Position: CMC Program Manager
Hours: Full Time
Report to: Head of China
Location: Shanghai, China
About the Company
Dark Horse Consulting Group, Inc. (DHCG) is a rapidly growing life science consulting company that employs approximately 100 professionals across the United States, Europe, and APAC. We provide a comprehensive range of technical and strategic consulting services spanning the full spectrum of drug development and related business strategy to clients in the advanced therapies and biotherapeutics industries. Our clients include therapeutic developers, tools and technology companies, service providers, venture capital and private equity firms, and academic institutions. As the leading global consulting company in the advanced therapies space, we pride ourselves on providing high quality, expert service to enable the development of cutting-edge therapies for patients in need.
Position Summary
We are seeking an experienced and hands-on CMC Program Manager located in our China Office for our rapidly growing global consulting organization. This role reports to Head of China and has full responsible to lead and oversee multiple CDMO projects for our client portfolio. In this critical role, you will own the end-to-end CMC delivery, from project kick-off to GMP manufacturing release, ensuring quality, compliance, and on-time execution across CDMO, non-clinical CRO and internal stakeholders.
The ideal candidate will be a proactive, solutions-oriented leader with a proven track record in successfully managing complex CMC programs from start-up through regulatory filing. You thrive in dynamic environments, excel at cross-functional collaboration, and possess exceptional organization and communication skills. China IIT project experience is a plus.
Responsibilities:
Serve as the primary liaison
- Act as the first line contact between CDMO partners and sponsors, maintaining clear, consistent communication across all project phases.
Lead end-to-end CMC program delivery
- Lead the CDMO delivery spanning tech transfer, process development, cGMP manufacturing, and regulatory filing preparation, with particular ownership of China IIT projects.
- Lead the non-clinical CRO and testing delivery to support comprehensive CMC delivery.
Own project timelines and budgets
- Build realistic project plans, track progress, manage change orders, and maintain financial oversight to ensure on-time, on-budget delivery
Risk Management
- Proactively identify and mitigate risks throughout the project lifecycle.
- Escalate issues early, drive resolution, and keep sponsors informed with timely, transparent updates.
Organize joint governance activities
- Set up and head regular core team meetings including Joint Steering Committee meetings.
- Lead CDMO/CRO site visits and documentation reviews, ensuring all stakeholders are aligned.
Cross-functional collaboration
- Coordinate project execution across process development, analytical, manufacturing, quality, and regulatory teams to align priorities and resolve dependencies.
- Partner closely with clinical function groups across the sponsor team and DHC to ensure alignment, accountability, and progress visibility.
- Bachelor’s degree in Biologics, Pharmaceutical Sciences, Chemical Engineering, or a related field.
- 5+ years in pharma or a CDMO environment, with a strong foundation in project management within manufacturing environments.
- Solid CMC and regulatory knowledge in CGT, including familiarity with NMPA guidelines, GMP manufacturing standards, and the drug development lifecycle. Viral Vector experience is a plus.
- Proven ability to manage scope, deliverables, risks, and resources, with a track record of successful delivery across complex, multi-stakeholder programs.
- Proactive risk management instincts — able to anticipate problems, structure mitigation plans, and communicate risks clearly to senior stakeholders.
- Excellent interpersonal skills — able to influence without authority, navigate ambiguity, and build trust with internal teams and external partners alike.
- Proficiency with project management tools such as MS Project or Smartsheet and standard tools such as Excel and PowerPoint. PMP or equivalent certification is a plus.
- Strong English communication skills (written and verbal); Mandarin proficiency is preferred given the China-based site network.
- Willingness to travel to clinical sites, CRO offices, and hospitals as required.
- Viral Vectors / Cell Therapies / mRNA
- Native in Mandarin, Fluent in English
