Director - Bioanalysis

At the cutting edge of genetic transformation, this company is dedicated to reshaping lives. Established as a pioneer in clinical-stage gene therapy in 2001, their commitment to innovation is unwavering. With a portfolio enriched by therapeutic programs, unmatched AAV manufacturing, and groundbreaking patented technology, their core therapeutic focus is broad, spanning neuromuscular, central nervous system, cardiovascular, and metabolic diseases.

Being part of this organization means integrating with a global entity, a part of an expansive network with international operations. As of 2020, they proudly stand as a pivotal entity under a globally renowned conglomerate.

Now, a unique opportunity arises at their Research Triangle Park hub for a Director of Bioanalysis.

Your role as Director, Bioanalysis:

• Lead and mentor the bioanalysis sub-team, ensuring timely and efficient support for both non-GLP and GLP studies.
• Craft and strategize bioanalysis roadmaps tailored for therapeutics at various development stages.
• Ensure stringent compliance with internal procedures, in line with FDA, EMA, and other regulatory standards.
• Drive advanced bioanalytical projects, ensuring that data interpretations set industry benchmarks.
• Oversee the methodological framework of bioanalysis, upholding the utmost quality at every phase.
• Critically evaluate clinical study protocols, ensuring they meet regulatory guidelines.
• Author and meticulously review assay validation protocols and reports.
• Serve as the primary authority for bioanalytical assay strategies, fostering robust CRO collaborations.
• Continually innovate systems, ensuring the highest standards of quality and efficiency across all bioanalytical support functions.
• Provide hands-on mentorship, fostering the growth of research associates and emerging scientists.

Experience and qualifications for the Director, Bioanalysis role:

• A PhD or Master's degree in biochemistry, cell biology, molecular biology, or a related field.
• A significant background in a regulated bioanalysis setting, predominantly in biotech/pharma.
• Comprehensive expertise in bioanalysis assays including ELISA, MSD, qPCR/ddPCR, and LCMS/MS Ligand-Binding assay.
• Profound understanding of global GLP guidelines and regulatory directives from FDA, EMA, ICH.
• Demonstrable skills in pharmacokinetics, pharmacodynamics, and biomarker assay methodologies.
• Exceptional presentation capabilities with the skill to inform and engage diverse teams.
• A strong collaborative spirit, adept at synchronizing with coworkers and senior leadership.

Preferred Experience:

• Leadership credentials, underlined by experience in team and project management within regulated labs.
• Aptitude in crafting regulatory documents for NDA/BLA submissions.
• Familiarity with AAV, cell & gene therapies.
• Proven proficiency in managing CROs with a focus on strategic oversight.
• This firm is staunchly committed to equal opportunity, fostering a workplace where diversity is celebrated. They strictly adhere to all non-discrimination laws at federal, state, and local levels.

For those ready to shape the genetic future, they are encouraged to apply for immediate consideration. Those seeking other opportunities in the R&D sector are welcome to reach out directly.