- Responsible for the laboratory's delivery of high-quality science by providing subject matter expertise, overseeing technical execution, quality assurance, and providing hands-on support.
- Collaborating with Sales and Business Development to win and maintain positive relationships with new and existing clients.
- Supporting the attraction, hiring, development, and retention of skilled resources for the delivery of services
- Managing and maintaining revenue and profitability, as defined on an annual basis (i.e., the profit and loss (P&L))
- Contributing to planning the strategic direction for the lab, focusing on future business growth
- Collaborate with other regional offices or functional areas on shared clients and needs (such as multi-site companies/clients, GMP Library, and audits)
- Translate new and existing client needs into actionable value-added projects/results.
- Prepare capability presentations, proposals, and agreements for new and existing clients.
- Monitor and report the status of projects and key performance indicators as needed.
- Develop annual forecasts and track and report on progress quarterly.
- Develop business revenue and profitability projections and monitor/correct performance.
- 10+ years in regulated environment within the biotechnology, pharmaceutical, or cell and gene therapy (CGT) industries
- 5 years of experience with gene and cell therapy test methodologies (PCR, Flow Cytometry, ELISA, Mycoplasma and cell-based assays)
- 5+ years of experience in Plasmid Monitoring, vector integration, residuals, mycoplasma, in vitro assays for adventitious viruses, qPCR, PERT.
- 5+ years working in laboratory testing within a life science organization.
- 3+ years of experience in business management, planning, and financial oversight
- 3+ years of experience in personnel management, including hiring, supervision, and evaluation.
- Demonstrated experience in performing established microbiological methods such as USP 797, 61, 62, sterility, endotoxin, TOC, and environmental monitoring.
- Experience with multi-color flow detection assays and cell-based potency assays for lot-release and characterization purposes.
- Proven and established healthcare life sciences (HLS) network in a designated region
- Experience with sterile culture technique, cell preservation studies, and subsequent analytical assessment platforms for both drug substances and drug products.
- Experience with client-facing tech transfer process and internal and external analyst training.
- Business management experience across multiple business lines
- Experience in business development, profit and loss (P&L) management, and budgeting
- Strong understanding of FDA and cGMP regulations and documentation practices
- Knowledge of GMP, GxP, ICH, and 21 CFR part 11 regulations relevant to a QC lab operation.
- Knowledge of the develop and qualification of various stability-indicating, cell-based, potency assays for both lot-release and product characterization of cell and gene therapy drug products
- Well-versed in different analytical instruments such as flow cytometers, multi-mode plate readers, stemVisionTM, MSD, ProteinSimple units, and use of 3rd party data analysis software
- BS degree in Biology, Microbiology, Molecular Biology, or equivalent technical degree and/or industry experience
- Flexible PTO
- Training and Development Opportunities
- 401(k) match
- Bonus Eligibility
- Medical Benefits
- Paid Holidays
- Company provided laptop
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Senior Director of Laboratory services - Cary, United States - Azzur Group
Description
Azzur Lab is actively searching for a Senior Director of Lab services to serve as the site lead for our laboratory facility in Raleigh, NC. The ideal candidate will be a cross-functional leader capable of overseeing our Advanced Therapies and Microbiology teams. Core responsibilities of this role include overall site leadership, collaborating with sales and business development to win new business, attracting and retaining people, managing finances and operations, and contributing to the strategic direction of the site.
Responsibilities:
Founded in 2012, Azzur Labs is a contract laboratory that serves the pharmaceutical, medical device and biotechnology industries. We believe that the world of research is always on the brink of amazing discoveries and advances that will allow us to live healthier and happier lives. Our goal is to help these companies move from the drug discovery phase to delivery by supporting their microbiological and analytical testing and ensuring regulatory compliance.
From Discovery to DeliveryTM, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. From Azzur Cleanrooms on DemandTM facilities, to our labs, training centers and consulting offices across the nation, Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the world's leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain. Azzur Group provides clients with the consulting, facility solutions, engineering, validation, IT, technical, training, and laboratory services and solutions they need to remain innovative and competitive.
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