Scientist Iii

**Description**

**Who is USP?**

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.

**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 in vitro cell based assays and binding assays 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.

**How will YOU create impact here at USP?**
- Performs in vitro assays for mAbs, vaccines and cell and gene therapy products.
- 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
- 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.
- Aligns with USP's mission, and complies with USP's guidelines and other requirements

**Who USP is Looking For?**

M.Sc. in Biochemistry, or related Biological Science field with 7-10 years of Industrial experience in Bio pharmaceutical product development and quality testing, potency assay, mAb functional and binding assays. 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.

**Additional Desired Preferences**
- 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
- Experience with handling Biacore is a plus

**Supervisory Responsibilities**

No.

**Benefits**

USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing is protected.

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