Saikat Barik

• Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
• Cultivated a positive work environment that fostered employee engagement, increased retention rates, and boosted overall team morale.
• Improved project efficiency with strategic planning, resource allocation, and time management practices.
• Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
• Managed budgets effectively to ensure optimal use of resources while maintaining financial stability.

• Product handled: Solid Oral (IR, Sustained Release formulation, Capsule (Tablets in capsule, Pellets and Tablets in Capsules), Liquid (Suspension, Syrup), Dry Powder Suspension
• Nutraceuticals Product Developments
• Responsible for Pilot BE and Pivotal BE for ROW markets
• Review of Product Development report preparations as per QTPP, CQA, CPP and Risk assessment, Query response as per regulatory requirement of ROW product
• Review of Master Formulation Report, Review of OOS, OOT, Change control, Artwork evaluation, In process Finish Product Specification
• Communicating with Business Development team regarding New Product Initiation, Approval process.

Product handled: Solid Oral (Oral Peptide, IR, Sustained Release formulation, Capsule (Tablets in capsule, Pellets and Tablets in Capsules), Liquid (Suspension, Syrup), Dry Powder Suspension, Sterile Injection.

• DCGI filling of new product including BE study and all filling documents
• Development for BE/CT batches for DCGI filling
• Trouble shooting at Shop floor
• Responsible for Pilot BE and Pivotal BE for ROW markets
• Product Development report preparations as per QTPP, CQA, CPP and Risk assessment, Query response as per regulatory requirement of ROW product
• Preparation of Master Formulation Report, Review of OOS, OOT, Change control, Artwork evaluation, In process Finish Product Specification, Licensing application for DCGI filling.
• Developed strong working relationships with staff, fostering a positive work environment.
• Mentored junior staff members in their professional development by offering guidance/support in their assigned roles.
• Coordinated with vendors to ensure timely delivery of products and resolve any supply chain issues.

• Product handled: Solid Oral (IR Tablet, Dispersible Tablets, Taste masking ODT Tablets), Powder Formulation
• Preformulation Studies
• Development of new formulations as per WHO prequalified product
• Literature survey
• Trouble shooting at Shop floor
• Responsible for Pilot BE and Pivotal BE, Stability batch & Exhibit batch
• Product Development report preparations as per QTPP, CQA, CPP and Risk assessment, Query response as per regulatory requirement
• Preparation of Master Formulation Report, Review of OOS, OOT, Change control, In process Finish Product Specification.

• Product handled: Solid Oral (IR tablet, Delayed Release Tablets, Tablets in Capsules, Capsules) in Sterile Ophthalmic Dosage Form (Solution, Suspension, Ointment)
• Preformulation Studies
• Development of New formulations for ROW and Domestic market
• Literature survey
• Trouble shooting at Shop floor
• Responsible for Pilot BE and Pivotal BE, Stability batch & Exhibit batch
• Product Development report Preparations, To solve query of regulatory requirement.

• Chewable Tablet & Sachet Formulation, Taste masking formulation of ODT
• Film coating & Sugar Coating Formulation, Oral Liquid Formulation, Nutraceutical Product Formulation
• Pre formulation Studies
• Development of New formulations
• Literature survey
• Trouble shooting at production floor
• Responsible for scale up batch, stability batch & validation batch.

Dispensing of RM, IPQA checking of Liquid, Tablet & Capsule (Tand Online BMR filling

• Maintenance of documentation of all S.O.P, B.M.R's and others related document.
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