Chandra Sekhar Panchagnula
Land O Lakes,USA
Summary
To continue successful Research & Development Formulation practice in Oral Solid Dosage forms (Rx & OTC) and Oral liquid dosage forms with exceptional hands-on experience from Concept to Completion, where my qualification and experience can enhance organizational operational development, profit growth, mission objectives, efficiency, resource utilization and employee satisfaction. Formulation & Manufacturing expertise Technically sophisticated and Seasoned High-profile career spanning 23+ years-enhancing growth and profitability in R&D and Production arenas. Dynamic career reflecting pioneering experience and record-breaking performance in the pharmaceutical development industries. An experience well qualified professional, known for creative and facilitating high-quality R&D Formulation solution by using innovative technologies for a consistent record of delivering superior bottom line results. Solution –focused, multifaceted, exceptional experience guiding and managing all pharmaceutical development challenges encountered by fast-placed, aggressive, highly competitive and driven in exceeding organizational growth and profit objectives. Accomplished and recognized scientist with progressively responsible and diversified leadership experience in competitive pharmaceutical environments. Successful record of accomplishment in building research & development alliances. Pharmaceutical expertise with outstanding formulation development recognized rewards. Hardworking and passionate job seeker with strong organizational skills. Ready to help team achieve company goals. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
26
26
years of professional experience
Work History
Head of Formulation Research and Development/Production (Solid and Liquid Dosage Forms)
BELCHER PHARMACEUTICALS INC
08.2022 - Current
- Oversee the R&D and Production activities with respect to Formula Feasibility and finalization/Pilot bio studies/ANDA/Validation/ Commercial batches
- Oversee the Project Management activities related to all the departments (QC/QA/RA) for timely delivery of the project as per company targets and goals
- Oversees all the Analytical Lab activities with respect to the organization's products, projects, and programs
- Co-ordinate/ Communicate with the CRO team directly and finalize the strategies for Pilot/ Pivotal BE studies
- Co-ordinate/ Communicate with the third party for site transfer of projects
- Expert in reviewing the Bio study protocols and Bio Summary reports
- Coordinate and Communicate with the API Vendors and finalizing the API selection, negotiating the price, and in overall Procurement related activities
- Coordinate and Communicate with Excipient vendors and looks overall the Procurement related activities with respect to Submission/ Validation activities
- Technical assistance to support Regulatory team in answering the CMC queries to FDA
- Excellent exposure and knowledge in support, review and approve of SOP's / validation Protocols / Batch Manufacturing records / Batch Packaging records/ANDA Submission documents including QBDs (Quality Based Documents), QBRs (Question Based Reviews) / IQ/OQ and PQ of manufacturing equipment's/ ANDA submission documents / Bio summary reports/Justification reports/Change controls/Investigation reports/Sampling protocols/FDA CMC queries
- Excellent exposure in giving guidance and directing the scientist in implementing the DOE studies in formulation development
- Directs and Assist scientists in patent evaluation, formulation finalization, implementing formulation protocols and test procedures to ensure products meet the appropriate regulatory agency requirements, internal company standards and current industry practices
- Products worked on: Lacosamide Oral solution, Gabapentin Oral Solution, Glycopyrrolate Oral Solution, Thyroid tablets, USP, Testosterone Pellets, Itraconazole Oral Solution, Mycophenolate mofetil for oral suspension, Fosfomycin tromethamine granules for oral solution, Phenobarbital Oral Solution, Brivaracetam Oral Solution, Semaglutide ODT & Tezepatide ODT, Firocoxib Chewable Tablets
Vice President in Formulation research and development/Production
