Dr. SATYABRATA BARIK

Principal Scientist – Formulation Development* _Lead scientific strategy & execution for complex generic drug products from concept to commercialization. Drive QbD, DoE, and novel drug delivery approaches for FTF, MUPS, DR/ER, NCE-1 programs. Oversee scale-up, tech transfer, and regulatory response management. Mentor junior scientists and build technical capabilities within the team._ *Key Responsibilities:* 1. *Scientific Leadership*: Define formulation strategy for complex products - sterile injectables, pellets, osmotic systems, modified release 2. *QbD & Innovation*: Implement Design of Experiments, risk assessment, and advanced formulation technologies 3. *Development to Scale-up*: Lead lab → pilot → commercial scale-up with robust process understanding 4. *Regulatory Excellence*: Author technical sections, respond to agency queries, ensure data integrity 5. *Mentorship*: Guide http://M.Pharm/PhD .

To lead multiple projects as per the department needs. Solid Oral Dosage form for Regulatory Markets (USA- ANDA & EU). Expertise on design of experiments (DOE) by design expert software independently and carryout scientific work with the knowledge of the technology. Handling of NCE-1, MUPS technology, Palletization technology, in- Vitro in-Vivo correlation Complex generic molecules, genotoxicity & Nitrosamine risk Evaluation,

Working on Solid Oral Dosage form for Regulatory Markets (USA- ANDA ,EU and ROW) Expertise on DR oral suspension, Liquid oral suspension. Formulation development strategies for NCE-1 and Para IV approaches. Risk Assessment of the formulation and process to anticipate and control the risk parameters so as to build quality in to the product right at the stage of development and technology transfer.

• Expertise on Solid Oral Dosage form for Regulatory Markets (USA- ANDA & EU)

To actively supervising and managing a team for performing product development activities of solid oral dosage forms. Formulation development activities and processes for solid dosage forms.(US, Europe, ROW) Design of Experimentation and Quality by Design (QbD) aspects for formulation development

Formulation Development of solid orals for US and Europe market. Plans work independently based on specific objectives. Scale-up and technology transfer experience to pilot/commercial scale.

Formulation and Development for Solid Oral Dosage form like ER tablets, Softgel capsules ,CR Tablets( OROS Technology), for Europe & US(ANDA)Market (Para-III and Para-IV Projects)

I was working as Research Associate in Formulation Development Dept.for Solid Oral Dosage form for Regulatory Market.

I was working as an Executive in Formulation Development Dept. for NDDS products for solid oral dosage form and liquid injectables and soft gelatin capsule.