Department: Azzur Labs, LLC
Azzur Labs is seeking a Sr Director Lab for the San Francisco location. This person will be responsible for the overall business results of the laboratory and service area. Core responsibilities include sourcing and winning new business, attracting and retaining people, managing finances and operations, and assuring compliance with governing agencies and client specifications. Applicants should have a broad diversity of experiences in biotech and pharmaceutical laboratory management.
- Develop a comprehensive strategic plan with the key functional leaders, including target market, technology acquisition, competitive landscape, client acquisition, and business development initiatives for advanced therapies such as Cell and gene therapy, RNA therapeutics, etc.
- Develop forecasting, trends, revenue modeling, and financial risk analysis of business opportunities in the cell and gene therapy industry
- Communicate vision and strategic plan to key stakeholders.
- Establish clear milestones, organize teams to support the revenue pipeline, and assist with client acquisition.
- Work with key functional leaders to complete the opportunity assessment, due diligence, valuation, negotiating strategy, deal structure, and negotiations for key initiatives.
- Develop and manage a robust pipeline of deals and partnerships. Comprehensive business and financial assessment of new technologies
- Build analytical models and perform financial analyses, comprehensively value opportunities, provide clear explanations, and make well-founded recommendations to top management.
- Support the attraction, hiring, development, and retention of skilled resources for the delivery of services
- Manage and maintain revenue and profitability, as defined on an annual basis
- Manage service execution by providing subject matter expertise, overseeing employee productivity and quality, and providing hands-on support, if needed
Required Work Experience:
- Expert-level knowledge of CMC analytical and regulatory requirements, including the development of product specifications and comprehensive analytical characterization.
- Significant experience in laboratory operations, including budgeting, capital expense procurement, and regulatory requirements.
- 10+ years in a regulated laboratory environment in the biotechnology, pharmaceutical, or medical device industry.
- 5+ years of experience in Plasmid Monitoring, vector integration, residuals, mycoplasma, in vitro assays for adventitious viruses, qPCR, PERT,
- 3+ years in Replication competent virus assay for lentivirus, adenovirus, AAV, etc.
- Droplet digital PCR (ddPCR)
- PinnacleQ-PCR™ assay
- AUC for empty/full capsid
- Vector identification by qPCR
- ddPCR (genomic titer)
- Proven and established HLS network
- Outstanding people skills
- Prior sales/customer service experience.
- BS degree in Engineering, Science, or equivalent technical degree
- D., MSc/MA/MBA