POLYGEN PHARMACEUTICALS INC
03.2016 - 07.2022
- Directs and Manages R&D, Production activities, with respect to Submission / Validation/ Commercial Batches
- Manages overall Analytical Lab activities with respect to the organization's products, projects, and programs
- Co-ordinate/ Communicate with CRO team directly and finalize strategies for Pilot/ Pivotal BE studies
- Directly Communicate with API Vendors and finalize API selection, negotiate pricing details, and looks overall Procurement related activities
- Trouble shooting of present and running products at manufacturing section
- Technical assistance to support Regulatory team in answering CMC queries to FDA
- Excellent in writing Justification reports related to organization's products, projects, and programs
- Directs scientists in developing and implementing experimental protocols
- Conduct inspections, checks, tests, and sampling procedures during formulation process
- Provide production and ANDA batches planning
- Provide documentation support for ANDA (Abbreviated New Drug Application) filings, including QBDs (Quality Based Documents), QBRs (Question Based Reviews) BMRs (Batch Manufacturing Records), BPRs (Batch Packaging Records), sampling protocols and reports
- Products completed: Amlodipine, Phentermine, Tramadol, Memantine, Levetiracetam ER tablets, Quetiapine ER tablets, Rosuvastatin, Darifenacin ER, Metaxalone, Bisoprolol, Clopidogrel, Acarbose, Triazolam, Montelukast, Oseltamivir, Voriconazole, valganciclovir & Valsartan
Manager in Formulation R&D
SCIEGEN PHARMACEUTICALS INC
05.2010 - 02.2016
- Manage and direct the research and development programs to meet organizational needs and to capitalize on potential new products
- Develop and implements research and development procedures and techniques and play dual design function role
- Literature survey observed extensive literature survey regarding formulations to be developed from Pharmacopoeia compendium/SPC/Orange book/ CDER/online networks/FDA websites
- Framing formulations/Infringing /non-Infringing method/patent search
- Developed formulations as PARA-I to PARA-IV
- Correlating the developed formulations and Innovator for Invitro and bio equivalency studies
- Resolved formulation/process/DOE/manufacturing issues/trouble shoot, identified, developed, optimized and executed for both exhibit batches (US) and commercial batches
- Improvement methods that focused on cost reduction, improved quality, and process standardization
- Documented and reviewed ANDA submission related documents (QBD, QOS)
- Coordinated and monitored quality policies and practices that ensured pharmaceutical and product management
- PRODUCTS COMPLETED AT SCIEGEN PHARMACEUTICALS INC- Nevirapine tablets, Hydrochlorothiazide tablets, Carisoprodol tablets Clopidogrel tablets, Fexofenadine HCl Tablets, Nevirapine Extended Release Tablets, Hydrochlorothiazide Capsules, Ciprofloxacin Tablets, Rosuvastatin Tablets, Atorvastatin Tablets, Metaxalone Tablets, Irbesartan Tablets, Irbesartan and Hydrocholoride Tablets, Quetiapine Extended Release tablets, Levetiracetam Extended Release Tablets, Omeprazole and Sodium Bicarbonate Capsules, Ezetimibe Tablets, Ezetimibe and Simvastatin Tablets
SCIENTIST-1
AUROBINDO PHARMA LTD
05.2004 - 04.2010
- Literature survey observed extensive literature survey regarding formulations to be developed from Pharmacopoeia
- Compendium/SPC/Orange book/ CDER/online networks/FDA websites
- Framing formulations/Infringing /non-Infringing method/patent search
- Developed formulations as PARA-I to PARA-IV
- Correlating the developed formulations and Innovator for Invitro and bioequivalence studies
- Resolved formulation/process/manufacturing issues/trouble shoot, identified, developed, optimized, and executed for both exhibit batches (US, Europe, and other non/low regulatory markets) and commercial batches
- Improvement methods that focused on cost reduction, improved quality, and process standardization
- Interfaced with all concerned departments like Analytical research, validation, stability to resolve both analytical, stability, formulation, and drug substances form issues
- Excellent exposure in framing technical data package and Technology transfer dossiers
