Department: CMC
Location: Guangzhou, Guangdong, China / Remote with regular travels to site on as needed basis
Employment type: full-time
Position Summary:
As a key member of Angitia’s leadership team, the ED/VP, CMC Process R&D leads the strategy, management, and execution of the early-stage development of biologic products (mAb, bispecific, and ADC). The early-stage development includes cell line selection, process developability, scale up, and cGMP production of tox, Phase I and Phase II manufacturing. This position plays a key role in organizational decision-making and will partner closely with fellow senior leaders (Clinical Development, CMC Operations, Project Management etc.) to ensure alignment between with Angitia’s long-term vision. Reporting to the CTO, the ED/VP, CMC Process R&D serves as the staff lead to the China based CMC team, the role holds primary responsibility for all aspects of CMC activities through Phase I/II clinical supply. The ED/VP, CMC Process R&D will own technical leadership across Drug Substance (DS), Drug Product (DP), Analytical Development, Cell Line Development, and device-enabled formulation development. This role will also be accountable for the sending site activities during technology transfer to late stage (Phase III and BLA). Angitia is translating innovative science into meaningful therapies for patients. With a growing pipeline, this is a unique opportunity to shape the technical foundation of a company at the intersection of scientific excellence and real-world impact. This role is China-based.
Position Responsibilities:
Strategic and Technical Leadership:
- Define and lead Angitia’s CMC development strategy from cell line selection through Phase II clinical supply of the pipeline.
- Establish clear technical standards for molecule development, formulation, analytical control strategies, and process scalability.
- Drive CMC planning for global regulatory submissions (INDs and IMPDs), including technical content for Module 3, comparability strategies, and direct support for regulatory inspections.
Functional Oversight:
- Drug Substance Development: Lead upstream and downstream process development, drug conjugation development, scale-up, and characterization to support early- stage programs.
- Cell Line Development: Oversee development, characterization, and banking of production cell lines to support robust, scalable manufacturing.
- Analytical Development: Drive method development, qualification, validation, and analytical lifecycle management to support product quality and regulatory filings.
- Drug Product & Formulation Development: Guide formulation design for IV and SubQ delivery, including high-concentration, device-compatible presentations.
Organizational & Cross-Functional Leadership:
- Build and lead a high-performing China based CMC development team.
- Collaborate closely with Regulatory, Quality, Supply Chain, Clinical, and Research to ensure technical alignment and execution across all programs.
- Serve as a core member of program governance and portfolio decision-making bodies.
Candidate Requirements:
- Ph.D. in Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field is required.
- Minimum requirement of years of experience in biologics development in industry with increasing leadership responsibility in CMC (mAb, Bispecific and xDC) will be commensurate with level: Executive Director ≥ 12 years, Vice President ≥ 16 years
- Demonstrated success in leading early stage CMC development, including IND/IMPD.
- Deep expertise in biologics process development (DS/DP), formulation science, analytical development, cell line development.
- Strong working knowledge of regulatory requirements (FDA, EMA, ICH) and experience supporting global health authority interactions.
- Proven ability to build and lead cross-functional technical teams in a fast-paced biotech environment.
- Strong bi-lingual (English and Chinese) efficiency ensuring seamless communications with global teams both internally and externally.
Note: the final job title will be commensurate with the candidate’s seniority, skills and level of experience.
About Angitia:
Established in June 2018, Angitia Biopharmaceuticals is a multinational research and development enterprise focusing on discovery and development of new drugs for grievous bone, muscle and joint diseases. The founder and the core team members of Angitia are seasoned scientific leaders in new drug discovery, development and management from both overseas and domestic large multinational companies. The company has built an organization distinguished by world-class scientists with talents that proficient in the pathophysiology of musculoskeletal diseases. We utilize cutting-edge technologies of genetics and molecular biology to uncover new mechanisms, signal transduction pathways and their interactions combined with computer aided drug design to identify new drug targets, and to discover and develop new biological and small molecule medicines. The company is committed to serving patients in need by carrying out innovative science includes internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking people who are competent, ambitious and great team players to join our vibrant group.
Our mission is to discover, develop and commercialize breakthrough therapeutics that address the key unmet medical needs of serious musculoskeletal diseases.
Learn more at www.angitiabio.com.
Top Skills
What We Do
Angitia is a clinical-stage biotechnology company focused on discovering and developing breakthrough therapeutics that address the key unmet medical needs of serious musculoskeletal diseases. With the team’s experience and scientific expertise in new drug development, Angitia is dedicated to bringing innovative therapeutics to help patients in need
