Career in USP for the post of Scientist III

The United States Pharmacopeia (USP) is a non–governmental, official public standards–setting authority for prescription and over–the–counter medicines and other healthcare products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP's standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years.

Post : Senior Scientist III, Bioanalytical

Job Description
This is a hands-on, scientific and supervisory position in USP-India’s Bioanalytical Laboratory. In this role, the incumbent delivers sustained contributions that result in innovative product and process technologies for USP. The incumbent will contribute to the scientific experience and work ethic of the laboratory through a broad range of technical knowledge and research experience. The incumbent will independently lead and contribute his/her own observations, and scientific inputs to projects. The incumbent at this level will execute work at bench level.

Roles and Responsibilities:

Provides scientific thought in ideating and leading R&D projects aimed at development of standards for Biologics product class (Therapeutic Monoclonal Antibodies, Proteins and Peptides) and publications.
Demonstrates strong skill and expertise in the area of analytical method development and validation of physicochemical and structural characterization of Biologics product class including but not limited to advanced technologies in Chromatography, Capillary electrophoresis, Colorimetric assays, Immunoassays, Protein sequencing, Mass spectrometry, Circular Dichroism, Fluorescence Spectrometry etc.
Extensive hands-on experience on high-end characterization techniques such as Q-TOF-MS, LC-MS/MS, CD, MALS and Protein Sequencer.
Reviews, evaluates and stays up-to-date with scientific literature/trends in the relevant technical area.
Routinely applies personal experience, academic training, and technical insights to solve complex problems in the laboratory.
Assists Director in planning, implementing and evaluating laboratory procedures/systems on assigned projects.
Develops and maintains regular interaction with colleagues from global sites.
Regular interaction with support service group on site to enable smooth functioning of lab.
Adheres to USP’s Quality Management System and participates and contributes in ISO 9001 and ISO 17025 audits.
Participates in training programs and actively engages and contributes in collaborative joint projects.
Supervises team members and provides training and guidance when required.
Conducts test procedures independently in a timely manner as and when required.
Prepares project plans, reports and reviews reports as per requirement.
Seeks out innovative ways to apply knowledge or skills to improve protocols and results.
Reviews all testing and analysis records of experimental data, ensuring clarity and authenticity in transcription of results and calculations.
Demonstrates a strong desire to continue learning and enhance personal capability.
Works with the other functional managers in the department and the Vice-President to enable smooth and efficient functioning of the department.
Mentors and manages team members, charting their professional growth within the organization.
Performs additional duties as assigned.

Required Experience
Ph.D. or M.Sc. degree in Biochemistry, Biotechnology or any other related area with minimum of 12 years of experience in Analytical R&D of biopharmaceutical, including laboratory experience in Compendial methods.
Candidate should have minimum 2 years of managerial experience.

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Required Skills

Excellent technical writing and oral communication skills required.
An ability to communicate effectively with, both internal and external, customers is a must.
Strong scientific knowledge and working experience in analytical technologies such as HPLC/UPLC, 2D-LC MS/MS, Capillary Electrophoresis, Peptide Mapping and Protein Sequencing in the field of biopharmaceuticals as well as working experience of GLP, ISO 9001 and 17025 is required.
Hands on analytical experiences with therapeutic monoclonal antibodies will be preferred.
Excellent experience with impurity profiling, and characterization will be considered.
Knowledge of USP reference standards and testing methods or biopharmaceutical industry in-house reference standards qualification is highly desirable.
Experience in leading and independently spearheading Analytical R&D projects is desirable.

Additional Information:
Experience: 12 Years
Location: Hyderabad, Andhra Pradesh, India
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D
End Date: 25^th May, 2017