- Excellent practical exposure on product optimization and Exhibit batches
- Drafting and Finalizing final Product development report for both US and Europe market
- PRODUCTS COMPLETED AT AUROBINDO PHARMA Nevirapine oral suspension for US market, Cefpodoxime Proxetil tablets and powder for oral suspension for US & EU market, Terbinafine hydrochloride, Pivmecillinam, Clopidogrel tablets, Fexofenadine HCl Tablets for US & EU market, Nafcillin and Oxacillin for US & EU market, ARV Double & Triple combination IR dosage form (NDA-Lamivudine and Tenofovir Tablets) (NDA-Lamivudine, tenofovir and Efavirenz tablets)
Project Trainee
ORCHID CHEMICALS & PHARMACEUTICALS
05.2003 - 04.2004
- Worked on the Project (Post Graduation Thesis Work) Formulation and evaluation of Mosapride Alginate beads as floating drug delivery systems
Manufacturing Trainee
BACTOLAC PHARMA LTD
06.1999 - 04.2002
- Worked as Manufacturing trainee and gained experience in cGMP practices and also got training on all operational activities of various equipment's like Blenders, Coaters, Sifters and Compression machine
Education
Master of Pharmacy - Pharmaceutics
Dr. M.G.R. Medical University
Chennai, Tamil Nadu, India05.2004
Bachelor of Pharmacy -
Dr. M.G.R. Medical University
Chennai, Tamil Nadu, India05.1999
Skills
- Pre-formulation Studies
- Project Management
- Bio Study Protocol design
- Vendor Management
- Procurement management
- Nutritional products
- Regulatory filing support management
- IQ/OQ/PQ/SOPs
- Process Validation
- Commercialization of projects
- Quality Compliance
- CGMP
- Process validation protocols
- CMC support
- Site transfer Projects
- CDMO's
- Project Costing
- Budgeting
- Production Planning
- MS office
- Excel
- Power Point
- Self-Directed
- Self-Motivated
- Excellent Communication
- Remote Office Availability
- Customer Relations
- Interpersonal Communication
- Interdepartmental Communication
- Organization
- Time Management
- Task Prioritization
Careeraccomplishments
- Developed over 40 generic products and for 23+ consecutive years for ANDA & consistently served as a top formulator in the generic industries including multi release dosage system.
- Utilized superior business skills in specializing to established three generic departments, thereby doubling revenue and earning several reorganization awards.
- Increased market share and contributed millions to bottom-line profitability by proficiently developing, introducing, and launching successful new products.
- Boosted high customer market satisfaction and realized 100% on-time delivery of assigned projects by applying solid communication, customer service, and organizational skills.
Personal Information
Visa Status: Green card
Publications
- Stable Compositions of Lamivudine, Tenofovir and Efavirenz Tablets, WO2009106960 A3, PCT/IB2009/000352, 09/03/09
- Stable dosage forms of lamivudine and Tenofovir Tablets, WO2009106954 A1, PCT/IB2009/000339, 09/03/09
Area Of Expertise
Expert Pharmaceutical Formulation Technology Professional with Comprehensive Rx & OTC GENERIC background in Product Development and Processes from Concept to Launch. R&D Management | New Multi Release Dosage Development | Scale-up | ANDAs' Manuf.| Support CMC Regulatory & Compliance | Multi-site Tech Transfer| Process Improvement | Team Leadership & Training | Project Validation | New product Development | Production Approval Process| Implementation on technologically innovative approach.
Activities
- Participated in Indian Pharmaceutical Congress in 2003
- Participated in Indian Pharmaceutical Congress in 2004
Timeline
Head of Formulation Research and Development/Production (Solid and Liquid Dosage Forms)
BELCHER PHARMACEUTICALS INC
08.2022 - Current
Vice President in Formulation research and development/Production
POLYGEN PHARMACEUTICALS INC
03.2016 - 07.2022
Manager in Formulation R&D
SCIEGEN PHARMACEUTICALS INC
05.2010 - 02.2016
SCIENTIST-1
AUROBINDO PHARMA LTD
05.2004 - 04.2010
Project Trainee
ORCHID CHEMICALS & PHARMACEUTICALS
05.2003 - 04.2004
Manufacturing Trainee
BACTOLAC PHARMA LTD
06.1999 - 04.2002
Master of Pharmacy - Pharmaceutics
Dr. M.G.R. Medical University
Bachelor of Pharmacy -
Dr. M.G.R. Medical University