Director

• Responsible for Structure Therapeutics’ small molecule Technical Operations projects in terms of the development of drug substances
• Support late-stage drug substance activities in contract development and manufacturing organizations (CDMOs)
• Focus on late stage and commercialization readiness
• Manage all interactions with CRO’s or CDMOs to ensure delivery of high-quality results and reports in time to meet regulatory requirements, including GxPs
• Accountable for the delivery of proper documents for regulatory filings
• Develop robust and scalable synthetic routes suitable for commercialization
• Direct CRO teams to perform experiments to define process parameters intended to develop suitable processes for chemical manufacturing and commercialization
• Monitor the progress of projects and provide technical solutions to CRO and CDMOs

Associate Director – Director of Drug Substance

• Responsible for audits within the APAC region.
• Ensuring audit objectives and scopes are risk based in alignment with the audit strategy.
• Coordinate and oversee audits performed by contracted auditors.
• This involves scheduling audits, selecting resources, reviewing reports, etc.
• Execution of the audit (remote or on site) as the lead auditor when the audit is not contracted.
• Ensure audit documentation and audit quality management system is completed according to procedures and established timelines.
• Act as a liaison to internal BioNTech stakeholders through all phases of the audit.
• Ensure that newly identified risks are considered for the audit strategy.
• Support development of a robust CAPA (Corrective and Preventative Action) Plan and approve the CAPA plan.
• Track CAPA and effectiveness checks to completion.

Associate Director, Audit & Inspection Management

• Work directly with the Founder to drive China market entry - from early strategy to hands-on execution
• Build and execute initial hiring plans - source, engage, and close high-caliber talent
• Support fundraising efforts - prepare materials, coordinate investor conversations, and follow through
• Help establish A1’s presence in China - including office setup, vendors, and operating structure
• Drive external positioning - support PR, partnerships, and key relationships
• Turn ambiguous ideas into clear plans, and ensure they get executed
• Act as a central operator across teams - tracking priorities, resolving bottlenecks, and pushing progress
• Handle high-urgency, unstructured problems with speed and sound judgment

Director, Founder's Office

• Agent and vendor management
• Manage and evaluate all agents and vendors of COL
• Oversee contracts with third-party service providers
• Ensure COL manual complies with international shipping laws
• Manage claims and insurance management
• Responsible for the framework and operational oversight of COL Bills of Lading and Sea waybills
• Monitor compliance with corporate governance policies

Managing Director – Cloud Ocean Line

• Be responsible for ensuring optimal development of China biomarker testing strategy aligned with global strategy.
• Identify scientific gaps or a specific tailored biomarker strategy relevant for China for a certain asset.
• Oversee the general execution of China biomarker testing in clinical studies and provide guidance and leadership in troubleshooting when applicable.
• Be responsible for overseeing the PDx development strategy/execution in China.
• Be responsible for driving local biomarker research projects in China.
• Collaborate effectively with an integrated organizational framework across translational medicine, biomarker and R&D (in China and globally).
• Coordinate the China biomarker/precision medicine sub-teams for specific diagnostic products or indications to enhance the value of the assets through incorporation of diagnostic biomarkers into exploratory, clinical, regulatory, and Medical/Commercial strategies.
• Form alliances across scientific disciplines and participate in the decision-making process that typically require developing new options to solve highly complex problems for the completion of team goals.
• Provide internal and external subject matter expertise for BMS Precision Medicine activities in China.
• Expand and strengthen external networks through collaboration with external partner/vendor, interaction with local HA, interaction with industry association and academic institutes in China.
• Acquire and disseminates precision medicine knowledge for organizational learning and capability in China.

Director, China Precision Medicine Lead

• Provide project overarching analytical support within the China organization
• Serve as a local interface for all clinical and commercial CMC project teams with Chinese collaboration partners, CDMOs, and vendors
• Engage directly with local collaboration partners, CDMOs, vendors, etc. to facilitate analytical transfers and support quality control for mAb and ADC projects
• Support operational & troubleshooting activities on-site
• Review project documentation, including method development reports, analytical procedure protocols, method qualification/validation reports, according to regulatory guidelines
• Independently drive assigned analytical packages within global technical operations
• Ensure translation of technical documents for analytical transfer activities
• Organization of technical visits at collaboration partners, CDMOs or vendors
• Subject matter expert support for internal audits and Health Authority inspections

See all jobs on JobTailor

Associate Director – Director of Drug Substance

Associate Director, Audit & Inspection Management

Director, Founder's Office

Managing Director – Cloud Ocean Line

Director, China Precision Medicine Lead

Director AS&T, mAb & ADC Network