The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
Post: Senior Scientist II, Biologics
Job Description
Function of the Position:
This is a hands-on position in which the incumbent is responsible for his/her individual lab activities in the Bioanalytical Lab of BBL-India. The candidate would be responsible for method development and validation of analytical tests and performing advanced analytical characterization studies for biological molecules in a regulated work environment i. e. R&D with ISO accreditation.
Roles and Responsibilities:
- Assists Manager in planning, implementing and evaluating laboratory procedures/systems on assigned projects
- Demonstrates strong skill and expertise in the area of analytical method development and validation of biochemical techniques including but not limited to electrophoresis, spectrometry, chromatography, etc.
- Thorough hands-on experience on high-end characterization techniques such as QTOF-MS, CD, MALS and Protein Sequencer
- Develops and maintains regular interaction with colleagues from different USP sites across the world
- Participates in ISO: 9001 and ISO: 17025 audits
- Organizes and plans work as per timeline and project priority
- Participates in training programs for cross functional teams as well for external participants
- Supervises junior team members to train, review as well as guide when required
- Conducts test procedures independently in a timely manner
- Reviews, and evaluates scientific literature in the relevant technical area
- 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
- Performs additional duties as assigned
Required Skills
Minimum Requirements for Senior Scientist II:
Ph.D. or M. Sc. degree in Biochemistry, Biotechnology or related area with minimum 7 years of relevant experience in biopharmaceutical analysis, including laboratory experience in compendial methods.
Knowledge, Skills and Abilities:
Person with Research and Development experience (non QC) in Biopharmaceutical Industry is must. Excellent technical writing and oral communication skills required. An ability to communicate effectively with, both internal and external, customers is a must. A working knowledge of general analytical methodologies such as HPLC, GC, IC, UV, IR, MS, wet chemistry in the field of biopharmaceuticals as well as GLP/ISO/17025 required. Knowledge of USP reference standards and testing methods or biopharmaceutical industry in-house reference standards qualification is highly desirable. A thorough understanding of basic organic chemistry would be a plus point. Working knowledge of relevant computer applications, especially Microsoft Word, Excel and Oracle ERP, required.
Additional Information:
Experience: Min. 7 years
Qualification: Ph.D. or M. Sc. degree in Biochemistry, Biotechnology
Tracking Code: 429-679
Location: Hyderabad, Andhra Pradesh, India
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D
End Date: 20th September, 2015
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