Om Srivastava

An accomplished innovative and quality driven professional with comprehensive knowledge and experience in pharmaceutical development, quality (QA & QC), chemistry, manufacturing and controls (CMC), regulatory, supply chain, assay development and compliance aspects of pharmaceutical product/ process development, tech transfer, IND, IMPD, eCTD, NDA writing, commercial manufacturing, technical operations and project management (planning and execution). Exceptional creative ability, strong verbal, written and interpersonal skills. Management of complex projects and multimillion dollar contract manufacturing organization (CMOs) with demonstrated ability to form a strong relationship with CMOs/CROs. Ability to work highly effectively in complex international matrix environments to support global product development initiatives. Background and experience includes:• Management of Pharmaceutical Development, CMC, Quality (QA/QC), Supply Chain, Assay Development, CMOs/CROs for the manufacturing of CTM and Commercial supply.• Project management and technical experience.• Commercial manufacturing and supply chain activities, management of API and drug product. • Packaging (container closure), solid dosage form, sterile injectable, sustained release, immediate release, coated pellets, capsules, liquid oral dosage, parenteral, transdermal, synthesis of API, chromatography, crystallization, fermentation and purification.• IND, CTA, IMPD, eCTD and CMC sections of Module 3 for NDA and EMA submissions.• Developed Products from inception to commercialization.• Exceptional problem solving skills in providing solutions to DS and DP formulation.• Design of Experiment (DOE/QbD) for API and drug product.• Budget management, staff management, due diligence and audit CMOs and CROs.• Scale up of pharmaceuticals from discovery to commercialization.• Product development, portfolio strategy, life cycle management, new product launch, PAI, technical transfers.• Development of technical and regulatory strategies aligned to corporate vision with emphasis on achieving goals right first time.• Identification of critical go/no-go hurdles to enable informed decisions.• License and due diligence activities• Responsible for regulatory writing for CMC and preparing responses to FDA and EMA.• Authored 75+ publications, patents and conference proceedings.• 1st Distinguished scientist for the province of Alberta, Canada