The U.S. Pharmacopeial Convention (USP) 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 Scientist II, Dietary Supplements & Herbal Medicines
Brief Job Overview
• The summary should be a brief, high level description of the job responsibilities. Include 3-5 sentences that give an overview of the position. It is not an all-inclusive description.
• This is a non-supervisory hands-on, highly technical position that supports Dietary Supplements standard-setting activities by developing quality standards with focus on non-botanical dietary ingredients (such as small molecules, mineral salts, oils, proteins, probiotics) for use in dietary supplement dosage forms.
• The incumbent is responsible for developing and revising quality standards for dietary ingredients/supplements, and responding to internal and external queries related to dietary supplements in USP-NF.
• These activities require the critical evaluation of relevant scientific documents and other information, the performance of literature searches on related topics, and the development and drafting of pertinent documents for other scientific staff and/or Expert Committee review.
• The incumbent liaises with expert committee members in the critical review of analytical validation data, and other regulatory and laboratory data to assess suitability of proposed methods and reference standards.
• The incumbent provides technical input to other DSHM scientists
• The incumbent recognizes when additional expertise is needed and he/she has the ability to put together and manage advisory panels.
• The incumbent also closely follows the work in areas of pharmacopeial standards other than dietary supplements so that collaboration and exchange of information is seamlessly accomplished and made available when needed.
• He/she establishes and maintains relevant contacts outside of USP, stays abreast of new findings, and informs other scientific staff of new developments in dietary supplement quality methodologies.
• The incumbent may act as a liaison between Expert Committee and interested parties from government, academia and industry on issues pertaining to standards for dietary supplements.Job Description
• Executing the analytical tests allotted by Project Leader or Group Leader.
• Responsible for review and approval of the test protocol, test kit assigned by team or group leader if required.
• Supporting Verification, GPH, PQM, stability and other departmental teams in terms of testing and project review whenever needed.
• Responsible for mentoring and training juniors in team for day to day activities
• Responsible for sample archival, sample tracking and chemical inventory tracking in the laboratory.
• Coordination with group leader to ensure completion of the projects allotted to the team.
• Responsible for the initial review of the project reports, documents and assisting the group leader when required.
• Responsible for completing the project as per the timelines and troubleshoot the scientific aspects of the projects on need basis.
• Responsible for preparation and review of SOPs, protocols, reports etc.
• Responsible for performing the calibration of the equipment as per the schedule.
• Responsible for preparing, executing, and completing IQ/OQ/PQ of new instruments.
• Ensuring that the chemicals and column etc. are available for the projects and forward the purchase requisitions.
• Taking up any additional responsibilities assigned by group leader from time to time.
• Ensure all lab safety and GLP practices are maintained in the lab and participate actively in the internal and external audits and certification.
• Responsible to maintain and follow QMS and should handle incidents and deviations.
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 Scientist I: Ph.D. with 8 years, an MS degree with 10 years, or a Bachelor’s degree in chemistry, pharmacy, Pharmacognosy or a related field with 15 years of industry experience.
Senior Scientist II: Ph.D. with 10 years, an MS degree in Chemistry, Pharmacy, Pharmacognosy or a related field with 12 years of industry experience.
We especially welcome applications from those who hold historically marginalized and/or underrepresented identities. This job description provides a portrait of an ideal candidate. Candidates who possess many, though perhaps not all, qualifications are encouraged to apply.
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.
• Familiarity with up-to-date chemical and microbiological analytical techniques
• Experience with developing monographs and general chapters.
Familiarity with probiotics, and proteins highly desirable.
• Experience in one of the following areas is desirable: dietary supplement regulatory affairs, food ingredients/dietary ingredient analysis, food/dietary supplements analysis, biochemical analysis, microbiology.
• Ability to establish and nurture relationships with individuals of varying backgrounds and learning styles.
• Able to operate independently where appropriate, yet understands when to escalate issues and how to establish effective working relationships.
• Strong presentation and communication skills (written and oral).
• Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills.
• Knowledge of internet and electronic database searches helpful. Practical experience in analytical techniques is required.
• Knowledge of the dietary supplement industry and the associated regulatory framework is essential. Ability to prioritize tasks and manage multiple projects simultaneously.
• Ability to share technical information with non-technical or non-scientific staff, and to communicate effectively with representatives from dietary supplement companies, government, and academic institutions.
Experience : 5+ years
Qualification : Ph.D, MS degree
Location : Hyderabad
Industry Type : Pharma / Healthcare/ Clinical research
End Date : 30th September, 2023
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