Molecular Biology, Analytical Lead
Location: RTP, North Carolina
HireMinds is seeking your expertise in molecular biology analytical testing to lead a team in the development and execution of Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) assays. You’ll have experience with experiment oversight within a Good Manufacturing Practices (GMP) laboratory environment. This role is part of a larger effort to support advanced cell and gene therapy testing with clinical phase biopharma partners. You’ll work with a growing team in a new for 2025 site in the RTP area.
You’ll Be Responsible For:
- Leading a lab team of scientists focused on molecular biology assays.
- Oversee and coordinate daily lab operations, ensuring efficient workflows.
- Leverage expertise in method development, validation, and transfer for PCR and NGS, adhering to GMP standards.
- Perform data reviews, troubleshoot complex assays, and manage critical GMP cases.
- Manage multiple projects simultaneously, ensuring timely delivery of high-quality analytical results.
- Serve as the primary point of contact for clients, providing updates on project progress and addressing technical demands
- Train and mentor team members, providing performance evaluations, and professional development.
- Ensure compliance with regulatory requirements and internal SOPs.
- Serve as the primary liaison during customer audits and regulatory inspections.
- Review and approve lab documentation, including protocols, reports, and lab notebooks.
- Conduct investigations related to GMP deviations, non-conformities, and other quality events.
- Assist in the creation of analytical proposals and contribute to process improvements.
- Supervise lab inventory management, supply orders, and instrument maintenance.
- Collaborate effectively with cross-functional teams to support project goals.
You’ll Bring:
- M.S. or Ph.D. in Life Sciences with 7+ years of relevant experience, or B.A./B.S. with 12+ years of relevant experience.
- Proven leadership experience in a laboratory setting.
- Strong project management and client management skills.
- Hands-on experience in GMP or GLP environments.
- Hands-on Expertise in the development, validation, and execution of qPCR, ddPCR, and NGS assays, with knowledge of emerging molecular technologies.
- Ability to work in regulated GMP environment with mind to quality standards in all daily lab duties.