U.S. Pharmacopeial Convention Jobs

Job Information

The U.S. Pharmacopeial Convention (USP) (Senior) Scientific Affairs Manager, Asia Pacific in Seoul, South Korea

Description

Summary of the Position

The (Senior) Scientific Affairs Manager – Asia Pacific, will share our vision of better-quality health for everyone and is driven by the opportunity to make an impact. This professional role will be responsible for being USP’s voice of science to grow USP’s scientific presence and thought leadership, and support market growth and utilization of USP standards in region and globally with focus on biopharmaceuticals. The incumbent will work closely with USP’s customer engagement, marketing, scientific, and external affairs staff globally. Travel is anticipated up to 50% to 60%.

Roles and Responsibilities

  • Develops and delivers scientific collateral explaining the science behind USP’s monographs, general chapters, and reference materials to both scientific and non-scientific USP stakeholders and customers including the bio/pharmaceutical industries, regulators, academics, and USP staff

  • Establishes and maintains relationships and collaborations with key scientific thought leaders in bio/pharmaceutical research, manufacturing, regulatory communities to support standards development at USP particularly in the area of next generation therapeutics

  • Channels USP’s technical thought leadership in bio/pharmaceutical quality standards and grows USP’s influence in the Asia Pacific region science community including drafting technical white papers, presenting at technical conferences and formation of advisory boards

  • Collects and disseminates insights on scientific and technical trends in bio/pharmaceutical research, quality control, manufacturing, and regulations in Asia

  • Acts as a resource to regional customer engagement and international government affairs colleagues to assist in achieving goals, including scientific engagement with industry, regulators and key stakeholders

  • Provides scientific affairs support to other geographies and scientific areas within USP’s mission

  • Develops contents for and delivers technical presentations and educational courses on USP quality standards and reference material science for bio/pharmaceuticals

  • Reviews promotional materials and scientific publications developed by colleagues in other departments

Basic Qualifications

Scientific Affairs Manager:

Ph.D. in Biochemistry, Biology, Chemistry, or allied field with a minimum of 5 years; or M.S. and 7 years; or B.S. and 10 years of relevant experience with analytical development and/or quality control for bio/pharmaceuticals that includes at least 5 years in a regulated biopharmaceutical environment. An equivalent combination of experience and education may be substituted

Senior Scientific Affairs Manager:

Ph.D. in Biochemistry, Biology, Chemistry, Pharmacy or allied field with a minimum of 8 years; or M.S. and 10 years of relevant experience with analytical development and/or quality control for bio/pharmaceuticals that includes at least 5 years in a regulated bio/pharmaceutical environment. An equivalent combination of experience and education may be substituted

Preferred Qualifications

  • Biologics / biotherapeutics training and experience including experience in a manufacturing environment preferred

  • Knowledge and experience with regulatory requirements and guidelines for biotherapeutics and pharmaceuticals (e.g. FDA, ICH, etc.)

  • Excellent interpersonal, listening, and communication skills are required

  • 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

  • Self-motivated with ability to collaborate with colleagues in science, marketing and strategic customer development, and across geographies

  • Knowledge and experience with the process and science used to develop new and revise existing USP-NF monographs, general chapters, and reference materials

  • Established scientific network in Asia biotherapeutics community

  • Korean and English language proficiency

  • Ability to travel

Supervisory Responsibilities

None

Job Category Professional Programs

Job Type Full-Time

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