Scientist IV III Reference Standards Evaluation
Scientist IV III Reference Standards Evaluation
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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 is a handson nonsupervisory position responsible for the oversight and successful implementation and completion of all activities pertaining to a portfolio of Reference Standards (RS)/Material Strategy program (CRM/ARM etc.. This incumbent is responsible for the timely preparation of procurement specification and collaborative testing protocols for all RS lots technical assistance for collaborating labs analytical data review and preparation of summary reports preparation of packaging and Quality Control testing instructions.
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.
The SIII/SIV position has the following responsibilities:
- Responsible for timely preparation of collaborative testing protocols for new/replacement RS lots technical assistance for collaborating labs
- To review the analytical data received from the Collaborators and to prepare summary reports and RSCEP packages preparation of packaging and QC testing instructions and assigning periodic retest intervals. Independently maintains successful scheduling operations necessary documents complete and accurate information; and addresses quality issues to ensure availability of reference standards in a complex portfolio.
- To Draft product planning documents (PPD) coordinates with labs and reviews/interprets data from international collaborative studies.
- To Coordinates for any additional necessary testing and assists other staff members in addressing the comments.
- To provide correct guidance on the interpretation of test data Proposes and designs studies to obtain necessary data to resolve complaints.
- To support Documentary Standard team by peer review of draft monograph
- To demonstrate technical understanding to internal and external audiences regarding USPs Reference Standards program.
- Engages in conversation about reference standards issues. Addresses general customer technical inquiries and thoroughly investigates customer complaints with minimal guidance.
- Presents information to USP staff and external audiences.
- Facilitates additional crossfunctional activities with other departmental staff and other USP staff.
- Performs other related duties as assigned.
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:
Scientist IV
MSc/MPharm with 810 yrs of experience (or) Ph.D. with 35 yrs of experience
Scientist III:
MSc/MPharm with 68 yrs of experience (or) Ph.D. with 13 yrs of experience
- Ability to read and interpret spectroscopic analyses data (NMR IR MS etc.
- Hands on experience on chromatographic techniques (HPLC GC)
- Ability to handle multiple priorities in a fastpaced environment.
- Excellent written and verbal communications skills.
Additional Desired preferences
- Hands on experience spectroscopic analyses data (NMR IR MS etc. and knowledge on chromatographic techniques.
- XRD Polymorphic studies exposure
- Stability studies exposure
Supervisory Responsibilities: NA
If yes what is the number of direct reports and their titles
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
