Scientist III, RSL
Scientist III, RSL
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Job Description
Who is USP
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds top authorities in health and science to develop quality standards for medicines dietary supplements and food ingredients. USPs fundamental belief that Equity Excellence manifests in our core value of Passion for Quality through our more than 1300 hardworking professionals across twenty global locations to deliver the mission to strengthen the supply of safe quality medicines and supplements worldwide.
At USP we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create the partnerships we build and the conversations we foster we affirm the value of Diversity Equity Inclusion and Belonging in building a world where everyone can be confident of quality in health and healthcare.
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 workan environment where every employee feels fully empowered and valued irrespective of but not limited to 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.
Brief Job Overview
This nonsupervisory role in the Reference Standard Laboratory involves performing necessary project tests and maintaining a GLPcompliant environment. The incumbent leverages their technical expertise and pharmaceutical analysis knowledge to conduct collaborative testing and ensure efficient and effective laboratory operations.
How will YOU create impact here at USP
In this role at USP you contribute to USPs public health mission of increasing equitable access to highquality safe medicine and improving global health through public standards and related programs. In addition as part of our commitment to our employees Global People and Culture in partnership with the Equity Office regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.
- Executes all collaborative testing and data analysis with precision and accuracy with minimal errors.
- Supports Verification GPH PQM stability and other departmental teams for testing and project reviews as needed.
- Prepares evaluation reports for projects.
- Works with the supervisor to ensure timely completion of assigned projects.
- Reviews project reports and documents initially assisting the group leader when necessary.
- Completes projects within the set timelines and troubleshoots scientific issues as they arise.
- Prepares and reviews standard operating procedures (SOPs) protocols and reports.
- Performs scheduled calibration of equipment.
- Prepares executes and completes Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) of new instruments.
- Ensures the availability of necessary chemicals and columns for projects and handles purchase requisitions.
- Takes on additional tasks assigned by the supervisor.
- Maintains lab safety and Good Laboratory Practice (GLP) standards and participates in internal and external audits and certifications.
- Mentors and trains junior team members in daytoday analysis.
Who is USP 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:
The ideal candidate possesses strong analytical chemistry knowledge and can effectively review analyze interpret and report data from various analytical instrumental tests including HPLC GC IC LCMS wet analytical techniques spectroscopic techniques and thermal analysis. Should have welldeveloped organizational and interpersonal skills and can establish and nurture relationships with individuals from diverse backgrounds cultures and learning styles.
- Ph.D. in Chemistry or Masters degree in chemistry / Pharmacy.
Experience:
- 1 to 3 years with relevant laboratory experience for Ph.D. candidates.
- 6 to 8 years with relevant laboratory experience for Masters degree candidates.
- Proven track record of consistently delivering projects on time and with high quality for APIs or Finished Formulations.
- Expert in chromatographic analysis particularly in HPLC and GC.
- Proficient in other related analytical instrumentation such as Titration IR KF UV Thermal analysis Elemental analysis etc.
- Must possess effective communication skills both written and verbal.
- Expert in Empower software with knowledge on Audit trails and Custom fields.
- Must possess good technical and analytical skills to independently resolve or troubleshoot issues.
Should have a strong understanding of GLP regulations and exposure to external regulatory audits.
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 disqualifies for candidate consideration.
- Knowledge of Lab Management Systems Electronic Laboratory Notebooks ERP and QR coding systems is advantageous.
- Handson experience with instruments such as ICPOES/MS IC LCMS and GCMS is beneficial.
- Experience in Analytical Method development and Validation is a plus.
- Experience in pharmaceutical stability studies and maintaining stability chambers is advantageous.
- Understanding monograph procedures and participating in compendial methods for reference materials (USP FCC NF etc.) is important.
- Prior experience in a highvolume pharmaceutical manufacturing QC laboratory Analytical R&D or a contract pharmaceutical analytical laboratory testing organization is beneficial.
- Awareness of ISO/IEC 17025 is desirable.
Supervisory Responsibilities
No
Benefits
USP provides the benefits to protect yourself and your family today and tomorrow. From companypaid time off and comprehensive healthcare options to retirement savings you can have peace of mind that your personal and financial wellbeing is protected.
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 specificwritten agreement with USP.
Employment Type
Full-Time
