Ganeshkumar Subramanian Ms, Mba Email & Phone Number

New Brunswick, New Jersey, United States

Responsibility for Robustness and Continued Process Verification function across small molecules drug substance, drug product, and packaging, a critical role that supports uninterrupted product supply to our patients. Provide leadership and strategy collaborating across MS&T organizations, internal & external manufacturing, and IT in evolving the collection, analysis, and reporting of manufacturing robustness metrics. Drive the evolution of the robustness program to focus on proactive actions that improve product robustness and reporting on all metrics that are indicators of manufacturing health.

New Brunswick, Nj, Usa

Responsible for a major CMO that manufactures and package multiple large volume solid oral dosage products. Accountable for technology transfer of products, packaging etc., from one site to another ensuring robust technical transfer within budget constraints. Review and approve Technology Transfer plans, Validation Master Plans, Process risk assessments etc. Lead investigation of a quality event or manufacturing deviation, provide assessment on impact to product quality. Review change controls, APQRs, regulatory filing and annual reports. Represent Manufacturing Technology on project teams working closely with QA, Supply Chain, Procurement and SRMs in cross functional matrix team to develop strategies, implement OPEX initiatives, evaluate scale-up and yield improvement opportunities, and ensure compliance and security of supply. Support CMO selection process – compilation of technical packages, due diligence, rating. Support operational management of CMO as per SRM governance structure.Product robustness - technical lead for creation of process robustness monitoring plan, process control strategy, and provide technical oversight of TPM sites to ensure continuous process monitoring for all products in scope. Manage regulatory filing updates of manufacturing information, as required.

New Brunswick, Nj

Drug product development team lead, with responsibility for delivering formulation, generating stability data and proposing specification. Executed formulation development work at CRO on abbreviated timelines, starting with request for proposal (RFP) through transfer of product, process and documentation.Developed a low drug load wet granulation based tablet formulation for DSE, ADME and food effect studies in an accelerated timeline (6 months). This involved formulation screening, stability studies on multiple prototypes, and optimizing manufacturing process. Key member in the development and commercialization of a FDC anti-retro viral tablet jointly developed with another MNC. Working knowledge of alternate drug delivery approaches like liquid filled capsules, soft-gel capsules, and semi-solids products. Wrote proposals for independent research, mentored summer interns on projects using compaction simulator, instrumented die (helped design a die with multiple pressure sensors) and Pyrobuttons® that resulted in developing work flow process for bi-layer tablet feasibility assessment and optimizing coating process for a moisture sensitive compound.Nominated to lead or represent department in multiple limited duration initiatives such as; Process scale-up optimization, Enabling CSO - Kaizen project, Aegis - data collection, handling and standardization, Product risk assessment process review and strategic initiative, to list a few.

New Brunswick, Nj

Formulation development, scale-up and Tech Transfer of solid dosage forms.

New Brunswick, Nj

Formualtion development of early and late stage NCEs.

Cuddalore Area, India

•Managed production for a 3000 tons/yr Pentaerythritol manufacturing plant supervising 15 employees across various unit operations.•Monitored unit-operations like distillation, evaporation, batch and continuous crystallization, batch and continuous filtration, separation and drying.•Acquired valuable trouble shooting skills and suggested methods to de-bottleneck critical processes, reduce waste generation and improve waste recovery.

Master Of Business Administration - Mba, Gpa 3.9

Completed Executive MBA with courses in Strategy, Marketing, Finance, Entrepreneurship and Lean Six Sigma.

Masters, Chemical Engineering

Activities and Societies: WVU student Chemical Engineering chapter. AICHE Student Member

Bachelor Of Technology (B.Tech.), Chemical Engineering