USP is proud to be an equal opportunity/affirmative action employer. Employment selection and related decisions are made without regard to sex, gender identity, race, age, disability, religion, national origin, color, veteran status or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
Post : Scientist III, Bioassay
Brief Job Overview
This is a hands-on, non-supervisory position in USP-India's Biologics Bioassay laboratory. In this position, the scientist will spend 80-100% of the time in laboratory and will perform binding assays by SPR for various biologics product class such as recombinant proteins and mAbs, perform vaccine and cell and gene therapy (CGT) characterization assays, viral assays, and molecular biology activities like DNA/RNA extraction, advanced PCR technologies and agarose gel electrophoresis etc. for mAbs, CGT and vaccine products. Scientist will be responsible for hands-on execution of projects on collaborative testing of reference standards, characterization of biological products, method development and validation for development of standards (Documentary Standards, Physical Reference Standard & Performance Standards). Responsible for supporting activities related to India Biologics laboratory.
Job Description
• Performs in vitro cell based assays and binding assays using Biacore.
• Performs PCR, RT-PCR, qPCR, ddPCR and gel electrophoresis etc. for mAbs, vaccine and CGT products·
Develops and evaluates methods used for the measurement of biological attributes, develops validation protocols, and execute the validation plans. Prepares final report and presents data as applicable
• Evaluates and analyzes scientific reports and identifies next steps and key challenges. Plan and conduct research projects independently
• Works with cross-functional teams within the organization to solve/support both technical and process-related issues.
• Performs peer-review of data along with collaborative test and research reports
• Keeps abreast of current trends and developments in related scientific fields, particularly in functional assays, binding assays, impurity analysis in mAbs, CGT and vaccines.
• Demonstrates strong technical skill, interest, and expertise in binding, functional and viral assays
• Actively engages in overall project and ensures own work is aligned with overarching goals
• Shares technical expertise with junior fellow lab staff and serve as a mentor for them
• Seeks out innovative ways to apply knowledge or skills to improve protocols and results
• Assists team lead in planning, implementing, and evaluating laboratory procedures/systems
Supports in departmental trainings as applicable.
• Attends scientific seminars and conferences
• Follows GLP and QMS practices. Recommend improvement to systems and all other supporting activities as assigned by the team lead. Participates in internal and external audits.
• Aligns with USP's mission, and complies with USP's guidelines and other requirements
• Performs other duties as assigned.
Candidate Profile
• M.Sc. in Biochemistry, or related Biological Science field with 6-8 years of Industrial experience in Bio pharmaceutical product development and quality testing, potency assay, mAb functional and binding assays (using Biacore) and molecular biology techniques. Able to analyze and interpret data using appropriate statistical software/methods and calculation for relative potency determination.
• An equivalent combination of education and experience may be substituted. Laboratory experience must include expertise developing and validating assays, technology transfer for monoclonal antibodies and vaccine testing, ELISA, advanced PCR techniques, viral assays.
• Working experience in the pharmaceutical and/or biotechnology industry strongly preferred
• Demonstrated research, technical, and analytical skills, as well as the ability to take highly technical scientific information and make recommendations
• Ability to learn new technologies and strong computer, scientific, and organizational skills
• Good written and verbal communication skills, time management skills as well as interpersonal skills
• Results driven with demonstrated successful outcomes
• Individual must possess the ability to handle multiple priorities in fast-paced environment
• Knowledge/participation of reference standards development related to bio pharmaceutical products/industry
• Experience with reference materials development is a plus
Additional Information
Experience : 6-8 years
Qualification : M.Sc. in Biochemistry
Location : Hyderabad
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Bioassay
End Date : 30th March 2024
See All M.Pharm Alerts B.Pharm Alerts B.Sc Alerts Telangana Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
.png)
