Leading end-to-end product process development, API development to commercial launch, working in-house or with CDMO organizations. Building/leading diverse, cross-cultural and cross-functional teams. Optimizing development, process, scale-up, site transfers, product launches – driving efficiency, eliminating redundancy.Technologies: solid/liquid orals, dry/wet granulation, fluid bed processing, High/low shear granulations, encapsulations, compressions - experienced in abuse-deterrent technologies, spray congealing techniques.Experienced professional with proven expertise in complete development and management of Pharmaceutical R&D operations, project management, scale up, technology transfer and technology management, and process excellence in the Pharmaceutical Industry for Solid oral and Liquid oral drug products. Experience in the selection of business partners and management of projects from CRO/CMOs for pharmaceutical drug products. Enthusiastic and Participative leader managed diverse teams, collaborating with various functions such as R&D, Analytical, Production, Quality, Business Development and Regulatory Affairs to drive projects successfully. Have developed knowledge and skills in product development activities in the area of MR, ER, Abuse Deterrent Dosage forms, Semisolids (Gels, Ointments, Creams etc), Liquid Fill Hard Shell Capsules, Tablet in Tablet, Multiparticulate Dosage forms, Liquid Orals, Powder for Reconstitution, Multilayered tablets (compression and coating) and HME technologies. Experience in Documentation and Data management practices, design of production flow activities to reduce product costs and drive productivity. Skilled in selection and evaluation of appropriate technologies needed for pharmaceutical drug development and commercialization. Experienced in selection and evaluation of regulatory approaches for drug product filing. Specialties: Business intelligence, communication skills, technology implementation and management, marketing, leading and implementing change, process engineering, procurement, protocols, research, validation, scale up, tech-transfer, regulatory, quality assurance, data integrity, data management, quality audits, continuous improvement.
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Reviewer And Staff Fellow Opq, Opma CderFdaMason, Oh, Us -
Reviewer / Staff Fellow Opq, Opma CderFda Jan 2023 - PresentSilver Spring, Maryland, United StatesManaging Integrated Quality Assessment on ANDAs and NDAs for drug products including site assessments & Life Cycle Management.
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Senior Manager, Global Innovation Oral Care QaProcter & Gamble Jan 2021 - Feb 2023Mason, Ohio, United StatesManaging QA for Global Innovation Oral Care Portfolio, leading through Monograph Reform or NDA, meeting global regulatory requirements for product approval. Currently managing 5 projects ($21M+)• Successfully approved 3 products in multiple studies; 30+ clinical batches/study protocols (10 multi-center trials) all within the first year• Manage the release of new oral care rinse and toothpaste products• Oversee the creation of all Monograph and other documents in concert and compliance with the USFDA and international regulations• Manage the review and approval of batch making filing, labeling, and randomization records • Reduce costs by $10M+ yearly by reviewing audit reports, supply chains, distribution channels, distributors for regulatory status, manufacturing sites for regulatory compliance • Assess/improve quality initiatives for divisions in Europe, China, North, South, and Latin American• Implement GPS strategy regarding CMC and provide QA strategies in Europe and North America • Collaborate on the plans for product filing with functional and technical team representatives • Build and lead cross-functional teams with R&D, Manufacturing and Process Development, Product Supply, Clinical, and Global Innovation Diamond Management• Train key staff, including seven team members on Monograph reform efforts, manufacturing executive staff on data integrity and recordkeeping, reducing deviations by 5+%• Perform QA Audits of data regarding CMC, ensuring they are accurate, traceable, and complete• Ensure that the CMC commitments are adequate per process capability for the desired standard of product quality in collaboration with Product Development, Product Supply functions• Ensure adequate and appropriate technical review of CMC documents and help resolve all issues -
Senior Scientific Leader / Manager R&DPatheon Jun 2016 - Jan 2021Cincinnati, Ohio• Managed a team of 5 operators in manufacturing; built and managed a team of 14 scientists in R&D, responsible for generating 40%+ revenue for the PDS-PPT group • Developed a model allowing clients to accomplish multiple projects in one visit, improving client experience, increasing repeat business, raising the number of projects, and increasing revenues• Created/instituted a central documentation, science, & technology database serving a 23-site network• Designed /managed development of technical developments/modifications, including a non-metallic disc and baffles for coating pans to improve coating efficiency and uniformity, saving time and cost• Collaborated on site improvement initiatives (PPI projects) to identify gaps/implement solutions• Developed, scaled up, validated, and commercialized multiple formulations (tablets, capsules, solutions, and so on), including abuse-deterrent formulations for controlled substances• Provided product promptly for clinical trials in humans, by applying enteric coating on HPMC capsules, for trials of a gastric acid-sensitive molecule • Successfully developed, produced, and commercialized IR tablets, capsules, osmotic tablets, minitablets, multiunit particulate systems, dry powder suspension for constitutions, orally disintegrating/chewable tablets, liquid oral suspension, and liquid gastro-retentive tablets • Authored several protocols, development reports, BPRs, Master Records, Process Validation Protocols and reports, bioequivalence protocols, the scope of research in compliance with USFDA• Regularly wrote feasibility reports, business proposals, contract documents, scope of work, change of scope documents, expansion of client/product specific areas for clients and business management -
