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Senior Manager, Bioanalytical Outsourcing
3 months ago
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
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
