemistry, Biology, or related field) is required.    

Experience: 

  • 8+ years of relevant hands on GMP laboratory experience in the pharmaceutical industry. 
  • 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. 
  • Experience with CMC activities for clinical programs. 
  • Strong regulatory and GMP acumen. 

 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:

Bay Area-based candidates: $128,000/yr. - $149,000/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

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
Phone
510-505-2680
Location
5858 Horton St. Suite 455
Emeryville
California
94608
United States

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