Senior Technical Project Manager @ The Clorox Company
Ph.D., Analytical Chemistry @
Purdue University, West Lafayette, IN
Experienced analytical chemist and manager with strong technical knowledge, business acumen and consumer focus. Combined 17-yrs experience in bio-pharmaceutical, chemical and consumer goods/healthcare companies. Technical expertise in in vitro and in vivo testing and development of prescription drugs (small molecule, peptide, antibody), OTC topical drugs (skin care & antisepsis) and synthetic polymers & agro-chemicals. Effective people management,
Experienced analytical chemist and manager with strong technical knowledge, business acumen and consumer focus. Combined 17-yrs experience in bio-pharmaceutical, chemical and consumer goods/healthcare companies. Technical expertise in in vitro and in vivo testing and development of prescription drugs (small molecule, peptide, antibody), OTC topical drugs (skin care & antisepsis) and synthetic polymers & agro-chemicals. Effective people management, communication & leadership skills.
Head of Analytical Chemistry @ Head of analytical chemistry group supporting various discovery and product development projects in Cleaning & Specialty divisions (including Healthcare)
- Manage chemistry lab and personnel performing ELISA bioassays, Separations (IC, GC, and LC), Spectroscopy (FTIR, UV, ICP/AAS, NMR, GCMS, and LCMS), Microscopy (HR-SEM), Physical characterization (Rheometry, DSC, TGA, Tensiometry & particle-size) & Wet chemistry analysis.
- Support Product testing from early proof-of-concept to launch. Collaborate and coordinate closely with Marketing (claims support, competitive product testing), Regulatory (EPA/FDA compliance), Outsourcing (GLP/GMP testing) & Manufacturing (plant test method transfer and validation).
- People management – able to motivate, mentor and lead diverse group of senior staff. Responsible for daily supervision, technical troubleshooting and Performance Management Process (PMP) including compensation. Hiring manager for junior (technician) up to senior (PhD) level positions.
- Actively participate in developing and implementing broader organizational strategic plans, operational goals and business initiatives such as Lean R&D (Agile Innovation), Succession Planning & Talent Management. Effectively interact with and influence senior leadership across functions. From November 2012 to Present (3 years 2 months) Lead Research Scientist @ Group leader and Manager of mass spectrometry labs supporting early-stage preclinical R&D
- Supervised daily lab operations (GC, LC, SEC, affinity, preparative chromatography, MS and spectroscopy) and up to 6 scientists. Wrote and ensured compliance with SOP and quality guidelines. Supported discovery, development, formulation and pilot-plant groups. Working knowledge of metabolism, PK/toxicology and FDA GLP/GMP regulatory process.
- Established and managed a large bio-molecule characterization lab for structure characterization, stability testing and animal PK studies of intact antibody-drug immuno-conjugates (ADC), PEGylated peptides and drug-peptide conjugates for oncology and wound-repair projects.
- Established and managed bio-marker LCMS lab performing diagnostic and mechanistic in vitro assays; medium throughput label-free target enzyme inhibition and CyP inhibition assays and biomarker analysis in biological media and animal tissue. Performed high-throughput profiling, fractionation and identification of small-molecule metabolites produced by biotransformation.
- Established novel technology platform based on HP-TLC, UV and LC-MS for characterization of complex botanical (herbal) extracts for product development, CMC and quality control. Helped develop and implement preclinical analytical CMC strategy (up to IND filing) for OTC botanical drugs.
- Experience in new technology scouting, evaluation and implementation for antibody and peptide analysis including purchase of equipment (>$2M) and scientific software (>$100k).
- Lead user on a multi-year Laboratory Information Management Systems (LIMS) project connecting 5 R&D sites (Europe & US). Participated in vendor selection, specifications, testing, roll-out & training.
- Global technical lead (2008 & 2009) of Analytical Working Group. Promoted knowledge sharing, collaboration and method harmonization across 9 R&D sites in Europe and the US. From September 2000 to October 2012 (12 years 2 months) Senior Scientist @ Analytical scientist in the Analytical Technology Center. Worked on GLP analysis of agro-chemicals, biocides and formulations and MALDI-Tof analysis of synthetic polymers (e.g., poly-acrylates). From 1998 to 2000 (2 years) Post-doctoral Research Scientist @ Scientist in the Chemistry Division under Dr. John Callahan and Dr. Steve McElvany. Developed laser desorption and MIMS instrumentation and methods for ultra-trace analysis of semi-volatile compounds in water. From 1997 to 1998 (1 year) Washington D.C. Metro Area
MBA, 4.0/4.0 @ Temple University - Fox School of Business and Management From 2011 to 2013 Ph.D., Analytical Chemistry @ Purdue University, West Lafayette, IN From 1992 to 1996 B.Sc., Chemistry @ University of Bombay, INDIA From 1989 to 1992 Manish Soni, PhD MBA is skilled in: Drug Discovery, Cross-functional Team Leadership, High Throughput Screening, LC-MS, Protein Chemistry, In Vitro, Analytical Reasoning, Oncology, Antibodies, FDA, Laboratory Automation, Mass Spectrometry, Pharmacokinetics, Biomarkers, Drug Development
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