Manish Sethi Email & Phone Number

Durham, Nc, Us

Dublin, Ireland, Ie

• Managed teams of product development and tech transfer scientists for transferring products from R&D and potential clients for tech transfer, scale-up, and process optimization• Business leadership: determined capacity, resources constraints, technical constraints, and financial evaluation of new potential projects while ensuring safety, quality, and operational excellence• Project management for ongoing manufacturing and packaging operations of commercialized products• Primary liaison within the organization between BD, SC, Ops, Validation, Engineering, and QA to ensure development plans for new business opportunities and products from the potential clients

Durham, Nc, Us

•Set up teams and implemented new processes for product development, new project introduction, tech-transfer, process optimization, CQA and CPP determination, SUPAC, registration, process validation (PPQ), and commercial launch • Managed technical relationship between sending and receiving organizations, campaign monitoring and support, performance analysis and interpretation and investigation support• Led cross-functional tech transfer teams as a project manager for clinical supply and commercial projects

Salisbury South, Sa, Au

• Led process strategies, designs, QbD plans, batch records and protocols and supply chain for scale up, tech transfer and commercial manufacturing•Drove multiple simultaneous projects as a consultant in-house, for clients and at CMOs - by coordinating complex projects with the functional heads in Finance, Marketing, Pharm. Dev, QA, Supply Chain, Regulatory, Manufacturing and Packaging Operations•Led tech-transfer efforts, resource identification and management, scenario analysis, risk-mitigation strategies, process optimization, registration, validation, commercial launch, and on-market support• Assisted in process validation, equipment IQ/OQ/PQ, CI initiatives, deviations, root cause analysis• Maintained an understanding of the current FDA and ICH guidelines related to CMC and SUPAC activities

Somerset, Nj, Us

• Client interface for solid oral formulation, product & process development • Led project execution involving risk assessment, design, manufacturing, batch records, protocols and reports• Collaborated with QC, QA & engineering teams for design parameters, resolving process discrepancies • Managed multiple projects within budgetary and timeline restrictions

• Managed vendor relationships and accounts • Led external product development, tech transfer operations and supply chain managementParenteral Formulations:• Polymersomes based biological and small molecule formulation• Nanoparticle theranostic system for microbial and cancer cells• Peptide-polymer based vaccine development

Chapel Hill, Nc, Us

• One of the founding members (Outreach Coordinator) of UNC Graduate Consulting Club (Now Graduate Business and Consulting Club) • Co-chair of postdoctoral association of UNC-Chapel Hill• Successfully executed multiple preclinical projects with a focus on developing parenteral drug delivery systems for chemotherapeutics and immunoncology.Development of: • Controlled drug release (nanoparticle) formulations• Orphan drugs formulation development for cancer therapeutics• Cancer vaccine using polymer materials• PRINT® technology utilization for drug development• Lab and project management• Purchasing and procurement• Mentored and supervised lab techs, undergrads and other postdocs • Prepared manuscripts and grant proposals• Ensured compliance with: a. Lab Budget b. IACUC (Institutional Animal Care and Use Committee) c. EHS and Radiation safety requirements.

Lexington, Ky, Us

• Published 11 high impact papers in the filed of Bioanalytical and Nanoparticle Surface Chemistry.• Developed a sensitive in-solution analytical method to study the interactions of amino acids, small biomolecules and peptides on three dimensional surface of gold nanoparticles and nanorods.

Developed a diagnostic sensor by coating quantum dots with silica nanoparticles for in vitro fungal detection.Synthesized and characterized quantum dots, coated them with organically modified silica (ORMOSIL) nanoparticles and attached antibodies on the nanoparticle surface.Project TitleSynthesis of fluorescent ORMOSIL nanoparticles and their use as a diagnostic tool against C. neoformans

In

Independently developed a DNA-based sensor using fluorescence quenching of quantum dots with gold nanoparticles.

Purified multi-drug resistance CDR1 membrane protein (C. albicans)Prepared a gene disruption cassette and cloned of SNQ2 (membrane protein) in C. albicans.

Mba, Strategy And Business Analytics

Ph.D, Chemistry

M.S, Biomedical Sciences

B.S, Microbiology