Hays | Chemistry, Manufacturing
18 hours ago
Your new company
Our client is a fast-growing healthcare biotech company that aims at discovering and developing innovative therapies to help address unmet medical needs.
Your new role
Based in Hong Kong and reporting to the Chief Executive Officer, responsible for all CMC-related activities:
- Develop and lead all CMC-related activities (peptide and small molecule) including process chemistry, drug substance, drug product, analytical, and formulation, from the lead optimisation phase through to clinical development and commercialisation.
- Manage drug substance and drug product manufacturing service providers and API supply chains to support clinical trial development.
- Author all CMC sections of regulatory filings including FDA, EMA and other national authorities to support the conduct of clinical trials.
- Act as subject-matter expert for non-clinical CMC to both preclinical and clinical development teams, interact with all internal and external stakeholders to support CMC needs.
- Ensure high-quality standards, develop SOPs, implement GMP compliance and QC/QA.
- Monitor progress and regularly report to the CEO and other senior management, as needed.
- Manage and monitor the CMC timelines and budget.
What you'll need to succeed
- Master's degree in a relevant discipline (e.g. Chemistry, Biochemistry, Biotechnology).
- 10+ years of relevant experience in the pharmaceutical/biotech industry.
- Experience in the development of small molecules and/or peptides.
- Wide breadth of knowledge in all aspects of CMC including process chemistry, drug substance, drug product, analytical, and formulation.
- Hands-on experience of managing multiple internal and external stakeholders (e.g. working with CMOs on managing drug substance and drug product development).
- Experiences with writing CMC sections for regulatory filings and knowledge of current regulations in the US (particularly with the FDA) and EU.
- Biotech/startup experience, comfortable working in a small and very dynamic team structure that partially acts remotely.
- Proficient use of MS Office (Word, Excel, PowerPoint).
- Fluent communication in English, both written and spoken.
What you need to do now
If you are interested in the above opportunity, please forward your latest resume to or contact Kristi at +852 2230 7904 for more information.
If this role isn't quite right for you but you are looking to explore new opportunities in the life science sector, please contact Kristi Pang for a confidential discussion about your options.
Seniority levelDirector
Employment typeFull-time
Job functionHealth Care Provider
IndustriesPharmaceutical Manufacturing
#J-18808-Ljbffr-
Hays | Tax Manager
7 days ago
hong kong, Hong Kong SAR China Hays Full timeTax Manager (HK+China Tax | HK Group | Up to 70k) Be among the first 25 applicants This range is provided by Hays. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Your new role Oversee and manage tax compliance and reporting for both Hong Kong and China operations. Ensure timely and accurate filing of...
-
Hays | Senior Fashion Designer
2 weeks ago
hong kong, Hong Kong SAR China Hays Full timeYour Company Our client is a renowned garment manufacturer based in Hong Kong, specialising in diverse clothing categories. With a strong reputation for quality and innovation, they have established themselves as a leader in the fashion industry. As part of their exciting business expansion, they are now seeking a talented and experienced Senior Product...
-
Senior Production Manager
3 weeks ago
Hong Kong, Central and Western District, Hong Kong SAR China Gemini Personnel Group Limited Full timeLeading a plastics manufacturing company in China, Gemini Personnel Group Limited is seeking an experienced Senior Production Manager to oversee the Shanghai factory's operational responsibilities. The role involves planning, directing, and managing daily operations, focusing on production output, product quality, and timely delivery.About UsGemini Personnel...
-
Shanghai Plant Operations Director
3 weeks ago
Hong Kong, Central and Western District, Hong Kong SAR China Gemini Personnel Group Limited Full timeJob DescriptionWe are seeking a highly experienced Shanghai Plant Operations Director to lead our plastics manufacturing factory in Shanghai. As a key member of our team, you will be responsible for overseeing all operational aspects of the factory, ensuring seamless production, quality control, and timely delivery.Responsibilities:Develop and implement...
-
General Manager, Shanghai
3 months ago
hong kong, Hong Kong SAR China Gemini Personnel Group Limited Full timeOur client, a plastics manufacturing company in China, is seeking a General Manager for their Shanghai factory. The role involves overseeing all operational responsibilities. Responsibilities: Plan, direct, and manage daily operations of the manufacturing plant, focusing on production output, product quality and timely delivery. Oversee the supply chain,...
-
hong kong, Hong Kong SAR China Yiğitoğlu Full time3 weeks ago Be among the first 25 applicants Direct message the job poster from Yiğitoğlu Yiğitoğlu Group , a leader in the chemical industry with over 69 years of excellence, is proud to support national and international clients with sales and technical expertise. We are expanding our global reach and invite passionate professionals to grow with us....
-
hong kong, Hong Kong SAR China Vita Green Full timeAssistant QA Manager/Supervisor | Free Shuttle Bus | Growing Business Ready to Shape the Future of Health and Wellness? At Vita Green, we are all about creating a healthier, happier world, and we want you to be part of it! About Vita Green Group Vita Green stands at the forefront of the Health and Wellness supplements industry. Headquartered in Hong Kong,...
-
hong kong, Hong Kong SAR China Reetoo Biotech Full timeFounded in 2017 in Shenzhen, Reetoo is a pioneering In Vitro Diagnostics (IVD) company specializing in the research, development, manufacturing, and commercialization of AI-powered medical devices and reagents. Reetoo's diverse product portfolio includes solutions for urine analysis, vaginal secretion testing, hematology, sperm quality analysis, and...
-
Massphoton Limited | R&D Manager
4 days ago
hong kong, Hong Kong SAR China Massphoton Limited Full timeOn-site Full Time 15 year or below Mid-Senior level Skills: Driving license, Microsoft Office Suite, Report writing Summary: R&D Managers play a key role in the innovative and dynamic research and development teams. They are responsible for overseeing and coordinating research and development activities to drive product innovation, process improvements, and...
-
Vita Green | Quality Control
5 days ago
hong kong, Hong Kong SAR China Vita Green Full timeReady to Shape the Future of Health and Wellness? At Vita Green, we are all about creating a healthier, happier world, and we want you to be part of it! About Vita Green Group: Here at Vita Green, we are all about crafting something remarkable - be it careers, innovations, or impactful sales and marketing strategies! We believe every part of your journey can...
-
hong kong, Hong Kong SAR China Grifols, S.A Full timeWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...
