Biswajit Bhunia , M Pharm , PhD

Being a doctorate in pharmaceutical Science, wish to associate myself with a growth-oriented organization, utilizing educational background and work experience to carve a niche in the pharmaceutical field. Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success.

• Best Performance award received for the scalable process developed (Coating process) for Mesalamine ER Tablet during First to file submission and successively delivered within time.
• Successive Launching of prestigious Metoprolol Succinate ER Tablets (MUPS) and got rich appreciation by chairman award.
• Improvisation of release profiling of Modified release MUPS (Tamsulosin ER caps 0.4 mg) for delivering the commercial campaign and got appreciation.
• Trouble shooting actively for developing technology like bilayer and Tablet in Tablet product, OROS trilayer with laser drilling technology (Paliperidone ER Tablet) critically execution and delivered FTF filing (Rejection control significantly)
• Received high performance award while working for Prevention of Hairy crack of MUPS Tablet (example: Esomeprazole GR Tablet 20/40 mg) from exhibit execution to successfully launched without quality issue.
• Best performance award received for handling of a tablet in Capsule (Carbamazepine ER Capsule) smooth execution and submission within time.
• Productivity improvised in double quantity during Powder filling of Duloxetine HCL.
• Delivered robust process by giving Ad hoc support for existing manufacturing processes of key launching product ($20M revenue) & got outstanding award.
• Successive improvement in productivity and yield by designing the compaction process of Cefuroxime Axetil USP Tab and received significant annual appraisal rating.
• Got appreciated for the cost-effective and alternate API vender development program for delivering several products timely and saved 20% cost (API).
• Implementation of QbD approach (process development) on few R&D products.
• Successively reduced Batch Manufacturing records bulkiness (meaningless) of demanding and valuable product, new system, checklist implementation for batch initiation, SOP revision as per ongoing audit experience.
• Key achievement - Awarded the highest appraisal rating in three consecutive years (’15-’17), amongst the top 5 % of performers.

• Research Paper work of "Formulation and Evaluation of Oro-dispersible Tablets of Amlodipine Besylate"
• Control strategy of generic loratadine orally disintegrating tablets 10 mg during scalable manufacturing. Innovations in Pharmaceuticals and Pharmacotherapy. 2016, 4(2), 189-195.
• Process development, evaluation and controlling of process parameters during formulation development of loratadine as an ODT by QBD concept. Innovations in Pharmaceuticals and Pharmacotherapy. 2015, 3(4), 727-749.
• Current view in quality by design towards manufacturing process control: Review. Journal of Chemical and Pharmaceutical Research. (Accepted).
• Recent Advance in Quality by Design: Review. Asian Journal of Pharmaceutics.

• Mylan Laboratories Ltd, R&D Hyderabad (Viatris), General Manager – Process Expert cum Manufacturing Science & Technology Lead. (R&D), June 2015, till date, Leadership role being a Process Expert / Technology transfer Lead centrally within R&D for delivering robust product and process (ANDA, High potent, Hormonal, Site transfer projects), to manufacturing units (multiple) across the globe. Trouble shooting for process, Process development and scaling up support from development to launching of specific products for smoothing the transfer of the technology to each manufacturing locations (India & Overseas unit). Regulatory query response support, Alternate API vender development and audit Support. Pilot plant / FDS Lab management, Budgetary activities, Departmental Training coordinator is an additional responsibility.
• Aurobindo Pharma Ltd, Hyderabad, Head, Technology Transfer, July 2014, June 2015, Being a head Department, I was responsible for Smooth Technology Transfer /Process Development / Trouble shooting / Alternate vender development of Solid Oral Formulations with having a Challenging Team (more than 72 members) for multiple units. Spirit focusing ANDA filling / Site Transfer / Alternate API / Trouble Shooting / Commercial launching and process smoothness / Exhibit Packing & PDL Analytical Lab. Acquired knowledge of commissioning a new pilot / scale up labs including selection of process equipment’s and technical man / scientist sourcing, training.
• Jubilant Life Sciences, Noida, Sr. Group Leader, PDS & Technology Transfer /Validation, February 2012, July 2014, I was leading a team of 23 members for smooth technology transfer/ Validation of the R&D projects to manufacturing units for regulated market (ANDA, Global submission) and supported actively for audit.
• Wockhardt Research Centre, Aurangabad, Sr. Research Scientist (Product Development and Technology Transfer), October 2006, February 2012, I was responsible for Process Development / Technology transfer / Commercial luanching and monitoring of the complex ANDA projects for smooth technology Transfer (Solid Orals and Parenteral dosage) with a small team (4 members) for regulated market submission and validation batches.
• Torrent Research Centre, Ahmedabad, SCIENTIST II (Product and process Development and Technology Transfer), January 2005, October 2006, Being a formulation Scientist, responsible for Execution, monitoring and documentation for developing and Technology Transfer of Solid Orals and Parenteral dosage (liquid and lyophilized dosage) for regulated market submission (ANDA and ROW).
• Lupin Limited, Aurangabad, Executive (Process Development and Manufacturing), December 2001, January 2005, Independent handling of Tablets & Parenteral Department. Process Development, Process Validations pertaining to manufacturing of Tablet & Injectables.
• Samrudh Pharmaceuticals Pvt. Ltd, Mumbai, Production Chemist, July 1999, December 2001, As a Production Chemist I was responsible for the entire process of manufacturing on State-of-the-art compact tunnel & automatic line for Ampoules, Vials and Lyophilized product. GMP Audits and compliance reports and preparation of protocols and SOP’s.

• Dr. Gautam Mahuri, Phd, President R&D, Ipca Pharmaceuticals R&D, Mumbai (India), +918800523331
• Mr. Santanu Chakraborty, Head Formulation Development (Sr. Vice President), Mylan R&D, Hyderabad (India), +918008001535
• Dr. Rahul Dabre, Head, Pharma Research, Alembic Pharmaceuticals Ltd, Hyderabad, 09822643570