Ashok Ghadage

About Ashok Ghadage

Formulation and Development: Expertise in developing dosage forms considering drug chemistry, stability, and compatibility under regulatory norms to ensure timely completion of product development targets. Extensive experience in formulating and developing solid orals (immediate release and modified release tablets and capsules) and liquid oral forms (solutions and suspensions). Proficient in applying Design of Experiments (DoE) and Quality by Design (QbD) principles from lab trials to scale-up and exhibit batches for the US and European markets. Quality by Design (QbD): In-depth knowledge of implementing QbD, including Target Product Profile (TPP), Quality Target Product Profile (QTPP), Critical Quality Attributes (CQA), Design Space, Risk Assessment, Control Strategy, and DoE for generic drug products. Regulatory Affairs: Strong understanding of drug regulatory affairs, including Abbreviated New Drug Application (ANDA), New Drug Application (NDA), and dossier filings, stability testing, and International Council for Harmonisation (ICH) guidelines. Scale-Up and Exhibit Batches: Skilled in executing scale-up and exhibit batches, including the preparation of Batch Manufacturing Records (BMR), Master Formula Records (MFR), and Process Execution Protocols (PEP) for regulated markets. Documentation: Proficient in documenting all steps of formulation development, including product development strategy, stability study protocols, product specification proposals, and product development reports as per regulatory requirements (3.2.P.2). Patents and Technology Trends: Clear understanding of patents and new technology trends to achieve product excellence. Regulatory Guidelines: Thorough understanding of guidelines from regulatory agencies such as the US Food and Drug Administration (USFDA) and the European Medicines Agency (EMEA) and CFDA. Team Leadership: Experience in leading a team of 3-4 scientists, providing guidance and oversight in formulation development projects. Product Ideation: Innovative ideation of new products based on unmet needs, leveraging market research and technological advancements. 505(b)(2) Product Development: Expertise in 505(b)(2) product development, including oral solutions, suspensions, modified release dosage forms, and ophthalmic solutions, suspensions, and emulsions.

Experience

1. Senior Manager (Team Leader)

   Azurity Pharmaceuticals

   May 2024 — Present · Hyderabad, IN

   Leadership in 505(b)(2) Formulation R&D: Spearhead formulation research and development for the US market, focusing on solutions and suspension dosage forms.Guiding Modified Release Formulation Development: Lead the development of modified release formulations via the 505(b)(2) pathway, including tablets, capsules, and MUPS.Directing Ophthalmic Formulation Development: Oversee the development of ophthalmic solutions, emulsions, and suspensions via the 505(b)(2) pathway.Innovative Product Ideation: Drive the evaluation of technical feasibility, clinical and regulatory pathways, and facility requirements for new product ideas.Technical Leadership: Provide mentorship and technical guidance to junior formulation scientists, fostering a collaborative and innovative team environment.Strategic Program Management: Establish and manage program timelines and budgets, ensuring alignment with ELT approval and tracking expenses with finance and project management teams.Program Initiation and Execution: Coordinate the initiation of programs by arranging licenses, equipment, and necessary documentation, and execute experimental strategies with team members.Clinical Studies Oversight: Lead coordination with PM and CRO for clinical studies execution, ensuring adherence to timelines and regulatory requirements.Financial and Cross-Functional Coordination: Ensure compliance with procurement and accounting systems, and collaborate with regulatory, quality, packaging, and analytical teams for alignment and key deliverables.Decision-Making and Alliance Management: Work with PLM team and delivery captain for program-related decisions, evaluate partners and contracts, and manage communications with external partners.Tech Transfer and Compliance Leadership: Plan and execute tech transfers, clinical studies, submission preparations, and query responses, ensuring compliance with documentation and procedures.

Education

• Govt. College of Pharmacy, KARAD

  M.Pharmacy

  2011 — 2013

• Bharati Vidypeeth College of Pharmacy , Kolhapur

  Bachelor of Pharmacy (B.Pharm.)

  2007 — 2011

Skills

• Drug Delivery
• Anda & Nda Drug Development
• Formulation
• Pharmacovigilance
• Quality by Design
• Glp
• Clinical Research
• Pharmaceutical Industry
• Pharmacokinetics
• Abbreviated New Drug Application (Anda)
• Pharmaceutical Research
• Formulation Development
• R&D
• Technology Transfer
• Anda
• Pharmaceutics
• Clinical Trials