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Vice President of CMC (Base in China)

HitGen Inc.
INTERN Remote · US Boston, Massachusetts, US Posted: 2026-05-11 Until: 2026-06-10
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Job Description
The position requires working in Chengdu, China. I. Position Overview Lead the development and continuous evolution of an integrated API and formulation platform. Based on a multimodal portfolio of small molecules, cyclic peptides, and oligonucleotides, you will build a CMC development and manufacturing system covering the full lifecycle from preclinical through commercialization. By delivering deep technical expertise, a strong quality reputation, and reliable execution, you will transform the technology platform into a core competitive advantage that accelerates pipeline delivery. II. Key Responsibilities 1. Technology Platform & CMC Strategy – Define the top-level design and roadmap for the integrated API–formulation platform in alignment with the group's multimodal business (small molecules, cyclic peptides, oligonucleotides) and CDMO growth goals. Develop coordinated CMC strategies for both clinical and commercial stages, ensuring technical excellence, regulatory compliance, and cost efficiency to support corporate strategy. End-to-End Project Management & Collaboration –Ensure seamless synchronization of process development, analytical methods, and GMP manufacturing with overall project timelines. Lead resolution of critical technical issues, manage project risks, and guarantee high-quality, on-time delivery. 3. Quality System & Compliance Reputation – Build and continuously enhance a global-standard quality management system covering materials, production, quality control, and supply chain. Uphold the principle that "compliance is the product." Lead customer audits and regulatory inspections, significantly strengthening the company's compliance credibility and brand reputation as a trusted CDMO partner. Team Building & Organizational Capability – Establish a robust talent pipeline and management framework for the CMC team. Through systematic training, hands-on technical coaching, and management empowerment, elevate the team's capabilities in process development, project management, and cross-functional collaboration. Create dual career paths (technical and managerial) to cultivate a high-performing team with strong R&D expertise and a CDMO service mindset. III. Qualifications 1. Education & Technical Competence – Ph.D. in Medicinal Chemistry, Organic Chemistry, or a related field. Deep proficiency in the full process development, scale up, and technology transfer of both APIs and formulation. Prior CMC experience in peptide or oligonucleotide drugs is strongly preferred. Work Experience – 10+ years of R&D and manufacturing management experience in the pharmaceutical or CDMO industry, with a proven track record of leading CMC development for multiple innovative drug programs. 3. Industry Vision & Strategic Thinking – Deep insight into emerging trends and industrialization challenges in small molecules, cyclic peptides, or oligonucleotides. Ability to architect platform based, systematic technical frameworks; formulate platform strategies that are both technologically forward looking and commercially viable from the perspectives of customer needs and competitive dynamics. Quality & Compliance Mindset – Thorough knowledge of global GMP regulations and ICH guidelines, with hands on experience leading successful on site inspections by FDA, EMA, NMPA, or other authoritative bodies. Highly aware of quality risk prevention and control, and capable of embedding compliance requirements seamlessly across technology development and manufacturing operations. Leadership, Communication & Collaboration – Excellent strategic execution, cross departmental collaboration, and business communication skills. Customer centric, with the ability to align resources across R&D, manufacturing, quality, and commercial teams to drive complex project delivery efficiently. Proven success in building and leading high performance technical teams. Other HitGen offers an exciting and dynamic workplace environment that thrives on a growth mindset. Our team and business are growing. Expect to be an important and impactful contributor within a positive and business-minded team. The position requires working in Chengdu, China. If you are interested in this role, please apply with your current CV to: human.resources@hitgen.com