Sr. Manager Product Development - Arrotex Services India LLP - Pune, Maharashtra, India
(2024-04)
Manager Product Development - Arrotex Services India LLP - Pune, Maharashtra, India
(2021-04 - 2024-03)
Formulation and Development/Technology transfer: Responsibilities encompassed providing technical leadership and expertise across all stages of product development, technical transfer, and life cycle management. This included leading cross-functional teams, ensuring regulatory compliance, and driving operational excellence within a GMP and QMS framework. The role required proactive problem-solving, effective communication with internal and external stakeholders, and a commitment to delivering high-quality results.
- Spearheaded technical support and guidance in product development, technical transfer, and life cycle management, successfully launching new products across global markets including ANZ, South Africa, EU, and Asia Pacific.
- Formulated and implemented robust and cost-effective development strategies, encompassing critical aspects such as manufacturing formulas, processes, patent restrictions, and analytical methodologies.
- Led product and CMO operations due diligence, providing expert technical input and direction for operations improvement, new product development, and line extension projects.
- Provided expert guidance and support to CMOs on cGMP expectations for development and manufacturing validation, ensuring timely execution and comprehensive review of all validation documents.
- Proactively identified and resolved complex technical problems faced by CMOs, providing effective solutions and consistent technical support.
- Instrumental in preparing comprehensive CMC technical documentation for regulatory registration files, ensuring compliance for both cosmetics and medicinal products.
- Fostered seamless collaboration and communication with cross-functional teams, including Supply Chain, Marketing, and Quality Assurance, effectively resolving product technical issues and promoting a unified approach.
- Provided strategic technical leadership and support to External Manufacturing Directors, consistently exceeding service delivery expectations and ensuring client satisfaction.
- Served as a subject matter expert, supporting Regulatory Affairs in all technical aspects of product registration, including the preparation and thorough review of eCTDs and technical files to meet stringent regulatory standards.
- Efficiently coordinated responses to technical queries from regulatory agencies, clearly articulating complex technical information and ensuring timely and accurate communication.
- Led technical investigations of annual stability Out of Specification (OOS) investigations, expertly identifying root causes, implementing corrective actions, and ensuring product quality and stability.
- Proactively identified and mitigated technical risks associated with new product development (NPD) projects, implementing robust mitigation strategies to minimize potential roadblocks.
- Excelled as a key member of multi-functional NPD project teams, demonstrating effective project management skills and consistently delivering on project objectives within ambitious timelines.
- Successfully led technical transfers of products to CMOs, diligently managing timelines and ensuring the delivery of high-quality, fit-for-purpose products that meet stringent specifications.
- Proactively reviewed and updated local Technical SOPs, ensuring adherence to current standards and fostering a culture of continuous improvement within the technical operations team.
Sr. Associate Product Development - Arrotex Services India LLP - Pune, Maharashtra, India
(2020-03 - 2021-03)
Sr. Associate Product Development - Generic partners Pvt Ltd - Pune, Maharashtra, India
(2015-09 - 2020-02)
Formulation and Development/Technology transfer: Responsibilities encompassed providing technical leadership and expertise across all stages of product development, technical transfer, and life cycle management. This included leading cross-functional teams, ensuring regulatory compliance, and driving operational excellence within a GMP and QMS framework. The role required proactive problem-solving, effective communication with internal and external stakeholders, and a commitment to delivering high-quality results.
- Spearheaded technical support and guidance in product development, technical transfer, and life cycle management, successfully launching new products across global markets including ANZ, South Africa, EU, and Asia Pacific.
- Formulated and implemented robust and cost-effective development strategies, encompassing critical aspects such as manufacturing formulas, processes, patent restrictions, and analytical methodologies.
- Led product and CMO operations due diligence, providing expert technical input and direction for operations improvement, new product development, and line extension projects.
- Provided expert guidance and support to CMOs on cGMP expectations for development and manufacturing validation, ensuring timely execution and comprehensive review of all validation documents.
- Proactively identified and resolved complex technical problems faced by CMOs, providing effective solutions and consistent technical support.
- Instrumental in preparing comprehensive CMC technical documentation for regulatory registration files, ensuring compliance for both cosmetics and medicinal products.
- Fostered seamless collaboration and communication with cross-functional teams, including Supply Chain, Marketing, and Quality Assurance, effectively resolving product technical issues and promoting a unified approach.
- Provided strategic technical leadership and support to External Manufacturing Directors, consistently exceeding service delivery expectations and ensuring client satisfaction.
