Scientific Affairs Manager

Job Description

Who is USPThe U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USPs fundamental belief that Equity Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.Brief Job OverviewThe (Senior) Scientific Affairs Manager will be responsible for delivering the scientific information to grow USPs 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 PERCENT .How will YOU create impact here at USPRoles and Responsibilities

• Developing and maintaining relationships and collaborations with key scientific thought leaders, scientific societies, and industry associations to facilitate scientific interactions.
• Channeling USPs technical thought leadership and growing USPs influence in the S Asia and APAC regions 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 USPs 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.

Who USP is Looking ForThe 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:

• Masters 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 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.

Manager:

• Masters 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 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 Desired Preferences:Desired preferences are to showcase any additional preferred levels of expertise to perform the role. Reminder: any items listed in this section are not requirements nor disqualifies for candidate consideration.

• 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.
• Ability to develop and deliver compelling technical papers and presentations for scientific and regulatory audiences.
• Able to establish and nurture relationships with individuals of varying backgrounds and learning styles.
• Understanding of the industry trends & needs and ability to translate them into insights for strategic decision making would be an added advantage.
• 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.

Supervisory Responsibilities:This is a non-supervisory position.BenefitsUSP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing is protected.USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our workfrom the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.Locations: Hyderabad, Telangana, India

Keyskills :
scientific communicationanalytical testing knowledgeregulatory compliance expertise relationship building presentation & public speaking learning recruitment communication skillsdecision making