Scientific Affairs Manager ( Biologics)

Brief Job Overview

As part of USP’s mission to advance scientific rigor and strengthen public health globally, this role contributes to expanding access to high-quality medicines through public standards and related programs. The Scientific Affairs Manager plays a critical role in communicating and amplifying USP’s science across the region, strengthening scientific visibility and external engagement with customers, regulatory authorities, and key stakeholders. The position supports the understanding, adoption, and appropriate applications of USP compendial standards including analytical methods, reference standards, and impurity controls across pharmaceutical and selected biopharmaceutical products. This role translates complex scientific and technical content into clear, impactful engagement strategies and insights, while capturing regional scientific and regulatory intelligence to inform organizational priorities and planning. This is a remote Non-Supervisory position residing in one of the following states: New Hampshire, Maryland, DC, Virginia, Pennsylvania, North Carolina, or Florida, requiring up to 60% domestic travel.

How will YOU create impact here at USP?

As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards. Additionally, USP's People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.

Responsibilities

Scientific Engagement & Technical Support:

• Provide scientific guidance on the application and adoption of USP–NF monographs, general chapters, and compendial analytical methods, including validation, verification, and system suitability.
• Advice on the selection, qualification, and lifecycle management of USP Reference Standards in accordance with compendial expectations.
• Provide support and technical input to stakeholders on impurity profiling, control strategies, analytical method development, transfer, troubleshooting, and compendial compliance in alignment with USP standards and ICH guidelines.

Stakeholder Collaboration:

• Build and sustain collaborative relationships with industry, regulators, academia, and scientific associations.
• Deliver scientific presentations, workshops, and customer & regulatory engagements to support awareness and adoption of USP standards.

Insight Generation:

• Monitor evolving scientific and regulatory trends across pharmaceutical R&D, quality control, and manufacturing.
• Gather and communicate regional scientific and regulatory feedback to internal USP scientific and cross-functional teams.

Cross-Functional Support:

• Collaborate cross functionally with science, marketing, regulatory, and strategic customer development (SCD) teams to provide scientific input.

Qualifications

• Master's degree with 6-8 years, or Ph.D. with 4–6 years of experience in Life Sciences, Chemistry, Biochemistry, Pharmaceutical Chemistry, Biotechnology, or a related discipline, including demonstrated experience with USP–NF tests and standards, compendial methods, and regulatory requirements, or equivalent combination of education and experience.
• Minimum of 2 years of experience working in pharmaceutical or biopharmaceutical development, quality, regulatory science, or analytical sciences.
• Knowledge of various analytical testing procedures and methodologies, and regulatory knowledge (FDA, ICH, etc.) for approval of bio-/pharmaceutical products.
• Demonstrated expertise in pharmaceutical analytical sciences, with strong working knowledge of USP–NF compendial standards, analytical methods, and reference standards.
• Strong understanding of impurity control strategies, including organic, inorganic, elemental impurities, residual solvents, extractables and leachable.
• Exposure to USP compendial testing, analytical methods, or reference materials is highly desirable.
• Experience in biopharmaceutical products (mAbs, CGT etc.) will be an important area of focus within the broader scope of this role.
• Good understanding of impurity testing, extractables and leachable, sterility testing would be an added advantage.
• Proficiency in English is required.

Skills & Competencies

• Strong presentation and communication skills (written and oral).
• Knowledge of the bio-/pharmaceutical industry and the associated regulatory framework is essential.
• Must be able to share technical information with non-technical or non-scientific staff, and to communicate effectively with representatives from pharmaceutical companies, government, and academic institutions.
• Experience working and engaging external customers and stakeholders in scientific fields.
• Able to establish and nurture relationships with individuals of varying backgrounds and learning styles.
• Well-developed organizational, interpersonal communications, writing, and strong listening skills.
• Self-motivated with ability to collaborate cross functionally and experience working in global environment.
• Experience working with government and regulatory authorities would be an added advantage.
• Supervisory Responsibilities: None, this is an individual contributor role.

Compensation

Base Salary Range: USD $112,700.00 – $146,900.00 annually. Target Annual Bonus: % Varies based on level of role. Individual compensation packages are based on various factors unique to each candidate's skill set, experience, qualifications, equity, and other job-related reasons.