BioSpace
Senior Technical Advisor, Pharmaceutical Formulation and Manufacturing Strategy
BioSpace, Rockville, Maryland, us, 20849
Senior Technical Advisor, Pharmaceutical Formulation and Manufacturing Strategy
About USP
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. USP is committed to scientific excellence, fairness, integrity, and global collaboration. The organization is driven by a core value of Passion for Quality, with more than 1,300 professionals across twenty global locations working to strengthen the supply of safe, high‑quality medicines worldwide.
Job Overview
USP seeks a Senior Technical Advisor to strengthen formulation development expertise and expand capabilities in medical product manufacturing, particularly in low and middle‑income countries. The incumbent will provide technical assistance and oversight to manufacturers, interface with internal departments and external partners, and help increase the supply of quality‑assured essential medical products.
Role Responsibilities
Lead technical assistance in advanced formulation development for complex products, including complex generics and complementary supplements.
Drive innovation in formulation strategies, technology transfer, and dossier preparation to ensure compliance with international quality standards.
Serve as the primary subject‑matter expert, guiding manufacturers through feasibility studies, stability programs, and formulation optimization for commercialization.
Support the USP CMC team in developing technical documents and tools for localizing manufacturing of medical products in LMICs.
Identify CMC risks and support development of mitigations and contingency plans.
Conduct audits assessing compliance with international standards such as WHO Pre‑qualification, and advise manufacturers on improving deviation and non‑compliance issues.
Actively contribute to engagement of private‑sector stakeholders to facilitate public‑private collaboration supporting regional manufacturing of quality pharmaceuticals.
Work closely with teams to support development and deployment of strategies.
Review and provide timely inputs into key project deliverables, including technical and donor reports.
Stay abreast of the latest manufacturing trends and regulatory requirements, especially in Africa.
Represent USP in international forums on manufacturing, as directed by leadership.
Qualifications
BS, MS, or Ph.D. in pharmaceutical science, chemistry, engineering, or a related field.
Minimum 10 years of experience in pharmaceutical manufacturing.
Proven subject‑matter expertise in formulation science, including complex generic formulations, advanced drug delivery systems, comparability/feasibility studies, stability programs, and integration with analytical development and regulatory filings.
In‑depth understanding of CMC and Good Manufacturing Practices for medicines and packaging.
Knowledge of regulatory requirements related to development and manufacture of medicines across all phases of clinical development.
Direct experience with regulatory authority registration processes, including the US FDA.
Strong written and oral communication skills, especially technical writing.
Willingness to travel up to 25% of the time.
Additional Desired Preferences
Experience developing innovative formulations for challenging APIs (e.g., low solubility, high potency).
Expertise in scale‑up and technology transfer of formulations from R&D to commercial manufacturing.
Experience in at least one of the following health areas: HIV/AIDS, malaria, MNCH.
Experience with water systems, sterility, HVAC, contamination, analytical chemistry, cleaning procedures, validation, and formulation related processes.
Understanding of global dynamics impacting the supply of quality‑assured pharmaceuticals and medical products.
Direct experience with and understanding of WHO pre‑qualification and other regulatory authority registration processes.
Supervisory Responsibilities
None—this is a non‑supervisory, individual‑contributor role.
Benefits
USP provides benefits to protect you and your family, including company‑paid time off, comprehensive healthcare options, and retirement savings opportunities.
Compensation
Base Salary Range: USD $123,400.00 – $156,550.00 annually. Target Annual Bonus: Varies based on level of role.
Equal Opportunity Employer
USP is an equal opportunity employer (EEOE) committed to fair, merit‑based selection processes. USP upholds policies that create an inclusive work environment and provides reasonable accommodations to individuals with disabilities. USP is an Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
Job Details
Job Category: Technical Programs Job Type: Full‑Time
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The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. USP is committed to scientific excellence, fairness, integrity, and global collaboration. The organization is driven by a core value of Passion for Quality, with more than 1,300 professionals across twenty global locations working to strengthen the supply of safe, high‑quality medicines worldwide.
Job Overview
USP seeks a Senior Technical Advisor to strengthen formulation development expertise and expand capabilities in medical product manufacturing, particularly in low and middle‑income countries. The incumbent will provide technical assistance and oversight to manufacturers, interface with internal departments and external partners, and help increase the supply of quality‑assured essential medical products.
Role Responsibilities
Lead technical assistance in advanced formulation development for complex products, including complex generics and complementary supplements.
Drive innovation in formulation strategies, technology transfer, and dossier preparation to ensure compliance with international quality standards.
Serve as the primary subject‑matter expert, guiding manufacturers through feasibility studies, stability programs, and formulation optimization for commercialization.
Support the USP CMC team in developing technical documents and tools for localizing manufacturing of medical products in LMICs.
Identify CMC risks and support development of mitigations and contingency plans.
Conduct audits assessing compliance with international standards such as WHO Pre‑qualification, and advise manufacturers on improving deviation and non‑compliance issues.
Actively contribute to engagement of private‑sector stakeholders to facilitate public‑private collaboration supporting regional manufacturing of quality pharmaceuticals.
Work closely with teams to support development and deployment of strategies.
Review and provide timely inputs into key project deliverables, including technical and donor reports.
Stay abreast of the latest manufacturing trends and regulatory requirements, especially in Africa.
Represent USP in international forums on manufacturing, as directed by leadership.
Qualifications
BS, MS, or Ph.D. in pharmaceutical science, chemistry, engineering, or a related field.
Minimum 10 years of experience in pharmaceutical manufacturing.
Proven subject‑matter expertise in formulation science, including complex generic formulations, advanced drug delivery systems, comparability/feasibility studies, stability programs, and integration with analytical development and regulatory filings.
In‑depth understanding of CMC and Good Manufacturing Practices for medicines and packaging.
Knowledge of regulatory requirements related to development and manufacture of medicines across all phases of clinical development.
Direct experience with regulatory authority registration processes, including the US FDA.
Strong written and oral communication skills, especially technical writing.
Willingness to travel up to 25% of the time.
Additional Desired Preferences
Experience developing innovative formulations for challenging APIs (e.g., low solubility, high potency).
Expertise in scale‑up and technology transfer of formulations from R&D to commercial manufacturing.
Experience in at least one of the following health areas: HIV/AIDS, malaria, MNCH.
Experience with water systems, sterility, HVAC, contamination, analytical chemistry, cleaning procedures, validation, and formulation related processes.
Understanding of global dynamics impacting the supply of quality‑assured pharmaceuticals and medical products.
Direct experience with and understanding of WHO pre‑qualification and other regulatory authority registration processes.
Supervisory Responsibilities
None—this is a non‑supervisory, individual‑contributor role.
Benefits
USP provides benefits to protect you and your family, including company‑paid time off, comprehensive healthcare options, and retirement savings opportunities.
Compensation
Base Salary Range: USD $123,400.00 – $156,550.00 annually. Target Annual Bonus: Varies based on level of role.
Equal Opportunity Employer
USP is an equal opportunity employer (EEOE) committed to fair, merit‑based selection processes. USP upholds policies that create an inclusive work environment and provides reasonable accommodations to individuals with disabilities. USP is an Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
Job Details
Job Category: Technical Programs Job Type: Full‑Time
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