Hari Ramanathan Email & Phone Number

Lawrence Township, Nj, Us

Support commercial cell therapy stability program by providing quality oversight and management of cell banks, plasmids, vectors and drug product stability studies.• Support stability strategy and implementation for Global Product Quality across teams and processes.• Lead and manage all aspects of stability program across multiple projects, including initiating and managing stability studies, protocol development, data monitoring, trending, and reporting.• Collaborate with project teams to assess stability commitments, sampling and testing requirements, and stability specifications as applicable.• Support regulatory submissions and response to questions from Health Authorities.• Manage stability related deviations, investigations and/or CAPA's

Lawrence Township, Nj, Us

Provide technical and quality compliance support for cell therapy viral vector. Support lifecycle management of process, specifications, and testing from development through filings, commercialization, approval, and beyond.Implement global changes with respect to product quality.

We help medical product and pharmaceutical industry clients systematically identify challenges and provide solutions to regulatory compliance related issues. Please visit www.PICAssociates.net to learn more.

Support Quality Management Systems project in Lower Middle Income Country clientsManage Global Health projectsNew business expansionTrain on medicines quality and testingProvide technical assistance on Laboratory system strengtheningManage international networks of Quality Control labs in Asia and MENA regions

Managed global health projects in Africa and AsiaManaged Medicines quality testing programsImplemented training programs on medicines quality and testingProvided technical assistance on safety and quality of medicinesTrained and assisted National Drug Testing labs to achieve QC ISO 17025 and WHO Pre-qualification guidelinesManaged international networks of QC labs in LAC, Asia and Africa and North Africa

Developed new monographs and prepared revisions to existing monograph content in accordance with established SOPs, organizational practices and procedures; Evaluated monograph tests, procedures and acceptance criteria; Collaborated closely with a team of high-performing scientists responsible for the development and revision of documentary standards; Worked with USP staff, regulatory bodies, stakeholders, and other pharmacopeias as related to monograph development;Provided information to the relevant USP Expert Committee(s) in support of monograph development; Served as a mentor for other staff and leads training efforts; Prepared manuscripts for publication by USP (e.g., stimuli articles) or in peer-reviewed journals; Represented USP at scientific conferences/meetings, outreach visits and other events sponsored by USP and/or pharmaceutical industry and regulatory agencies; Participated in the development and/or review of USP’s professional education course materials and may serve as an instructor; Collaborated closely with other departments on monograph-related issues.

New Brunswick, Nj, Us

New Brunswick, Nj, Us

Master Of Business Administration (M.B.A.), Business

Master Of Science, Chemistry

Master Of Science, Chemistry

B.Sc, Chemistry