CMC Program Lead, China — CDMO & GMP Delivery

Dark Horse Consulting Group; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Dark Horse Consulting Group seeks an experienced CMC Program Manager for our China Office in Shanghai. You will own end-to-end CMC delivery from kickoff to GMP release, coordinating CDMO, CRO, and internal teams across process development, analytics, manufacturing and regulatory activities.

The role demands strong project management, proactive risk handling, and excellent communication with sponsors and global stakeholders.

Qualifications

• Bachelor's degree in Biologics, Pharmaceutical Sciences, Chemical Engineering, or related field.
• 5 years in pharma or a CDMO environment with strong project management in manufacturing.
• Solid CMC and regulatory knowledge in CGT including NMPA guidelines, GMP, lifecycle.
• Viral Vector experience is a plus.
• Proven ability to manage scope, deliverables, risks and resources with a track record of multi-stakeholder delivery.
• Proactive risk management to anticipate problems and communicate risks to senior stakeholders.
• Strong communication and interpersonal skills; ability to influence and build trust.
• Proficiency with MS Project or Smartsheet and Excel/PowerPoint.
• Mandarin proficiency preferred; willingness to travel.

Responsibilities

• Serve as the primary liaison between CDMO partners and sponsors.
• Lead end-to-end CMC program delivery across CDMO, CRO, and internal teams.
• Own project timelines and budgets; manage change orders.
• Coordinate technical transfer, cGMP manufacturing, and regulatory filing prep (China IIT projects).
• Lead non-clinical CRO and testing delivery for CMC.
• Organize governance activities and regular steering committee meetings.
• Ensure alignment across process development, analytics, manufacturing, quality, and regulatory teams.

Skills

PM leadership

Cross-functional collaboration

English communication

Mandarin proficiency (preferred)

Education

Bachelor's degree in Biologics/Pharmaceutical Sciences/Chemical Engineering

PMP or equivalent certification (plus)

Tools

MS Project

Smartsheet

Excel

PowerPoint

Job description

Dark Horse Consulting Group seeks an experienced CMC Program Manager for our China Office in Shanghai. You will own end-to-end CMC delivery from kickoff to GMP release, coordinating CDMO, CRO, and internal teams across process development, analytics, manufacturing and regulatory activities.

The role demands strong project management, proactive risk handling, and excellent communication with sponsors and global stakeholders.