- Served as a subject matter expert, supporting Regulatory Affairs in all technical aspects of product registration, including the preparation and thorough review of eCTDs and technical files to meet stringent regulatory standards.
- Efficiently coordinated responses to technical queries from regulatory agencies, clearly articulating complex technical information and ensuring timely and accurate communication.
- Led technical investigations of annual stability Out of Specification (OOS) investigations, expertly identifying root causes, implementing corrective actions, and ensuring product quality and stability.
- Proactively identified and mitigated technical risks associated with new product development (NPD) projects, implementing robust mitigation strategies to minimize potential roadblocks.
- Excelled as a key member of multi-functional NPD project teams, demonstrating effective project management skills and consistently delivering on project objectives within ambitious timelines.
- Successfully led technical transfers of products to CMOs, diligently managing timelines and ensuring the delivery of high-quality, fit-for-purpose products that meet stringent specifications.
- Proactively reviewed and updated local Technical SOPs, ensuring adherence to current standards and fostering a culture of continuous improvement within the technical operations team.
Research Scientist - Emcure Pharmaceuticals Ltd - Pune, Maharashtra, India
(2007-06 - 2015-09)
As a Research Scientist, responsibilities encompassed all aspects of formulation development, from initial research and development to technology transfer and commercialization. This included conducting literature reviews, designing and executing experiments, collaborating with cross-functional teams, ensuring regulatory compliance, and troubleshooting manufacturing issues. The role required a strong understanding of pharmaceutical sciences, analytical techniques, and GMP regulations, as well as excellent problem-solving, communication, and teamwork skills.
- Conducted comprehensive literature reviews, patent studies, preformulation, and stability studies, generating essential data to support new product development initiatives.
- Led formulation and development efforts, effectively employing Design of Experiments (DOE) and Quality by Design (QbD) methodologies to optimize formulations and ensure robust product performance.
- Facilitated seamless cross-functional collaboration between R&D and other critical departments, including Production, Quality Assurance, Quality Control, and Warehouse, ensuring efficient technology transfer and product launch.
- Played a key role in determining and finalizing batch sizes, considering critical factors such as recommendations from the transferring site and equipment availability at the receiving site.
- Coordinated and oversaw all aspects of bioequivalence studies for new products, including budgeting, scheduling, comprehensive evaluation of study results, and rigorous tracking of CRO performance to ensure adherence to timelines and quality standards.
- Provided essential technical assistance in the preparation of critical regulatory documents, including BMR, BPR, and validation protocols, ensuring compliance with regulatory requirements.
- Collaborated effectively with the regulatory department, providing necessary support and documentation to expedite the completion and submission of regulatory documents.
- Meticulously maintained comprehensive documentation, including detailed lab notebooks, development reports, and engineering standards, ensuring traceability, knowledge sharing, and robust data integrity to support process and formulation development efforts.
- Successfully monitored scale-up and commercial batches during technology transfer to production, ensuring smooth transition and consistent product quality during large-scale manufacturing.
- Developed and implemented standard operating procedures (SOPs) to standardize processes, enhance operational efficiency, and ensure consistent adherence to best practices.
- Proactively conducted process troubleshooting and investigations to address OOS (Out of Specification) and OOT (Out of Trend) events, identifying root causes and implementing corrective actions to maintain product quality and process control.
- Provided valuable support to plant QA in various critical activities, including process optimization, validations, and other quality-related initiatives, contributing to the overall efficiency and effectiveness of quality systems.
Research Associate II - Aurobindo Pharma Research Center - Mumbai, Maharashtra, India
(2006-05 - 2007-05)
Responsibilities involved actively contributing to the formulation and development processes of solid oral dosage forms, with a specific focus on meeting the stringent requirements of the US pharmaceutical market.
- Provided vital assistance in the formulation and development of solid oral dosage forms specifically designed for the US market, ensuring adherence to stringent regulatory standards and industry best practices.
Trainee Research Associate - Unichem Laboratories - Goa, India
(2006-01 - 2006-05)
Responsibilities involved active participation in a comprehensive training program focused on pharmaceutical formulation and development, gaining practical experience and knowledge in key processes, equipment utilization, and excipient properties, with a specific focus on solid dosage form development.
- Gained comprehensive training in key formulation and development processes, encompassing critical stages, equipment operation, and excipient properties, developing a solid foundation in pharmaceutical development.
- Acquired essential skills and knowledge in the development of solid dosage forms, demonstrating proficiency in fundamental techniques and best practices.
