Azzur Labs is seeking a Sr. Director of their Raleigh North Carolina Laboratory. 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. Applicant should have a broad diversity of experiences in biotech and pharmaceutical laboratory management. Preferred experience in a fast-growing dynamic environment.
- Set strategic direction for the Practice including short- and long-term goals.
- Develop business by establishing and maintaining positive relationships with new and existing clients.
- 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:
- 10+ years in a regulated, laboratory environment within the biotechnology, pharmaceutical, or medical device industry.
- 5+ years life science compliance(microbiology).
- 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)
- Pinnacle Q-PCR™ assay
- AUC for empty/full capsid
- Vector identification by qPC
- ddPCR (genomic titer)
- 3+ years’ experience in business management, planning, and financial oversight
- 3+ years’ experience in personnel management, including hiring, supervision, and evaluation
- Experience in A GMP microbiological laboratory, compendia testing and compliance with USP, FDA, ISO AAMI and AOAC is required.
- Experience with gene and cell therapy test methodologies (PCR, Flow Cytometry, ELISA, Mycoplasma and cell-based assays)
- Proven and established HLS network in a designated region
- Prior experience as director/operations manager / or project manager
- Outstanding people skills
- Prior sales/customer service experience.
- BS degree in Engineering, Science, or equivalent technical degree