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Senior Manager, Bioanalytical Outsourcing

Employer
4D Molecular Therapeutics
Location
Emeryville, California
Start date
Aug 26, 2024
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Job Details

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly 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.  

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

The Senior Manager, Bioanalytical Outsourcing, will be in the Biomarkers & Immunology group. The group supports immunogenicity monitoring, pharmacokinetic evaluations, biomarker measurements, and exploratory research by developing new bioanalytical methods. These methods are rigorously qualified or validated at external contract research organizations (CROs) to characterize their performance.

This position will report to the Senior Director of Biomarkers & Immunology and independently manage CROs. 

PRIMARY RESPONSIBILITIES:

  • Assessing the utility of contract research organizations (CROs), managing technology transfer, and overseeing outsourced bioanalytical method validation and production
  • General areas of bioanalytical methods will be in ligand-binding, cell-based and molecular assays, and mass spectrometry that are used to evaluate immunogenicity, PK/PD, biodistribution, and biomarkers
  • Initiating requests for proposals (RFPs), reviewing and negotiating scopes of work (SOWs), and comparing bids from different bioanalytical vendors
  • Managing legal review of master service agreements and contracts, requesting purchase orders (POs), and providing budgetary oversight
  • Ensuring appropriate scientific approaches are used to understand the characteristics of bioanalytical methods
  • Monitoring method performance using statistical tools to predict adverse trends
  • Designing method validation experiments, analyzing validation and study data using next-gen analytical techniques, and presenting data to line management and study teams
  • Providing oversight of clinical study samples, bioanalytical testing plans, and batch testing schedules at CROs
  • Perform continuous quality control (QC) review of CRO-generated study and method validation data
  • Supporting the preparation of content for regulatory interactions and submissions (e.g. pre-IND Briefing Books, IND/BLA filings, Orphan Drug Designation, EMA submissions)
  • Maintaining current awareness of scientific literature and regulatory guidance
  • Writing and reviewing technical documents and study reports, supporting manuscripts and presenting results at scientific meetings
  • Maintaining compliance with company Environmental Health and Safety policies, procedures, and practices
  • Contributing to building a culture that embraces continuous learning, improvement, and innovation and encourages team members to expand their technical skill base and deepen their gene therapy expertise.

QUALIFICATIONS:

Education & Experience:

  • Degree in Immunology, Bioengineering, Molecular Biology, Cell Biology, Pharmacology, Biochemistry or related field
  • With a PhD – 8+ years of experience (5+ years in industry), Master’s degree with 10+, Bachelors with 12+ years
  • Strong scientific acumen as demonstrated by publications in peer-reviewed scientific journals and ability to work in a matrixed environment
  • Experience on cross-functional teams and work in a scientific or clinical setting supporting drug development
  • Experience with bioanalytical, immunogenicity, and/or biomarker assay development and validation
  • Experience selecting and efficiently managing CROs
  • Experience with AAV gene therapy

 

Skills:

  • Successfully demonstrated ability to work independently in designing, developing, validating, and executing new assay methods
  • Successfully demonstrated ability to conduct research with strong attention to detail and rigorously analyze and interpret immunogenicity and biomarker data
  • Proficiency with statistical concepts used to establish immunogenicity assay cut points, determine limits of detection, and monitor method performance (trending)
  • Working knowledge of GLP (21 CFR Part 58) and GCLP principles as they relate to bioanalytical method validation and regulated sample analysis
  • Working knowledge of FDA, EMA, and ICH guidance relevant for immunogenicity assessment, bioanalytical method validation, and gene therapy development
  • Competence in using standard microplate readers, MesoScale Discovery instruments, as well as protein labeling, detection, and purification techniques
  • Experience with tissue culture of primary cells and established cell lines
  • Familiarity with the fundamentals of qPCR, ddPCR, and LC-MS method validations would be a plus
  • Ability to multi-task and support more than one project simultaneously
  • Highly organized and motivated; strong analytical, organizational, and problem-solving skills; strong work ethic, flexibility, and cooperative can-do attitude
  • Ability to work cooperatively in a team-based environment; supportive of multiple viewpoints and approaches
  • Strong communication skills (both written and oral) with demonstrated ability to present ideas, information and data effectively via one-on-one discussions, team meetings, and external partnership interactions
  • Understanding and knowledge of key scientific software programs (including Microsoft Office, JMP or Prism, Adobe Photoshop).

 

Base salary compensation range: $160,000/yr - $195,000/yr

Please note: the base salary compensation range and actual salary offered to the final candidate depends on various factors: relevant work experience, skills, and years of experience

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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