 Leading and directing the development of API and drug product commercial processes as well as developing manufacturing strategy for the company in preparation for design and optimization of phase appropriate formulations for preclinical and clinical, preformulation expertise, manufacture, supply chain, packaging, process validation, and commercialization. Accountable for setting manufacturing strategy and the management of CMOs to ensure that products are developed and manufactured in compliance with all applicable regulations. Provide functional leadership of manufacturing strategy to support development of commercial manufacturing processes and registration and commercialization of Imbria’s product candidates. Develop effective and efficient working relationships with both internal and external partners. Develop supply chain strategies to reliably forecast and ensure consistent product supply, while optimizing COGs. Manage Contract Manufacturing Organizations (CMOs), contractors, consultants, suppliers, and all outsourced CMC activities.  Reviews Technical/Quality agreements to ensure that outsourced activities are conducted in compliance with cGMPs and exercise appropriate oversight of the activities. Participated in regulatory CMC strategy development, providing input and support for the compilation of regulatory submissions required for clinical trial and marketing applications. Responsible for authoring CMC sections of Regulatory submissions and regulatory approvals (e.g., IND, CTA, NDA, and MAA). Participated in and represented CMC in meetings with global regulatory agencies. Executed contracts with CROS/CMOs required to deliver projects on time and within established budgets. In-depth knowledge on MS project, and establishing timelines CMC, supply chain and clinical activities.

 Lead small molecule product development: Manage and primary interface to contract development and manufacturing organization (CDMO) in the areas of API synthesis, preformulation, new product manufacturing, testing, analytical method development, formulation and process development, method validation, registration batch planning and manufacturing. Act as a technical project lead for CMC related activities (drug substance, preformulation, drug product and analytical development), project plan and resource management, deliverables and timelines associated with the clinical trial material supply. Great expertise with all the pharmaceutical unit operations related to API and DP development. Provide subject matter expert (SME) opinions on all the clinical programs and commercial activities relating to tech transfers, troubleshooting process development, optimization etc. Propose validation plans and supply chain management logistics for successful clinical and commercial batch execution. Propose best strategies for successful execution of post approval changes. Provide feedback and work directly with cross functional teams for effective communication and strict timeline management. Budget proposition and projection needs for API and DP for preclinical and clinical programs. Proposed DP DOE design and budgetary needs for the process development. Provide expert guidance on change controls, deviations, and remedial actions for the existing and new projects. Successfully manufactured Phase 1 US IND submission and CTM manufacturing for phase 1 supplies for CNS focused small molecule for oncology indication. Successfully involved in process development (DoE, QbD etc.) for oral tablet and suspension programs for Lennox Gastaut syndrome from Phase II to III registration batches and CTM manufacturing Successfully developed scale up and process development for higher strengths for Phase I-IIA program (indication-Partial onset seizures).

 Successful design and execution of scale up and technology transfer for the clinical supply (Registration batches) for Phase III OLE study (NDA application) for Parkinsonism indication. Successful design, execution, and completion of pilot bio-clinical supplies for extended-release applications. Design and execution of ODT (Orally Disintegrating Tablet) for a project for neurological disorder. Successful implementation of preformulation and formulation activities to meet the exploratory biostudy to see the pharmacokinetics of fast dissolving buccal dosage form. Supported CRO function in drug development of NCE product. Successfully dealt with the cross functional teams in a timely fashion of review and execution of batch records, supported formulation and processes for successful execution and completion of the submission batches. Successful launch of the new product of epilepsy line product. Acted as R&D support function for scale up to commercial batches and worked on with process technology group for successful deliverables on time. Successful CMO collaboration for new technology line products- SMEDDS in soft gel capsule for low soluble molecule. Effectively communicate with internal and external project and functional teams, present alternate paths forward, identify and evaluate gaps and provide recommendations. Develop and apply novel scientific technologies including new delivery systems, Polymeric approaches and evaluation tools to solve challenging product issues and support development projects. Drafting technical documents, CMC product development reports, and overall summaries supporting the regulatory filing of the NDA and 505b (2) applications.

 Designed and executed projects dealing with NDA and 505 b (2) applications and complex specialty generic products. Performance and execution of manufacturing batch records in a timely manner. Full knowledge and implementation of quality by design (QBD) and cGMP regulation in execution of the MBR for new products. Good experience and knowledge of technologies related to solubility/ dissolution rate enhancement techniques like micronization, Spray dried dispersions, nanosization, amorphization, co-crystals, complexes and solid dispersions for screening and early phase pharmacology and toxicology formulations. Melt extrusion-amorphous dosage forms and stabilization. Enhancement of solubility, supersaturation kinetics and bioavailability surge to develop a better dosage form. Screening of polymers to establish a database for early phase formulation development. Hands on experience with the preformulation experimentation. Micro bulk and pH controlled ionic presentation for the development of solid dispersions for low water-soluble challenging molecules for phase 1 phase development and exploratory studies. Extensive hands-on experience with handling of Nano- 16- and 27-mm extruder. Performed scale up batches for proof of concept or exploratory studies. Design, conduct preformulation profiling, and provide delivery strategy and formulation approaches based on fundamental understanding of critical API attributes by using integrated in vitro tools. Participation in technology drive, leading to innovation and IP rights. Scientific evaluation and literature search to enhance the quality of products. Formulation development of abuse deterrent formulations of opioid drugs. Strong written and documentation skills, regulatory filing reports, patent writing and technical reports and presentations etc.