Senior Technical Manager, API & Advanced Manufacturing

BioSpace; Rockville (MD); On-site; USD 126,000 - 177,000; Full time

Job summary

The U.S. Pharmacopeial Convention (USP) seeks a Senior Technical Manager to lead donor- and program-funded initiatives across supply chain technical assessment and lab-based advanced manufacturing. You will drive route scouting, process development, scale-up, technology transfer, and high-quality deliverables in a collaborative environment.

Ideal candidates hold a Ph.D. in Organic Chemistry (5+ years in industry) or an M.Sc.

Qualifications

• Ph.D. in Organic Chemistry with minimum 5 years of industrial experience in API or fine chemical industries; or M.Sc. in Organic Chemistry with minimum 10 years of industrial experience in API or fine chemical industries.
• Demonstrated independence, broad workstream ownership, and strong matrix leadership across execution-focused technical programs.
• Hands-on experience in laboratory-based process development, route assessment, optimization, scale-up, characterization, or troubleshooting for APIs, fine chemicals, NCEs, or related target molecules.
• Strong foundation in synthetic organic chemistry, modern analytical techniques, reaction monitoring, process optimization, and practical route selection for API or fine chemical development.
• Demonstrated ability to conduct independent literature reviews, design or assess synthetic routes, evaluate reagents and raw materials, and develop technically feasible experimental or implementation plans.
• Demonstrated ability to synthesize scientific, manufacturing, quality, regulatory, and supply chain information into practical recommendations and implementation plans.

Responsibilities

• Lead technical implementation workstreams for supply chain technical assessment and lab-based advanced manufacturing projects.
• Plan and coordinate laboratory-based activities, including route assessment, process development, scale-up, troubleshooting, purification, characterization, and technology evaluation.
• Apply process chemistry, API development, CMC, and advanced manufacturing expertise to practical project challenges.
• Develop and review technical plans, protocols, reports, briefing materials, and project documentation to support high-quality execution and decision-making.
• Conduct structured technical, market, literature, and database reviews to assess API and KSM manufacturing routes, suppliers, technologies, cost drivers, and supply vulnerabilities.
• Evaluate manufacturing processes, sourcing structures, technical feasibility, supply-market dynamics, and risk factors to identify practical mitigation options.
• Translate complex scientific, manufacturing, and supply chain information into clear recommendations, implementation approaches, and decision-support materials.
• Serve as the technical implementation lead for defined project workstreams, with responsibility for coordinating scope, timelines, quality expectations, and deliverables.
• Lead matrixed technical contributors, including internal subject matter experts, external collaborators, and project management partners.

Skills

Matrix leadership

Lab-based process development

Technical reporting

Education

Ph.D. in Organic Chemistry

M.Sc. in Organic Chemistry

Tools

CMC

GMP manufacturing

Tech transfer

Job description

The U.S. Pharmacopeial Convention (USP) seeks a Senior Technical Manager to lead donor- and program-funded initiatives across supply chain technical assessment and lab-based advanced manufacturing. You will drive route scouting, process development, scale-up, technology transfer, and high-quality deliverables in a collaborative environment.

Ideal candidates hold a Ph.D. in Organic Chemistry (5+ years in industry) or an M.Sc.