Senior Scientific & Standards Liaison @ United States

Roles and Responsibilities

• Works with key stakeholders to develop new and innovative standards for biotechnology pharmaceutical products including advanced therapies, genomics and vaccines.

• Oversees and facilitates the development of standards and solutions to address analytical challenges associated with the next generation of biological medicines.

• Develop relationships and partnerships with key stakeholders, within the research, manufacturing and regulatory communities

• Writes general and specific subject correspondence pertaining to documentary standards, reference materials, and various USP policy issues. Evaluates and analyzes scientific reports and supporting validation data and translates specifications and test methods into USP documentary standards.

• Plans and oversees necessary laboratory work for method development and verification, and reference standard evaluations as needed.

• Communicates and maintains working relationships with other USP departments regarding projects related to validation studies, methods development, reference standards, and other cross-cutting activities.

• Keeps abreast of current trends and developments in related scientific fields, particularly in the areas of advanced therapies, genomics and vaccines.

• Responds to stakeholder inquiries pertaining to USP-NF documentary and reference standards

• Serves as representative of USP at professional scientific meetings organized by USP and other organizations. Gives public presentations on USP matters (as assigned).

• Prepares standards proposals and provides assistance, as needed, for the USP Expert Committees and Expert Panels of the Council of Experts e.g, helps with the development of monograph proposals for decision, provides requested background information and coordinates laboratory work, as needed.

• Designs and oversees the execution of collaborative testing once a candidate material has been sourced. Prepares data summary and analysis from collaborative studies.

Basic Qualifications

Ph.D. degree in Biochemistry, Biology, Pharmacy, or a related field and eight (8) years, or Master s degree and ten (10) years of relevant experience in analytical development for biotherapeutics / vaccines / advanced therapies that includes at least 5 years in a regulated biopharmaceutical environment.

Ph.D. degree in Biochemistry, Biology, Pharmacy, or a related field and ten (10) years of relevant experience in analytical development for biotherapeutics/vaccines/ advanced therapies that includes at least 5 years in a regulated biopharmaceutical environment. An equivalent combination of experience and education may be substituted.

Preferred Qualifications

Experience with reference materials development is a plus.

Strong presentation and communication skills (written and oral).

Practical experience in scientific analytical techniques.

Experience and knowledge of the USP-NF is preferred.