Scientific Affairs Manager

We need to output HTML fragment with sections only if real content. Use

for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must not repeat job title. No Job ID. Remove boilerplate like EEO, etc. Keep substantive info. We need to parse description. Sections: - About the role: maybe from "Brief Job Overview" and "Who is USP?"? Actually "Brief Job Overview" is about role. Also "Who is USP?" is organization description, maybe not needed as section? Could include under About the role? The instruction: use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can create About the role using the brief job overview and maybe mission description. - Responsibilities: list from "The Scientific Affairs Manager Has The Following Responsibilities" bullet points. - Requirements: maybe from "Who is USP Looking For?" includes competencies and experience; could be Requirements. - Qualifications: maybe education etc. Could separate but we can combine? The instruction: prefer few substantive sections over many thin ones. So we could have About the role, Responsibilities, Requirements (including qualifications and skills). Benefits section if present: there is a Benefits paragraph. Pay and Schedule: not specified (only travel up to 50-60% but not pay). So we should not create Pay or Schedule sections because no specific content. Benefits we have a paragraph: "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." That's substantive enough for Benefits. We must not include boilerplate like Note about unsolicited resumes, Job Category, Job Type maybe could be included? Job Type Full-Time could be considered schedule? But schedule is about hours? Not given. Could include Job Type under About the role? Might be considered metadata; we could drop or include in short p. The instruction: do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

or drop it. Job Type Full-Time is minor metadata; we could fold into a short p under About the role or drop. Probably drop. We must preserve all substantive information; do not invent or summarize away detail. So we need to keep all details from responsibilities, requirements, qualifications, skills, benefits. Let's extract. About the role: from "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 non‑supervisory position based in Tokyo or Osaka, with travel requirements of up to 50-60%." Also maybe include mission description from earlier "Who is USP?" but that's about organization; could be part of About the role? Might be considered organization overview, but we can include as part of About the role to preserve info. However the instruction: "Prefer a few substantive sections over many thin ones." So we could combine organization description into About the role as well. But we must not repeat job title as heading. That's fine. Responsibilities: list bullet points: - 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. - 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. - 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. - Collaborate cross functionally with science, marketing, regulatory, and strategic customer development (SCD) teams to provide scientific input. Requirements/Qualifications/Skills: Let's parse "Who is USP Looking For?" and "Additional Desired Preferences". We have: - 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. - 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. - Biopharmaceutical knowledge is retained but positioned as supporting USP’s portfolio. - Good understanding of impurity testing, extractables and leachable, sterility testing would be an added advantage. - Proficiency in English is required. Korean and other language knowledge is added advantage. - Additional Desired Preferences: - 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. We can combine into Requirements section (maybe split into Qualifications and Skills but we prefer few sections). We'll make a Requirements section that includes education, experience, knowledge, skills. We must not include filler like "commensurate with experience". Not present. Benefits: we have paragraph. We should not include Pay or Schedule sections. Now produce HTML fragment:

About the role

USP is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. USP believes scientific excellence is driven by fairness, integrity, and global collaboration, demonstrated by over 1,300 professionals across twenty global locations working to strengthen the supply of safe, high-quality medicines worldwide. USP values inclusive scientific collaboration, equitable access to mentorship, professional development, and leadership opportunities, and fosters a culture that supports these values. 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 non‑supervisory position based in Tokyo or Osaka, with travel requirements of up to 50‑60%.

Responsibilities

• Provide scientific guidance on the application and adoption of USP–NF monographs, general chapters, and compendial analytical methods, including validation, verification, and system suitability.
• Advise 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.
• 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.
• 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.
• Collaborate cross‑functionally with science, marketing, regulatory, and strategic customer development (SCD) teams to provide scientific input.

Requirements

• 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.
• 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.
• Good understanding of impurity testing, extractables and leachable, sterility testing would be an added advantage.
• Proficiency in English is required; Korean and other language knowledge is an added advantage.
• Strong presentation and communication skills (written and oral).
• Knowledge of the bio‑/pharmaceutical industry and the associated regulatory framework is essential.
• Ability 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 a global environment.
• Experience working with government and regulatory authorities would be an added advantage.

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.

We must ensure no extra sections like Pay or Schedule. Also ensure no markdown fences. Output only HTML. Check for any leftover boilerplate: we removed EEO