U.S. Pharmacopeial Convention Jobs

Job Information

The U.S. Pharmacopeial Convention (USP) Scientist III - Bioassay in Hyderabad, India

Description

Summary of the Position

This is a hands-on, non-supervisory position in USP-India’s Biologics Bioassay laboratory. In this position, the Scientist will spend 70% of the time in lab and will perform in vitro assays for various biologics product classes such as recombinant proteins and mAbs, peptides, blood products etc. Scientists will be responsible for the hands-on execution of projects on collaborative testing of reference standards, characterization of biological products, method development, and validation for the development of standards (Documentary Standards, Physical Reference Standard & Performance Standards). Responsible for Inventory management and other supporting activities related to India biologics lab. The scientist will spend 30 % of their time in exploring opportunities to develop physical standards for functional assays, preparing reports and manuscripts and will play a major role in developing a road map for developing bioassay standards. This work will involve reviewing current assay platforms, industry requirements for standards, scope of standards in cell line evaluation and functional assays and identifying and evaluating opportunities for new physical standards.

Roles and Responsibilities

Aligns with USP’s mission, and complies with USP’s guidelines and other requirements

Performs analysis of biopharmaceutical test samples using a variety of methods such as cell-based bioassays, ligand binding assays, immunoassays, protein, and nucleic acid analysis

Develops and evaluates validated methods used for the measurement of biological attributes, develops validation protocols, and execute the validation plans. Prepares final report and presents data as applicable

Performs peer-review of data along with collaborative test and research reports

Identifies opportunities for new functional assay standards based on thorough research and formulate a plan to develop standards for various product class, platforms, and various stages of bioassay lifecycle of a biotherapeutic product. Prioritizes potential targets and identifies gaps

Keeps abreast of current trends and developments in related scientific fields, particularly in functional assays.

Works with technical writers to publish tech notes, white papers, or peer reviewed articles as applicable.

Evaluates and analyzes scientific reports and identifies next steps and key challenges. Plans and conducts research projects independently

Works with cross-functional teams within the organization to solve/support both technical and process-related issues.

Demonstrates strong technical skill, interest, and expertise in functional assays

Seeks out innovative ways to apply knowledge or skills to improve protocols and results

Actively engages overall project and ensures own work is aligned with overarching goals

Shares technical expertise with fellow lab staff and serves as a mentor for them

Attends scientific seminars and conferences

Follows QMS practices. Recommends improvements to systems and all other supporting activities.

Basic Qualifications

Ph.D. in Biochemistry or related Biological Science field with 2-3 years of relevant laboratory experience or M.Sc. in Biochemistry, or related Biological Science field with 7-8 years of experience in Bioassay/Functional assay.

An equivalent combination of education and experience may be substituted. Laboratory experience must include bioassay, potency tests, enzymatic assays, immunoassays, protein, and DNA analysis in general. Candidate must be experienced in bioassay development and validation following ICH, FDA, and USP guidelines

Preferred Qualifications

· Experience in cell culture techniques and cell-based bioassay. Knowledge in cell immunofluorescence methods including fluorescent microscopic based method and flow-cytometric method is a plus.

· Able to analyze and interpret data using appropriate statistical methods and calculations for relative potency determination, including but not limited to, PLA methods

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.

Strong writing skills and experience drafting technical reports related to project proposal, material characterization, method development etc.

Ability to learn new technologies and strong computer, scientific, and organizational skills

Ability to summarize and present data at meetings to a wide range of audiences

Must possess excellent written and verbal communications 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 of reference standards related to biopharmaceutical products/industry.

Experience with reference materials development is a plus.

Supervisory Responsibilities

None

Job Category Chemistry & Scientific Standards

Job Type Full-Time

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