Technical Advisor, Chemistry, Manufacturing & Controls (CMC)

Location
Rockville, MD
Posted
May 20, 2022
Ref
TECHN001619
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

Summary of the Position

The Promoting the Quality of Medicines Plus (PQM+) program, funded by USAID and implemented by USP, improves access to quality-assured priority medicines and addresses the proliferation of poor-quality medical products in low- and middle-income countries.  PQM+ works to strengthen medical product quality assurance systems through cross-sectoral and systems strengthening approaches and the application of international quality assurance standards across the pharmaceutical system.  By sharing scientific expertise and providing technical support and leadership, PQM+ helps create resilient and robust local health systems that address diseases like HIV/AIDS, tuberculosis, malaria and neglected tropical diseases, as well as improves maternal, newborn and child health.   

PQM+ is seeking a Technical Advisor, Chemistry, Manufacturing and Controls (CMC) to foster expanded capabilities in medical products manufacturing in low- and middle-income countries. This role is responsible and accountable for providing technical assistance and oversight to manufacturers and regulators to achieve the objectives of increasing the supply of quality-assured essential medical products.  The Technical Advisor, CMC will partner with internal USP departments as well as regulators and manufacturers of medical products to be a trusted expert providing guidance in the area of medical products manufacturing.

Roles and Responsibilities

• Lead in the provision of PQM+ technical assistance and oversight to manufacturers and regulators to achieve the objectives of increasing the supply of quality-assured essential medical products.

• Provide technical assistance to manufacturers in GLP, GMP, technology transfer, and dossier development and submission through audits, trainings, and deployment of tools and approaches to ensure adoption of international quality standards. 

• Provides oversight for local CMC staff, local partners and consultants involved in delivery of manufacturing support

• Identify CMC risks and support the development of mitigations and contingency plans.

• Conduct audits to assess compliance with international standards from WHO Prequalification process and support manufacturers to develop strategies and tools to address deviations and non-compliance identified. 

• Work closely with teams to support development and deployment of strategies

• Supports the work and efforts of the Senior Technical Advisor, Product Supply Management and CMC to develop technical documents on manufacturing and other medical products 

• Keep abreast of the latest analytical technology in industry and regulation requirements

• Be the technical point of contact at global level and recognized leader actively advancing and deploying new technologies and trends in manufacturing

• Represents USP and PQM+ Program in local and regional forums on manufacturing

• Actively contribute to annual programmatic and resource planning process and contribute to programmatic growth.

Basic Qualifications

• BS degree in pharmacy, pharmaceutical science, chemistry, engineering or science related field of study required

• Five (5) of demonstrated experience in medical products manufacturing 

Skills sought

• MS or Ph.D. degree in pharmacy, pharmaceutical science, chemistry, engineering or science related field of study required

• Subject matter expert in manufacturing processes, comparability/feasibility studies, stability studies, analytical development, and regulatory filings

• Thorough understanding of Chemistry, Manufacturing and Controls and Good Manufacturing Practices for medicines, packaging and other relevant areas

• Knowledge of regulatory requirements related to the development and manufacture of medicines in all phases of clinical development

• Direct experience with regulatory authority registration processes 

• Strong written (especially technical writing) and oral communication skills 

• Willingness to travel up to 25% of the time

Preferred Qualifications

• Direct experience implementing USAID-funded programs 

• Experience in at least one of the following health areas: HIV/ AIDS, malaria, TB, NTDs, AMR, MNCH

• Experience with including water systems, sterility, HVAC, contamination, analytical chemistry, cleaning procedures, validation, formulations and other relevant areas

• Direct experience with and understanding of WHO pre-qualification and/or other regulatory authority registration processes

Supervisory Responsibilities

N/A

COVID Provisions 

 As a condition of employment with United States Pharmacopeial Convention’s (USP) duty to provide and maintain a workplace that is free of known hazards,  all employees and contingent staff hired after July 1st, 2021 are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will  advise accordingly.

Benefits

USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.

About USP

The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.