Sr Scientific Affairs Mgr - Hyderabad
- United States
- 8 - 13 years
- Hyderabad
- 3 years ago
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Job Description
Job description
Roles and Responsibilities
- Developing and delivering scientific collateral explaining the science behind USP s monographs, general chapters, and reference materials to both scientific and nonscientific USP stakeholders and customers including the bio/pharmaceutical industries, regulators, academics, and USP staff
- Establishing and maintaining 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
- Channeling USP s technical thought leadership in bio/pharmaceutical quality standards and growing USP s influence in the Asia Pacific region science community including drafting technical white papers, presenting at technical conferences and formation of advisory boards
- Collecting and disseminating insights on scientific and technical trends in bio/pharmaceutical research, quality control, manufacturing, and regulations in Asia
- Acting as a resource to regional customer engagement and international government affairs colleagues to assist in achieving goals
- Providing scientific affairs support to other geographies and scientific areas within USP s mission
- Developing contents for and delivering technical presentations and educational courses on USP quality standards and reference material science for bio/pharmaceuticals
- Reviewing promotional materials and scientific publications developed by colleagues in other departments
Basic Qualifications
- 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
- Proficiency in English is required
Preferred Qualifications
- Biologics / biotherapeutics training and experience
- Self-motivated with ability to collaborate with colleagues in science and marketing and across geographies
- 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
- 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 biotherapeutics community
- Ability to travel
Job Classification
Industry: Pharma, Biotech, Clinical ResearchFunctional Area: Engineering Design, R&D,
Role Category: R&D
Role: R&D
Employement Type: Full time
Education
Under Graduation: Any Graduate in Any SpecializationPost Graduation: Medical-MS/MD in psychology, Any Postgraduate in Any Specialization
Contact Details:
Company: United StatesLocation(s): Hyderabad
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Keyskills: Health insurance Quality standards Material science Manager Quality Assurance Pharma Analytical Pharmacy Biochemistry Manager Quality Control Customer engagement
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