Scientist IiiPatheon Dec 2012 - Jun 2016
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Senior ScientistPatheon Pharmaceuticals Sep 2008 - Dec 2012Formulation - Process Development, Scale up, Technology Transfer
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Senior Scientist/ManagerAptuit Jan 2008 - Aug 2008• Managed new drug product development team of 3 scientists/4 technicians developing small molecules, generic products, new drug product development (IR, SR Tablets, Capsules)• Led initiative to scale-up processes and transferred to a commercial facility• Managed pre-formulation and formulation work for an NCE, based on the expected product profile• Authored/reviewed batch records, protocols, reports, project feasibility & strategic plan documents• Prepared project proposals, authored scopes of work, feasibility reports, change of scope documents for projects with proposed scope and plan of product development work• Solved and resolved process-related issues on small and large-scale batch processes• Authored SOPs for Manufacturing, QA, QC Departments, preparing responses for audit findings -
Formulation ScientistInterpharm Inc Nov 2006 - Dec 2007Brookhaven, New York, United States• Managed generic product development and manufacturing projects at CDMO facilities by negotiating terms of agreement for specific projects, managed change of scopes to minimize impact on financial aspects of project and overall timelines.• Provided support for commercial scale manufacturing at CDMOs and improved production processes to maximize yields• Evaluation of CDMO facilities for allotment of projects to ensure success and establish long term business relations• Successfully developed generic prescription product for proton pump inhibitor. • Research scale processes were successfully transferred to manufacture pilot scale and commercial batches at CDMO. • Managed scale-up & technology transfer of IR tablet manufactured by high shear granulation• Helped organization to build its own formulation development laboratory to initiate product development internally up to formula development to reduce cost of product development. • Based on requirements, procured and installed encapsulation machine, tablet press, and bottom spray equipment in research facility.• Trained technicians to work in formulation development laboratory to support formulation scientists • Trouble shooting of problems encountered in large scale production processes • Authored batch records, protocols, development reports and submission documents (CMC sections) -
Senior Research OfficerGlenmark Pharmaceuticals Nov 2002 - Oct 2006• Helped organization develop formulation development lab by negotiating user requirements on new and used equipment, procuring multi-functional small scale equipment, authored SOPs, trained technicians on running equipment and documentation practices in GMP and Non-GMP areas.• Initiated documentation practices and procedures for formulation R&D, intermediate scale manufacturing suite, material sourcing and dispensing, and record keeping. • Successfully transferred the pilot scale productions to commercial scale batches.• Supported procurement of & IQ, OQ, PQ initiatives for equipment and technology in research and development, pilot scale and commercial facilities • Developed liquid, semisolid, and solid oral formulations for clinical trials in animals and humans• Successfully developed a non-infringing strategy for PARA IV product, and other ANDAs including designing of bioequivalence protocols, evaluation of bio-equivalence data• Rewarded for development of NDA product for phase three clinical trials.• Formulated and Developed several ANDA products (enteric release product, sustained release product based on functional coated pellets, pellets compressed into tablets, matrix release tablets, IR tablets & capsules, semisolid products, dry powder suspension for reconstitution)• Performed trouble shooting for problems encountered in large scale production processes • Authored protocols, development reports, batch records, submission documents (CMC Section) -
Quality Assurance OfficerSun Pharmaceuticals Sep 2001 - Nov 2002• Performed IQ, OQ, PQ of various equipment’s installed into commercial and pilot plant facilities• Drafted and reviewed batch records, deviation reports, SOPs, qualification, validation protocols• Performed Process validation: Prospective and Retrospective, In-process & finished product checks• Participated in internal compliance audits with respect to cGMP norms• Successfully implemented new stability sample retention system for existing and new products• Implemented new formats of batch records by providing training in phase• Rewarded with promotion in less than six months because of impressive performance
Y C Education Details
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Symbiosis InstituteBusiness Administration (Business Management) -
3.85
Frequently Asked Questions about Y C
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Y C works for Fda
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Y C's current role is Reviewer and Staff Fellow OPQ, OPMA CDER.
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Y C attended Uc James Winkle College Of Pharmacy, University Of Cincinnati College Of Business, Symbiosis Institute, Nagpur University, Savitribai Phule Pune University.
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Y C's colleagues are Patsy Benefield, Gaurang Joshi, Taylor Bostic, Mph, Karin Knudson, Emilios Andrew Papanastasiou, Mable Dixon, Janae Price.
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