The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 hardworking professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Post : Senior Scientific Affairs Manager
Job Overview
The (Senior) Scientific Affairs Manager will be responsible for delivering the scientific information to grow USP’s scientific presence and thought leadership. The incumbent will be required to support scientific engagement, market growth and utilization of USP standards in region and globally. The position is non-supervisory based in Hyderabad, India with the travel requirements in S Asia and APAC up to 50%.
Roles and Responsibilities
• Developing and maintaining relationships and collaborations with key scientific thought leaders, scientific societies, and industry associations to facilitate scientific interactions.
• Channeling USP’s technical thought leadership and growing USP’s influence in the S Asia and APAC region’s scientific community including drafting technical white papers/peer reviewed publications, presenting at technical conferences and formation of advisory boards.
• Keeps abreast of new and changing industry technical and regulatory requirements in pharmaceutical research, quality control and manufacturing. Disseminate the key findings to internal stakeholders for strategic decision making.
• Acting as a resource to regional scientific, sales and marketing teams to support market growth and adoption of USP standards.
• Extend the scientific affairs support to other geographies and scientific areas within USP’s mission as and when required.
• Developing contents/scientific collaterals for and delivering technical presentations and educational courses on USP quality standards and reference materials.
• Reviewing promotional materials and scientific publications developed by colleagues in other departments.
Candidate Profile
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:
Senior Manager :
• Master’s degree with 12-15 years or Ph.D. degree in life sciences, Chemistry/biochemistry, pharmaceutical chemistry, biotechnology or a related field with minimum of 10-12 years, or of relevant experience with USP-NF test and standards.
• Minimum of 6-8 years of experience working in the pharmaceutical and/or biopharmaceutical Industry.
• Knowledge of various analytical testing procedures and methodologies, and regulatory knowledge (FDA, ICH, etc.) for approval of bio-/pharmaceutical products.
• A good understanding and knowledge on the development of Injectables and other complex formulations and/or parenteral biologic formulations (solutions, lyophilized products, and other dosage forms) would be an added advantage.
• Good understanding of impurity testing, extractables and leachable, sterility testing, microbiology would be preferred.
• Knowledge of various analytical testing procedures and methodologies, and regulatory knowledge (FDA, ICH, etc.) for approval of bio-/pharmaceutical products.
Manager :
• Master’s degree with 10-12 years or Ph.D. degree in life sciences, Chemistry / biochemistry, pharmaceutical chemistry, biotechnology or a related field with minimum of 8-10 years, or of relevant experience with USP-NF test and standards required.
• Minimum of 4-6 years of experience with small molecules testing, drug substances and drug products working in the pharmaceutical industry and/or experience with biopharmaceutical characterization, assay development, quality control and stability testing.
• Knowledge of various analytical testing procedures and methodologies, and regulatory knowledge (FDA, ICH, etc.) for approval of bio-/pharmaceutical products.
• A good understanding and knowledge on the development of Injectables and other complex formulations and/or parenteral biologic formulations (solutions, lyophilized products, and other dosage forms) would be an added advantage.
• Good understanding of impurity testing, extractables and leachable, sterility testing would be an added advantage.
• Knowledge of various analytical testing procedures and methodologies, and regulatory knowledge (FDA, ICH, etc.) for approval of bio-/pharmaceutical products.
• Proficiency in English is required.
Additional Information
Experience : 4-6 years
Qualification : MSc. in Chemistry or Ph.D. degree
Location : Hyderabad
Industry Type : Pharma / Healthcare / Clinical research
End Date : 15th November, 2023
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