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Overview
Be among the first 25 applicants. This is a direct supervisory position in the Verification team of USP's Global Laboratory and Technical Operations division. The incumbent is primarily responsible for providing technical and operational management for the verification programs. Who is USP?
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. USP values scientific excellence, fairness, integrity, and global collaboration, and is committed to inclusive scientific collaboration and mentorship, professional development, and leadership opportunities. USP is an equal employment opportunity employer (EEOE) and provides reasonable accommodations to individuals with disabilities, upholding policies that create an inclusive and collaborative work environment. Responsibilities
Provide technical and operational management for the verification programs. Manage and conduct activities related to current Good Manufacturing Practice (cGMP) site audits, quality control and manufacturing (QCM) product documentation reviews, and test design. Develop and implement new tools, procedures, and techniques for the verification team to meet USP objectives and support growth. Lead the verification operational team; provide technical expertise and guidance to team members. Uphold the program’s integrity and impartiality; mentor staff and hold employees accountable for results. Collaborate with other departments (e.g., laboratories, business team) to ensure timely delivery of results and issue resolution. Engage with manufacturers to ensure corrective actions are implemented; provide status reports to guarantee timely service delivery. Monitor industry landscape and act as the technical expert for outreach, including delivering presentations, authoring white papers and articles. Lead continuous improvement efforts and monitor trends to improve daily operations. Perform other duties as assigned. Who USP is Looking For / Qualifications
Bachelor’s degree in chemistry or a related scientific field and 15 years of relevant experience or Master’s degree in chemistry or a related scientific field and 12 years of relevant experience or Ph.D. in science and 10 years of relevant experience. Experience:
Minimum of eight (8) years of relevant experience working in current Good Manufacturing Practice (cGMP) facilities engaged in the manufacture and/or quality control of dietary supplements and/or pharmaceuticals. Knowledge of GMP audits using 21 CFR parts 111 and 117 is required. Working knowledge of compendial standards, analytical methodologies, analytical method development and validation. Additional Desired Preferences:
Minimum of 4 years of people management experience. Extensive knowledge of FDA regulations pertaining to cGMP requirements and proficiency with regulation and guideline interpretation, audit procedures, proper documentation, and quality assurance. Experience with ISO accreditation including ISO 17020 and ISO 17065. Industry experience in the manufacture of dietary supplements and/or pharmaceuticals with various dosage forms. Experience conducting and/or hosting cGMP audits. Certifications such as ASQ CQA or RAPS RAC are a plus. Knowledge of ICH guidelines and CTD/CMC submission experience is preferred. Detail oriented with strong organizational and planning skills. Excellent technical writing and oral communication skills; ability to communicate effectively with diplomacy and enthusiasm. Ability to deal with multiple changing priorities and work with minimal supervision. Supervisory Responsibilities:
Yes. This position will have at minimum five direct and two functional reports consisting of varying levels of scientists and GMP auditors. Benefits and Compensation
Benefits:
USP provides comprehensive benefits to protect yourself and your family, including company-paid time off, healthcare options, and retirement savings. Compensation:
Base Salary Range: USD $131,500.00 – $170,500.00 annually. Target Annual Bonus: varies based on level of role. Individual compensation packages are based on factors such as experience, qualifications, equity, and other job-related reasons. Other:
USP does not accept unsolicited resumes from third-party recruitment agencies except under specific written agreement. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. For more information, review the Know Your Rights poster from the Department of Labor. Job Category:
Technical Programs •
Job Type:
Full-Time
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Be among the first 25 applicants. This is a direct supervisory position in the Verification team of USP's Global Laboratory and Technical Operations division. The incumbent is primarily responsible for providing technical and operational management for the verification programs. Who is USP?
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. USP values scientific excellence, fairness, integrity, and global collaboration, and is committed to inclusive scientific collaboration and mentorship, professional development, and leadership opportunities. USP is an equal employment opportunity employer (EEOE) and provides reasonable accommodations to individuals with disabilities, upholding policies that create an inclusive and collaborative work environment. Responsibilities
Provide technical and operational management for the verification programs. Manage and conduct activities related to current Good Manufacturing Practice (cGMP) site audits, quality control and manufacturing (QCM) product documentation reviews, and test design. Develop and implement new tools, procedures, and techniques for the verification team to meet USP objectives and support growth. Lead the verification operational team; provide technical expertise and guidance to team members. Uphold the program’s integrity and impartiality; mentor staff and hold employees accountable for results. Collaborate with other departments (e.g., laboratories, business team) to ensure timely delivery of results and issue resolution. Engage with manufacturers to ensure corrective actions are implemented; provide status reports to guarantee timely service delivery. Monitor industry landscape and act as the technical expert for outreach, including delivering presentations, authoring white papers and articles. Lead continuous improvement efforts and monitor trends to improve daily operations. Perform other duties as assigned. Who USP is Looking For / Qualifications
Bachelor’s degree in chemistry or a related scientific field and 15 years of relevant experience or Master’s degree in chemistry or a related scientific field and 12 years of relevant experience or Ph.D. in science and 10 years of relevant experience. Experience:
Minimum of eight (8) years of relevant experience working in current Good Manufacturing Practice (cGMP) facilities engaged in the manufacture and/or quality control of dietary supplements and/or pharmaceuticals. Knowledge of GMP audits using 21 CFR parts 111 and 117 is required. Working knowledge of compendial standards, analytical methodologies, analytical method development and validation. Additional Desired Preferences:
Minimum of 4 years of people management experience. Extensive knowledge of FDA regulations pertaining to cGMP requirements and proficiency with regulation and guideline interpretation, audit procedures, proper documentation, and quality assurance. Experience with ISO accreditation including ISO 17020 and ISO 17065. Industry experience in the manufacture of dietary supplements and/or pharmaceuticals with various dosage forms. Experience conducting and/or hosting cGMP audits. Certifications such as ASQ CQA or RAPS RAC are a plus. Knowledge of ICH guidelines and CTD/CMC submission experience is preferred. Detail oriented with strong organizational and planning skills. Excellent technical writing and oral communication skills; ability to communicate effectively with diplomacy and enthusiasm. Ability to deal with multiple changing priorities and work with minimal supervision. Supervisory Responsibilities:
Yes. This position will have at minimum five direct and two functional reports consisting of varying levels of scientists and GMP auditors. Benefits and Compensation
Benefits:
USP provides comprehensive benefits to protect yourself and your family, including company-paid time off, healthcare options, and retirement savings. Compensation:
Base Salary Range: USD $131,500.00 – $170,500.00 annually. Target Annual Bonus: varies based on level of role. Individual compensation packages are based on factors such as experience, qualifications, equity, and other job-related reasons. Other:
USP does not accept unsolicited resumes from third-party recruitment agencies except under specific written agreement. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. For more information, review the Know Your Rights poster from the Department of Labor. Job Category:
Technical Programs •
Job Type:
Full-Time
#J-18808-Ljbffr