Scientific Affairs Manager

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.
• 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

• Demonstrated understanding of 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.
• Strong understanding of impurity control strategies, including organic, inorganic, elemental impurities, residual solvents, extractables and leachables.
• 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 leachables, sterility testing would be an added advantage.
• Proficiency in English is required.

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.
• 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.
• 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 and engaging external customers and stakeholders in scientific fields.
• Experience working with government and regulatory authorities would be an added advantage.