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Manufacturing Manager
2 weeks ago
**Key responsibilities of this role include**:
- Key point of contact / interface with CDMOs / CROs, managing projects, spanning development and clinical manufacture in close collaboration with Yisheng Biopharma’s technical and functional leads (Drug Substance, Drug product, Analytical, Quality, Supply Chain, and others)
- Ability to work under mínimal guidance to manage multiple assignments and/or business processes.
- Build and maintain positive relationships with all Process Development and Operations functions to increase overall efficiency and success of programs.
- Supplier evaluation and outsourcing management including site selection activities.
- Develop scopes of work in close partnership with technical leads and cross functional leads
- Ensure projects and/or programs meet results, compliance, speed, quality, and cost.
- Budget management, including purchase orders, financial forecasting, and associated finance cycles for externalization, adhering to financial targets and systems.
- Establish and maintain external collaborations and monitor supplier performance to continuously improve efficiency and effectiveness of suppliers
- Identify project optimization opportunities (e.g., timeline, budget, technical completion)
- Present analyses and recommendations to Senior Management
- Occasional domestic and international travel to support project results
- Opportunity to lead external projects in areas beyond synthetic small molecule Drug Substance, including hybrid modalities, based on portfolio needs
**Basic Qualifications**:
- Master’s degree and 8 years of relevant industry experience, within a cGMP manufacturing environment Or
- Bachelor’s degree and 10 years of relevant industry experience, within a cGMP manufacturing environment
**Preferred Qualifications**:
- Advanced degree in Biological Science or chemical engineering
- Demonstrated understanding of drug development and commercialization for biologicals product, including raw material and starting material sourcing, drug substance manufacture, process development, process engineering, and process characterization
- 2+ years of experience working with domestic and international CDMOs/CROs
- 2+ years of cGMP, Regulatory/CMC, legal, quality requirements, and import/export policies
- Self-starter with a high-level of comfort with ambiguity and complexity and the ability to multi-task while consistently delivering quality results.
- Experienced team member of cross-functional and matrixed teams including effective writing, presentation, and interpersonal skills to address a broad scope of audiences.
- An eye for business, high-level critical thinking, and strong problem-solving skills with the ability to structure, pragmatically scope, and solve problems.
- Demonstrated quantitative skills including experience in business process development, continuous improvement, operational excellence, and performance management.
- Strong knowledge in the use of project management methodologies and tools, resource management practices and change management techniques
Office Address:
High Street South Corporate Tower 1, 19th Floor, Unit LZ 12 and 15, 9th Avenue, Corner 16th Street, Bonifacio Global City, Taguig, Philippines
WeChat: chenyouren003
Viber: +65 8821-3425
