台灣微脂體股份有限公司

Essential Duties and Responsibilities: Your primary focus will be serving as a valuable business enabler, overseeing contract reviews and providing legal advice to facilitate the company's rapid growth. We are flexible to consider more senior roles depending on candidate qualifications. 1.. Review, draft and negotiate related contracts with sales, procurement, NDA, distribution, maintenance, logistics, and a variety of other business transactions. 2.. Document and system management, including but not limited to internal control practice issue spotting, contract control and filing. 3.. Provide accurate and timely counsel in a variety of legal topics. 4.. Identify, research, develop, and analyze company policies, regulatory change, compliance requirements, and general legal and risk management issues. 5.. Conducting legal research and due diligence. 6.. Communicate and negotiate with external parties on all legal matters. 7.. Assist to prepare board agenda and general meeting. 8.. Assist stock transfer affairs and shareholder communication.

Essential Duties and Responsibilities: Responsible for study design and study plan of analytical development and related tasks. To perform a wide range of analytical tasks from complex generics and new drug development phase, submission package and deficiency letter response. The work is critical to advancing our lipid-based delivery system, complex generics and new drug development to a commercial stage. We are flexible to consider more senior roles depending on candidate qualifications. 1.. Analytical Method Development and Validation: - Plan and execute the development and validation of analytical methods for raw materials, drug substances, in-process controls, intermediates, and drug products. - Contribute to analytical method optimization, problem-solving, and technical transfer specifically for liposomal drug products and drug substances. - Ensure accuracy, precision, specificity, and robustness of developed methods. 2.. Experimental Design and Execution: - Plan and perform experiments to test new or existing theories. - Investigate potential business opportunities through research into new products or production methods. 3.. Data Analysis and Technical Reporting: - Review and analyze data to support scientific research efforts. - Address analytical deviations that may impact test results. - Author method validation protocols and execute validation studies, preparing necessary reports. - Communicate results to supervisors and other scientists. 4.. Project Management: - Develop and manage project timelines, coordinate cross-functional teams, and ensure timely execution while mitigating risks. - Collaborate closely with CMOs to align production schedules, monitor key milestones, and ensure compliance with GMP regulations. - Facilitate the transfer of internal technical documents, ensuring seamless collaboration between R&D, quality, and regulatory teams.

Essential Duties and Responsibilities: The (Associate) Manager, CMO & Project Management serves as the crucial liaison between the CMC division and CMOs, facilitating project coordination and communication among key stakeholders. This role collaborates closely with internal Project Leaders, CMC functional teams (Technical Transfer, Process and Analytical Development, and QA), and CMO/Partners to realize corporate objectives. The primary focus is on supporting projects across various phases at CMOs, encompassing technical transfer, clinical trial material supply, registration activities, and eventual commercial supply, while overseeing schedules and budgets. We are flexible to consider more junior or senior roles depending on candidate qualifications. 1.. Manage CMOs to develop and drive timelines from technology transfer to GMP batch manufacturing for clinical supply, registration use, and commercial supply. 2.. Communicate with internal project team members and external CMOs via email, phone calls, meetings, or in person to discuss issues, milestone prerequisites, and project progress. 3.. Evaluate and recommend suitable CMOs per project development phase through due diligence, assessing investment requirements, and providing operational input into agreements. 4.. Facilitate and handle warehouse storage, logistics, labeling, and packaging activities on a monthly basis per project. 5.. Identify risks and develop mitigation strategies to meet project timelines and collaborate with senior managers. 6.. Align project timelines, budgets, activities, and direction to achieve corporate objectives within the CMC Division. 7.. Negotiate contracts with CMOs (in collaboration with BD), prepare and monitor purchase orders, and track invoices according to project progress. 8.. Work with the business development team and external partners for commercial supply mapping. 9.. Complete tasks as assigned by the supervisor.

We are seeking a Project Coordinator to join our Clinical Team. This role will be responsible for providing administrative and logistical support to ensure the efficient and effective management of clinical projects. 1.. Assist in the creation, updating, and organization of various clinical trial documents and contracts, while maintaining the ERP system. 2.. Collaborate closely with the clinical research team to ensure research activities and execution align with company objectives. 3.. Support the procurement, tracking, and management of clinical research equipment and supplies, providing logistical assistance for supplier supervision tasks. 4.. Work alongside the finance team to coordinate project budgets, manage payments, track invoices, and handle reimbursement-related responsibilities. 5.. Facilitate communication by coordinating and arranging meetings for internal project teams and external partners. This includes drafting meeting minutes and managing administrative tasks related to project resources. 6.. Perform other tasks as assigned by supervisors.