MPF Federal, LLC
201 - 500 employees
Founded 2012
🏥 Healthcare
📦 Logistics
🏭 Manufacturing
Healthcare • Logistics • Manufacturing
MPF Federal, LLC is a team of highly experienced professionals dedicated to providing a full range of services for business requirements, including training, technical services, clinical research, life sciences support, and business management. Headquartered in Washington, DC, MPF works with both federal government and commercial clients, offering innovative solutions in information technology, program management, records management, and compliance. Established in 2012 as a SBA Certified HUB Zone and Woman Owned Small Disadvantaged Business, MPF's mission is to meet client needs with measurable performance standards and high-quality deliverables.
CMC Regulatory Consultant – Oligonucleotide Therapeutics
🔥 1 hour ago
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MPF Federal, LLC
201 - 500 employees
Founded 2012
🏥 Healthcare
📦 Logistics
🏭 Manufacturing
Healthcare • Logistics • Manufacturing
MPF Federal, LLC is a team of highly experienced professionals dedicated to providing a full range of services for business requirements, including training, technical services, clinical research, life sciences support, and business management. Headquartered in Washington, DC, MPF works with both federal government and commercial clients, offering innovative solutions in information technology, program management, records management, and compliance. Established in 2012 as a SBA Certified HUB Zone and Woman Owned Small Disadvantaged Business, MPF's mission is to meet client needs with measurable performance standards and high-quality deliverables.
📋 Description
• Provide strategic CMC regulatory guidance throughout product development. • Review and advise on drug substance, drug product, manufacturing, analytical methods, and control strategies. • Lead or contribute to IND CMC sections, FDA briefing packages, and regulatory responses. • Identify regulatory risks and recommend practical mitigation strategies. • Collaborate with cross-functional teams and CDMO partners to support successful development and regulatory milestones.
🎯 Requirements
• Advanced scientific degree (PhD, PharmD, MS, or equivalent). • 10+ years of CMC regulatory experience within pharmaceutical or biotechnology organizations. • Deep expertise supporting **oligonucleotide therapeutics** (antisense oligonucleotides, siRNA, RNA therapeutics, or related technologies). • Extensive experience authoring or reviewing **IND CMC submissions**. • Strong knowledge of FDA CMC regulations and regulatory strategy. • Experience working with CDMOs and multidisciplinary development teams. • **Preferred:** • Experience with targeted intracellular or endosomal drug delivery technologies. • Prior FDA regulatory experience or senior CMC leadership. • Background supporting successful IND submissions.
🏖️ Benefits
• This position does not qualify for benefits.
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