Who is 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's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Brief Job Overview
This is an on-site hands-on technical position at USPs Advanced Manufacturing Technology Lab in Richmond, VA. In this non-supervisory role, the incumbent will plan and carry out activities related to developing analytical methods and perform analyses to support process chemistry development, including continuous operations for active pharmaceutical ingredients (APIs). The incumbent may execute up to 80% of their work at the bench level conducting lab work as part of complex projects, while providing insights, recommendations, and data-based conclusions. They will closely interact with other scientists and/or other USP personnel as well as with external collaborators.
How will YOU create impact here at USP?
Work with a group of innovative scientists to support USPs work in the Pharmaceutical continuous process development and advanced manufacturing technology areas.
Develop and validate analytical methods in collaboration with external science partners for assessing the quality of batch and continuous manufacturing processes and provide analytical support for route development efforts.
Interact closely with external partners of our manufacturing network in identifying, implementing, and troubleshooting test methods and workflows for ensuring compliant, robust pharmaceutical continuous processes.
80% of work is expected to be project work at the bench level using a range of analytical instrumentation primarily LC-MS, GC-MS, HPLC, and GC-FID, including but not limited to:
o Plan, perform, and document analytical analyses and other lab bench work according to SOPs and/or test plans. Demonstrates solid scientific approach in the laboratory.
o Works with team members to develop effective testing plans and experimental designs.
o Process and interpret collected data and report results to collaborators.
o Write final reports and prepare slides for presentations.
o Carry out peer-reviews of analytical data and reports.
o Share technical expertise with other lab staff and cross-train on methods.
o Seek out innovative ways to apply knowledge or skills to improve protocols and results.
o Assist in technology transfer activities.
20% of work is expected to be related to project administration tasks, laboratory operations, or technical development activities, including but not limited to:
o Engage actively in project and team meetings and ensure own work to be aligned with overarching goals.
o Use existing databases to document project progresses, track, and report status of assignments to management on a regular basis.
o Set up, troubleshoot, and maintain instrumentation and equipment within area of expertise and assists others. Proposes equipment to improve lab capabilities as appropriate.
o Share in lab safety and housekeeping responsibilities, including procurement of supplies needed for lab work.
o Follow existing quality system procedures, review and revise SOPs as needed, and recommend process improvements as appropriate.
o Assist lab head in planning, implementing, and evaluating laboratory procedures/systems.
o Work with cross-functional teams within the organization to solve both technical and process-related issues.
o Attends scientific seminars, technical training, and conferences.
o Propose independent research activities to align with USP goals or personal development.
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 stakeholders, along with the following competencies and experience:
Bachelors degree in chemistry or related field with minimum of 7 years of relevant lab experience; or Masters degree in chemistry or related field with 5 years of relevant lab experience; or Ph.D. in chemistry or a related field.
11 years of relevant work experience will be considered in lieu of a degree.
Minimum of four (4) years of experience in project work using analytical chemistry instrumentation which must include mass spectrometry data collection and analysis.
Prior experience in analytical method development or analytical method validation.
Demonstrated interpersonal skills and ability to function in a team-oriented environment.
Good technical writing and verbal communication skills.
Additional Desired Preferences
Pharmaceutical laboratory, pharmaceutical manufacturing, and/or continuous manufacturing experience.
Working knowledge of API drug substance testing and/or finished drug product testing.
Experience in analytical methods development, methods validation, characterization of compounds, and/or instrument validation.
Experience using multiple brands/types of mass spectrometry equipment (LCMS and GCMS).
Hands-on experience with a wide range of analytical instrumentation including, but not limited to HPLC, GC, mass spectrometry, KF titrations, vibrational spectroscopy.
Hands-on experience with troubleshooting, and routine maintenance of chromatograph systems, mass spectrometers, and other laboratory instrumentation.
Experience with gas chromatography instrumentation and analyses.
Experience with a wide variety of software and information systems.
Ability to produce high quality results within deadlines with minimal supervision.
Focus on working in safe and clean environment.
Strong organizational skills and attention to detail.
Skill to anticipate, troubleshoot and solve technical problems.
Capacity to collaborate in a cross-functional group and with diverse teams.
Strong communication and presentation skills, both verbal and written.
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 workfrom 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 contractors legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Technical Programs
Job Type Full-Time