Senior Scientist I, Documentary Standards (Pipeline Biologics)

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 hands-on non-supervisory non-laboratory role that serves as the liaison between the biopharmaceutical industry regulatory agencies USP departments and USP Expert Committees. The Documentary Standard Sr. Scientist facilitates the development of USP standards used by the global pharmaceutical this role the incumbent will provide expertise leadership and guidance to USP Expert Committees and Expert Panels in the areas of mAbs 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.

• Identifies opportunities for new standards and solutions to address analytical challenges associated with the next generation of biological strategies and processes for the elaboration of a steady pipeline of standards to support the analytical evaluation of different classes of biotherapeutics.
• Develops relationships with key stakeholders from academia industry and regulatory communities to engage in collaborations in early pipeline development projects. Leads collaborations with academic and stakeholder groups.
• Collaborates with the biologics program unit team to gather insights based on internal and external data and perform analyses to inform on opportunities for further exploration. Communicates and maintains working relationships with other USP departments as applicable.
• Plans and oversees necessary laboratory work for feasibility and proof of concept studies. Evaluates and analyzes scientific reports and identifies next steps and key challenges. Engages and builds relationships with internal and external laboratories to participate in round robin studies or in support of feasibility and proof of concept studies.
• Partners with the standards production team leads for eventual handoff leading to planning and initiation of standards development projects.
• Collaborates with internal groups to develop application notes training materials and online content to support standards.
• Leads expert panels and industry working groups; recruits and engages with members defines project scope and designs and advances work with input from external stakeholders and USP departments.
• Serves as representative of USP at professional scientific meetings organized by USP and other organizations. Gives public presentations on USP matters (as assigned).
• Stays ahead of current trends and developments in related scientific fields particularly in the area of monoclonal antibodies and/or therapeutic proteins.

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. A base of 7-10 years of relevant experience with bioanalytical development in the pharmaceutical industry.
• MS. level candidates with minimum of 11-13 years of commensurate industrial experience.
• Combination of fundamental work experience and education may be substituted
• Experience in process development analytical characterization and chemistry and manufacturing control (CMC) for experience in the areas of characterization and analysis of biopharmaceuticals
• Experience in method development and characterization of biological products impurities and raw materials using a variety of physicochemical techniques and biological assays.
• Experience in method development qualification and/or validation method transfer and development of system suitability criteria.

Additional Desired Preferences

• Knowledge of reference standards related to biopharmaceutical products/industry. Experience with reference materials manufacturing and development is a plus.
• Knowledge of national and international regulatory filings approaches. Familiarity with regulatory guidance documents from WHO FDA ICH and other international organizations.
• Demonstrated research technical and analytical skills as well as the ability to take highly technical scientific information and make recommendations.
• Strong writing skills and experience drafting technical reports related to material characterization method development and reference standard evaluation.
• Expertise in analytical methods applicable to biotherapeutics. Experience in analysis of proteins peptides or oligonucleotides would be a plus. Experience in immunogenicity testing is also a plus.
• Demonstrated stakeholder collaboration experience with the ability to develop and manage internal and external relationships and contacts.
• Ability to establish and nurture relationships with individuals of varying backgrounds and learning styles.
• Excellent presentation and communication skills (written and oral).
• Ability to communicate technical information with non-technical or non-scientific staff and to interact effectively with representatives from pharmaceutical companies government and academic institutions.
• Project Management skills. Must have ability to prioritize and manage multiple concurrent projects with often long-life cycles.
• Effective at operating independently where appropriate yet understands when to escalate issues and how to establish effective working relationships.
• Able to perform in a fast-paced environment with changing deadlines and priorities. Ability to manage and prioritize multiple concurrent projects.
• Experience and knowledge of the USP-NF is preferred.

Supervisory Responsibilities

None this is an individual contributor role.

Benefits

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings you can have peace of mind that your personal and financial well-being 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.

Required Experience:

Senior IC