Careers

• Participate and contribute to the implementation of strategies and timelines to ensure a successful clinical or commercial product launch, including oversight of CMOs, manufacturing strategy, priority, and forecasting activities that impact overall drug requirements.
• Roll out serialization for commercial manufacturing to meet requirements and product traceability. Interface with SC, CMC, AD, RD, Quality Assurance, Procurement, PMO teams, etc. to ensure timely implementation of the requirements.
• Overview of the manufacturing activities and well-planned for all products. Manage the technical transfer to CMOs, manufacturing drugs for the demand of clinical and commercialization.
• Having excellent troubleshooting on any issues for completion/accuracy of the product timeline. CMO management globally including common and emergency productions of DSI/DS/DP for target timeline.
• Interact with cross-functional departments to provide the required information or move forward with the projects.
• Project management including normal and emergency production of DSI/DS/DP. Manage the equipment maintenance and purchasing the necessary materials.
• Budget management including payment and invoice management of all CMOs.
• To complete the assignment by supervisor.

• Manage contract manufacturing organization related activities, project management, daily communication and meeting with vendors, PR/PO/Contract activities, equipment maintenance, material purchasing, and provide product information and communication between OBI and foreign & domestic CMO.
• Assist with vendor selection perform vendor search, due diligence, facility inspection, and vendor evaluation.
• Supply management closely with other teams to ensure the production supply suffices for development study and clinical trial requirements and is delivered promptly.
• Manage technical transfer to contract manufacturing organizations assist R&D in transferring technical information to the CMO.
• Budget control, including payment and invoice management, ensure the payment on time, and clarify the issue of finance. To be familiar with the ERP system.
• Troubleshooting the issues in manufacturing activities, actively reflecting on the issue to the supervisor, and solving them promptly.
• To complete the assignment by the supervisor.

• Participate and contribute to the implementation of strategies and timelines to
ensure a successful clinical or commercial product launch, including oversight of
3PL/4PL, supply strategy, priority, and forecasting activities that impact overall
drug requirements.
• Roll out serialization for commercial manufacturing to meet requirements and
implementation of strategies and timelines to
implementation of strategies and timelines to
ensure a successful clinical or commercial product launch, including oversight of
3PL/4PL, supply strategy, priority, and forecasting activities that impact overall
drug requirements.
• Roll out serialization for commercial manufacturing to meet requirements and
product traceability. Interface with CDMO, PMO, 3PL/4PL, Quality Assurance,
Regulatory Affairs, BioStats, Clinical teams, etc. to ensure timely implementation
of the requirements.
• In partnership with CDMO teams, develop and implement secondary and tertiary
packaging solutions as well as shipping and transport qualifications in accordance
with applicable regulations.
• Working with 3PL/4PL, Distribution, Marketing, and Sales Partners, ordering and
supplying drugs for the sites/CRO. Manage inventory of finished drug products.
• Having excellent troubleshooting on any issues for completion/accuracy of the
product timeline. Logistics management globally including common and
emergency shipments of DSI/DS/DP/IP, and IRT system review for accuracy.
• Develop commercial/clinical supply chain business processes, templates, and SOPs. Serve as a clinical supply subject matter expert for regulatory inspections. Contribute to INDs, NDAs, and other regulatory documents as needed.
• Manage evaluation/selection/implementation/oversight of packaging, and labeling operations, development and management of distribution or supply agreements, interfacing between the CDMO and Clinical teams to ensure smooth conduct of clinical studies, coordination of import and export, etc.
• To complete the assignment by supervisor.

• Assess risk in internal controls.
• formulate the annual audit plan according to the risk assessment results and the mandatory requirements of laws and regulations.
• Review self-inspection reports prepared by all departments and subsidiaries and submit self-assessment reports along with reports on the correction of defects and irregularities in internal control systems discovered by the internal audit departments.
• Review audit reports submitted by each subsidiary and follow up on the correction of any defects and irregularities in internal control systems.
• Execute the approved annual audit plan, including specific tasks or plans required by the management, the board of directors and the audit committee.
• Follow-up audit findings and corrective actions.
• Prepare the data and ask for Finance Department’s help to report on Market Observation Post System (公開資訊觀測站) according to mandatory requirements of laws and regulations on Jan., Feb., Mar., May, Dec.
• Provide advice on improving operational process efficiency and consulting services on the design of internal control systems.
• Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications and content, and participating in professional societies.
• Report audit findings to the Chairman and the Board, providing insights on area of strength and improvement.
• The job title and salary will be adjusted based on experience.

• Handle accounting, maintain accounting documents and records.
• Preparation of consolidated financial statements
• Serve as the contact window for accountants and assist in account checking.
• Provide support and advice on management accounting.
• Assist in tax declaration matters such as income tax.
• Annual budget consolidation
• Supervision of subsidiaries
• Other tasks assigned by the supervisor.

• Work closely with clinical trial centers and KOLs locally and overseas to ensure proper clinical trial designs and conduct for new drugs.
• Provide medical expertise in developing clinical programs in line with global strategies.
• Act as medical resources to the company and particularly to the Clinical Operations Department (protocol and CRF review, medical monitoring in clinical trials, including assessment of adverse events, local and global pharmacovigilance activities, discussions with investigators, and internal meetings)
• Develop clinical programs to support product registration and marketing.
• Assisted the senior management with strategic planning and decision-making.
• Support cGCP and regulatory requirements for international IND filings.
• Provide training to clinical and regulatory staff.

• Provides clinical direction and support to operational teams, including care coordination, disease management, clinical process re-design, and any programs yet to be developed.
• Monitors and assists in implementing a quality, cost-effective clinical program.
• Supports OBI's efforts in developing and communicating physician practice profiles.
• Develops and maintains critical provider and community collaborative relationships and ensures that all activities and processes support patient care, reduce unnecessary barriers, and optimize physician engagement.
• Assists in developing strategic plans for addressing quality and healthcare cost management concerns and opportunities.
• Responsible for recording/communicating progress.
• Needs to have some management experience, given that people in this role need to manage some reports.

• Execute animal experiments, including tumor cell expansion, harvest and implantation, monitoring tumor growth, collecting samples (blood, tumor, and organs, etc.) for further analyses.
• Conduct in vitro cell-base assays, such as proliferation, apoptosis, and cytotoxicity.
• Perform molecular biology and biochemistry experiments, such as flow cytometry, RT-PCR analysis, western blot, and ELISA.
• Work with and manage CROs to develop and refine existing protocols and to maintain or enhance support of internal programs.
• Real-time update experimental data to supervisors and team members.
• Routine laboratory notebook writing and progress preparation.
• Support regular laboratory maintenance.
• Perform other items requested by supervisors.

• Perform testing and report result for HPLC, capillary electrophoresis, spectrometer, or mass spectrometer and general analytical instruments.
• Execute method development, method qualification and participate in method transfer activities and tests of stability studies followed by supervisor’s guidance.
• Draft and perform equipment and method validation report with basic regulatory expectations for quality control strategies.
• Carrying out maintenance for laboratory equipment and environments.

• Independently plans, initiates, and executes synthetic organic chemistry experiments and interprets and communicates results as part of a multi-disciplinary team.
• Utilizing traditional synthetic chemical techniques, execute routine chemical procedures involving organic chemistry, HPLC, TLC and MS analysis of chemical compounds.
• Operate a variety of analytical instruments including HPLC, NMR to enable structural determination and purity assessment.
• Ability to foster teamwork and actively participate in the review of projects with colleagues throughout the organization.