The U.S. Pharmacopeial Convention (USP) Technical Advisor (Bio Vaccines) - PQM+ in Rockville, Maryland
Who is USP?
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 hardworking professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Brief Job Overview
The Technical Advisor is a subject matter expert in biological product analysis, with primary focus on vaccines; to include method identification and evaluation, instrument selection and management. Responsible for the implementation of PQM+ technical assistance activities related to biological products and biotherapeutics physical chemical and microbiological testing. Reporting to the Senior Technical Advisor Laboratory QMS/QA/QC. The Technical Advisor will liaise and collaborate with headquarter senior technical advisors, regional technical officers, project managers and chiefs of party to ensure the successful implementation of program objectives. Providing technical assistance and mentorship to multiple designated countries within the PQM+ portfolio in areas of laboratory quality assurance and control operations. Additionally, applying knowledge of analytical testing methodologies and measurement science to create and deliver training as well as technical assistance on activities related to compendial testing, instrument/equipment qualification, calibration, and preventative maintenance as well as general quality processes.
How will YOU build impact here at USP?
· Assist national quality control laboratories to align with biological product testing requirements defined in international standards and guidelines; to include ISO/IEC 17025, and WHO Prequalification.
· Evaluate biological testing laboratory quality management and technical operations systems to determine strengths and areas for potential improvement.
· Develop implementation plans which allow laboratories to systematically build their capacity and the sustainability of its operations.
· Supply to the development and implementation of work plan technical activities, processes and systems to aid laboratories in preforming routine and non-routine analytical testing procedures as per manufacturing summary protocols and regulatory requirements, stability protocols, raw material requests for testing; etc.
· Partner with USP and PQM+ technical team members, consultants, other PQM+ countries, vendors, and local stakeholders to assure adequate laboratory facility design and startup.
· Support NMRAs and national quality control labs in the development of lot release testing capacity and in the implementation of vaccine post-marketing surveillance. Also support the GMP inspectorate of the NMRA to strengthen its capacity for regulatory oversight of vaccine manufacturers.
· Liaise with HQ Vaccines Director to develop appropriate training materials and to coordinate the delivery of training.
· Participate in the creation and delivery of onsite and remote trainings on QA/QC topics.
· Mentor and coach laboratory staff to build their capacity in laboratory processes.
· Supply to the development of communication materials and the dissemination of standard methodologies and lessons learned.
· Gain programmatic data and develop progress reports as guided by the PQM+ HQ Vaccines Director. Also, support the development of technical and communication materials related to quality assurance testing of biological products.
Who USP is Looking For?
The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with team members, along with the following competencies and experience:
· BS Chemistry or Analytical Chemistry, or related field, with a minimum of 5-years' experience in operating analytical laboratory equipment.
· At least 4-years' practical experience in biologics testing: Protein Concentration, RNA Content, Purity, Identity, Identity.
· At least 4-years' experience using UV spectrophotometer, multi-mode plate reader, Chromatography systems, RT-PCR system.
· Knowledge and experience with ISO standards for quality systems and laboratory operations; with 1-3 years' experience.
· Working knowledge and understanding of laboratory quality elements, quality control measures, and key aspects of medicines quality testing.
· Excellent written and verbal communication skills and the ability to communicate science/technical information to those without a background in science.
· Familiar with and demonstrates knowledge of GMP/GXP/GLP and the importance of data integrity.
· Knowledge and understanding of analytical concepts, principles, and theories related to chemical and microbiological analyses.
· Familiar with instrumentation used in pharmaceutical, medical device, and microbiology laboratories.
· Ability to troubleshoot and problem solve.
· Ability and desire to influence without direct authority as well as work well with diverse group of employees and customers in a coordinated and friendly manner.
Additional Desired Preferences
Desired preferences are to showcase any additional preferred levels of expertise to perform the role. Reminder: any items listed in this section are not requirements nor disqualifiers for candidate consideration.
· Master of Science or PhD in pharmacy, pharmaceutical science, chemistry, biochemistry, engineering, or science related field of study
· Prior experience in a government funded programs, such as USAID.
· Intermediate digital literacy: office, excel, PowerPoint, SharePoint
· Solid understanding of key public health issues and trends, including in TB, HIV/ AIDS, NTD, MNCH, Malaria and AMR
· Results driven with proven successful outcomes.
· Experience with and understanding of WHO vaccine pre-qualification and/or other regulatory authority registration processes.
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 is protected.
COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired:
As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work --from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
Note: 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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Technical Programs
Job Type Full-Time