Dipak Goyal

Experience

1. Project Lead

   Hikma Pharmaceuticals

   Nov 2020 — Present · Bedford, OH, US

   Spearheaded the development of injectable drug products (Vial, PFS, etc). • Led technology transfer activities, ensuring seamless transitions from lab-scale development to large-scale manufacturing ensuring compliance with regulatory and quality standards. • Acted as the technical lead and Subject Matter Expert (SME) for formulation and process development, providing strategic direction and overcoming technical hurdles during product development. • Authored and reviewed regulatory filings to ensure compliance with industry standards. Responded to FDA deficiency letters with thorough, timely solutions, securing regulatory approval.• Managed technical due diligence for evaluating new products from external partners, ensuring strategic alignment and feasibility. Acted as the primary liaison for external partners, fostering collaboration with CROs to meet project timelines and deliverables.• Led cross-functional communication and managed CMC project plans across Tech Dev, Manufacturing, Regulatory, Quality, and Supply Chain, ensuring alignment with strategic goals and timely execution.Key Accomplishments:• Led multiple projects resulting in successful regulatory approvals and on-time market submissions.• Directed a cross-functional team that completed a challenging technology transfer to commercial manufacturing with no major disruptions.

Education

• University of Massachusetts Lowell

  PhD

• University of Massachusetts Lowell

  Master of Science

• University Department of Pharmaceutical Sciences, Nagpur University

  Bachelor’s Degree