Senior Scientist I, Bioassay

Description

Brief Job Overview

This is a hands-on, non-supervisory position in USP-India's Biologics laboratory. In this position, the scientist will spend 50% of the time in laboratory and will perform bioassays and binding for various biologics product class such as recombinant proteins and mAbs, perform vaccine and cell and gene therapy (CGT) functional characterization assays, and viral assays. Scientist will be responsible for hands-on execution of projects which can be collaborative testing of reference standards, characterization of biological products, method development and validation for development of standards (Documentary Standards, Physical Reference Standard & Performance Standards). Remaining 50% of the time they will support report preparations and reviews, preparing presentations, supporting lab management activities, and audit readiness activities.

How will YOU create impact here at USP?

• Proficient in in vitro cell based relative potency assays, flow cytometry, qPCR and SPR binding assays.

• Experienced in functional activity and immunogenicity assays.

• Experienced in method qualification and validation, protocol, report writing and data presentation

• Plans and executes research projects independently. Evaluates and analyzes scientific reports and

identifies next steps and key challenges.

• Works with cross-functional teams within the organization to solve/support both technical and

process-related issues.

• Performs peer-review of collaborative testing reports and research reports

• Keeps abreast of current trends and developments in related scientific field.

• Shares technical expertise with junior colleagues and serves 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

• Supports lab management activities

• 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.

Who USP is Looking For?

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

• M.Sc. in Biochemistry, or related Biological Science field with 11-13 years of Industrial experience in biopharmaceutical product development and quality testing, relative potency assays, mAb functional assays, expertise in flow cytometry, and primary cell culture. 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, and QMS knowledge and experience.

Additional Desired Preferences

• Working experience in the biotechnology/biopharmaceutical 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

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.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Job Category Chemistry & Scientific Standards

Job Type Full-Time