Director – Assay and Bioanalytical Development
Location: South San Francisco, CA
Ambys Medicines is a biotechnology company focused on discovering and developing regenerative and restorative therapies for people with advanced liver disease. Founded by world-renowned experts in liver disease and regenerative medicine, Ambys is pioneering the application of novel modalities including cell and gene therapy, and gain-of-function drug therapy, to meet the urgent need for treatments that have the potential to restore liver function and prevent the progression to liver failure across multiple liver diseases that are untreatable or poorly treated today. Ambys was launched in 2018 by Third Rock Ventures and Takeda Pharmaceuticals with $140M in starting capital and is headquartered in South San Francisco, Calif.
Ambys is seeking a talented and motivated Director of Assay and Bioanalytical Development. The individual will be responsible for the development and optimization of assays required to support Ambys’ multimodal approach for the treatment of patients with severe liver disease. This person should have extensive experience in assay and bioanalytical development, sample processing, assay qualification, and data presentation. Strong candidates will be highly organized and have the self-confidence to work across boundaries. The position will report to the CSO and serve as the leader for the assay and bioanalytical function on different project teams, providing technical and strategic input for assay development efforts to ensure rapid and high-quality execution of biochemical and molecular assays. Candidates should enjoy working in a fast-paced dynamic team environment and be motivated to develop new breakthrough therapies for patients with severe liver disease.
- Organize and lead a high-quality and functioning assay and bioanalytical team
- Oversee the development, testing, analysis and review of results for early research and IND-enabling studies.
- Demonstrate an ability to prioritize, coordinate, and deploy assay development efforts across company platforms (cell therapy, gene therapy and small molecule) for sample processing and analyses from multiple concurrent studies.
- Provide technical leadership, expertise and mentorship to direct reports for vector and cell-based analytics, method optimization, qualification and routine testing.
- Display an ability to navigate assay development requirements as programs progress through stages of drug development
- Deep understanding of wide range analytical and bioanalytical testing methods including but not limited to qPCR for biodistribution of gene therapy vectors and cell therapy products, ELISA, FACS, gene expression profiling by RT-qPCR and RNAseq, Western Blots, biochemical assays, and variety of cell-based assays (AAV TCID50, Nab, and program-relevant potency assays) to support our three platform approach.
- Keep current with advances in assay and bioanalytical methodologies, including strategies to aid clinical translation or expand Ambys’ core technologies and discovery engine
- Identify and collaborate with external CROs to support assay development and sample testing to meet timelines for nonclinical studies
- Review and finalize assay reports to ensure scientific validity and regulatory requirements, and author IND sections related to bioanalytical methods and sample analysis
- Commit to help the team provide deliverables and meet aggressive timelines
- Organize, communicate, and present complex data sets to senior management and key stakeholders
- PhD in biological sciences such as biochemistry, immunology, or cell and molecular biology is required
- 10 plus years of experience in the biotechnology or pharma industry with 8 plus years of increasing responsibility in managing and leading a team to meet project goals and timelines
- Direct experience in assay development, qualification, and validation in support of developing cell and gene therapy products with a proven track record to support interpretation of results
- Demonstrated ability to work innovatively and efficiently while managing multiple projects, scientists, and research associates
- Proven ability to work with a high level of integrity, accuracy and attention to details; supported by excellent time management and organizational skills
- Strong communication and interpersonal skills to influence effectively across the organization and with CROs
- Experience with the set-up, technology transfer and execution of assays at CROs
- Excellent writing and editing skills are essential, including highly developed computer skills using Microsoft Word, Excel, PowerPoint, SoftMax Pro and Graph Pad Prism
- Fundamental understanding of statistical analyses for analytical and bioanalytical assay development
- Experience preparing documentation for regulatory filings with US and/or EU regulatory agencies
- Demonstrated technical and strategic leadership and problem-solving skills
- Experience presenting complex concepts to all levels of the organization, with proven ability to clearly articulate a point of view and recommendation
- Ability to lead a team and mentor individuals to achieve organization, team and individual objectives while adhering to the company values (accountability, collaborative)
- Expertise in staffing, budgeting and expense management
If you would like to be considered for an opportunity at Ambys Medicines, please submit your CV with the title of the position in the subject line to email@example.com
The well-being of our employees and their families is important to us. We offer comprehensive and competitive health, financial, paid time off and many other benefits designed to promote the health and financial well-being of our employees and their families.
Note to Recruitment Agencies: Please do not forward any agency resumes. Ambys Medicines is not responsible for any fees related to resumes that are unsolicited.
Ambys Medicines is an equal opportunity employer.