Eric Lin

- Providing strategic and tactical direction for the external development of injectables, inhalation, topical products etc. - Assisting Business Development and Portfolio Management in assessing new opportunities for internal development, co-development, 505b(2) products, licensing, and acquisitions. - Conducting scientific literature search, evaluates, develops, and recommends new platform technologies, suggesting patentable, patent non-infringing and design around technologies for First to File products. - Performing Due Diligence for new product pipeline and feasibility analysis for external development. - Designing experimental plans or oversee them, and ensure routine development and scale-ups, process validation, including trouble shooting. - Overseeing Product Development Reports, process development reports and other relevant documents as required for filing. - Technical support in combination products, complex long acting injectables, dry powder inhaler, metered dose inhaler, and Design History File (DHF). - Subject matter expert in working cell bank, upstream and downstream process for peptide drug substance using recombinant DNA technology, and essential performance testing for injection devices. - Monitoring commercial batch manufacturing for key injectable products and providing technical inputs for process troubleshooting and investigation. - Providing inputs for project budget, working with finance for rolling forecast of 3+9 and 5 years project spend, and reviewing third party proposals and costs.

• Lead all product development activities for developing formulations to successful ANDA filing and approval. • Responsible for the planning and development of various pharmaceutical dosage forms such as generic sterile injectables, lyophilization drugs, suspension, emulsion, etc. through Quality by Design (QbD) approach. • Experience in pharmaceutical and combination products; review and support DHF with device suppliers. • Write/ review protocols, batch records, and Tech Transfer Report to carry out process development and evaluation work, scale up and pivotal batch manufacturing for ANDA submissions. • Coordinate the manufacturing of engineering/exhibit batches at contract manufacturing organization (CMO) sites. • Provide guidance and supervise the project progress with contracted development manufacturing organization (CDMO). • Perform technology transfer from laboratory scale to the production scale. • Conduct stability study as per ICH guidelines. • Coordinate sourcing of API’s, excipients, packaging components for new products to meet regulatory requirements. • Prepare/review specifications for drug products and packaging components. • Direct and monitor the Development, Scale-up, Exhibit, Technology Transfer, Validation and Product Launch activities. • Review Risk Analysis, Product Development Reports, Chemistry & Manufacturing Control Sections, QbR, Exhibit Batch Manufacturing Records, Change control justifications and SOPs.

• Established a new 11,000 sq ft GMP laboratory and led Formulation Development team / process development & analytical development for development of bioequivalent, stable and scalable formulations through Quality by Design (QbD) approach. • Design and supervise execution of formulation trials which involve semi-solid, liquid, and solid oral dosage forms and evaluate stability data to finalize formulation composition. • Develop manufacturing processes for R&D formulations so that the technical transfer is successful. • Coordinate sourcing of API’s, excipients, packaging components for new products to meet regulatory requirements. • Coordinate with Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control, etc., to expedite the development and approval of new products by FDA. • Prepare/review specifications for drug products and packaging components • Coordinate the manufacturing of exhibit/submission batches per regulatory requirements • Reviewing prototype formulation development documents, Risk Analysis, Development Reports, Exhibit batch Protocols, Chemistry & Manufacturing Control Sections, QbR, Exhibit Batch Manufacturing Records, Change control justifications and SOPs • Monitoring of Development, Scale-up, Exhibit, Technology Transfer and Validation activities • Coordinate with Clinical Research Organizations for performing Bioequivalence studies & ensure positive track record of Pivotal studies for successful filings.

- Supervising formulation scientists and technicians for daily activities. - Developing solid dosage forms of controlled-release and immediate-release therapeutics for generic drug formulations. - Developing semi-solid forms of formulations. - Sourcing active pharmaceutical ingredients. - Literature search and patent evaluation for not-infringed formulation. - Supervising and monitoring the execution of experimental, scale-up product development, technical transfer and submission batches for stability and clinical studies. - Review Product Development Report, Batch Record, and SOP (Standard operation procedures) documentations. - Managing projects and coordinating with QA, RA, and Analytical lab personnel to schedule development activities and meet project deadlines. - Review bio study protocols and coordinating with bio lab for all bio study activities.

- Supervising formulators, technicians, and technical writer for daily activities. - Developing solid dosage forms of controlled-release and immediate-release therapeutics for generic drug formulations. - Literature search and patent evaluation for not-infringed formulation. - Supervising and monitoring the execution of experimental, scale-up product development, technical transfer and submission batches for stability and clinical studies. - Preparing Product Development Report, Batch Record, and SOP (Standard operation procedures) documentations. - Managing projects and coordinating with QA, RA, and Analytical lab personnel to schedule development activities and meet project deadlines. - Supervising and coordinating with contracted lab for formulation development.

- Developing solid dosage forms of controlled-release and immediate-release therapeutics for generic drug formulations. - Literature search and patent evaluation for not-infringed formulation. - Conducting experimental, scale-up pilot, and pivotal batches for stability and clinical studies. - Preparing documentation such as Formulation Proposal, Process Development Report, Process Characterization Protocol, and Product Development Report. - Managing projects and coordinating with QA, RA, and Analytical lab personnel to schedule development activities.