Senior Scientist I Documentary Standards
Senior Scientist I Documentary Standards
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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 nonlaboratory role that serves as the liaison between the biopharmaceutical industry regulatory agencies USP departments and USP Expert Committees. The Sr. Scientist facilitates the development of USP standards used by the global pharmaceutical industry. In this role the incumbent will provide expertise leadership and guidance to USP Expert Committees and Expert Panels in the areas of therapeutic proteins peptides oligonucleotides antibiotics gene therapy and vaccines by facilitating the exchange of highly technical information and working collaboratively to improve and promote public health
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 SSI has the following responsibilities:
Roles and Responsibilities
- Works with key stakeholders to develop new and innovative standards for biotechnology pharmaceutical products including therapeutic proteins peptides oligonucleotides antibiotics gene therapy and vaccines.
- Oversees and facilitates the development of standards and solutions to address analytical challenges associated with the next generation of biological medicines.
- Conducts scientific review to the supporting documents for the documentary standard development.
- Plans and oversees necessary laboratory work for method development validation and verification.
- Prepares standard proposals and provides assistance as needed for the USP Expert Committees and Expert Panels to help with the documentary standard development for decision provides requested background information and coordinates laboratory work.
- Performs technical review during documentary standard development
- Communicates and maintains working relationships with other USP departments regarding projects related to documentary standards and other crosscutting activities.
- Responds to stakeholder inquiries pertaining to USPNF documentary standards.
- Serves as representative of USP at professional scientific meetings organized by USP and other organizations. Gives public presentations on USP matters.
- Performs other 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:
- Ph.D. degree in Analytical Chemistry Biochemistry Biology or a relevant field. Minimum of 7 to 10 years of posteducational work experience in bioanalytical development for biotherapeutics in Analytical Chemistry Biochemistry or Biological Sciences with minimum of 11 to 13 years of commensurate industrial experience.
- Experience with pharmaceutical and biotechnology product development and characterization
- Handson experience with bioanalytical technologies such as HPLC LCMS CE ELISA ddPCR and qPCR
- Experience with method development validation verification and specification setting
- Knowledge of compendial standards and USPNF Knowledge of the pharmaceutical industry and the associated regulatory framework is essential.
- Knowledge of national and international regulatory filings approaches. Familiarity with regulatory guidance documents from WHO FDA ICH and other international organizations.
Additional Desired Preferences
- Able to establish and nurture relationships with individuals of varying backgrounds and learning styles.
- Able to operate independently where appropriate yet understands when to escalate issues and how to establish effective working relationships.
- Strong presentation and communication skills (written and oral).
- Welldeveloped organizational interpersonal communications negotiation writing and strong listening skills.
- Project management skills. Must have ability to prioritize and manage multiple concurrent projects with often long life cycles.
Supervisory Responsibilities
No
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 specific
Required Experience:
Senior IC
Employment Type
Full-Time
