CMC Program Manager — Global Biotech Projects

Dark Horse Consulting Group; Ulster; On-site; EUR 129,000 - 172,000; Full time

Job summary

Dark Horse Consulting Group, Inc. (DHCG) is seeking an experienced CMC Program Manager for our China Office to lead end-to-end CMC delivery across CDMO projects, ensuring quality, compliance and on‑time execution.

You will report to the Head of China and collaborate with process development, analytical, manufacturing, quality and regulatory teams. The ideal candidate has 5+ years in pharma or CDMO, solid CMC/regulatory knowledge (GMP, NMPA), strong program management skills, and excellent

Qualifications

• Bachelor’s degree in Biologics, Pharmaceutical Sciences, Chemical Engineering.
• 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.

Responsibilities

• Serve as the primary liaison between CDMO partners and sponsors, maintaining clear, consistent communication across all project phases.
• 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.
• Build realistic project plans, track progress, manage change orders, and maintain financial oversight to ensure on‑time, on‑budget delivery.
• Proactively identify and mitigate risks throughout the project lifecycle.
• Escalate issues early, drive resolution, and keep sponsors informed with timely, transparent updates.
• 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.
• 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.

Skills

Project management

Cross-functional collaboration

Risk management

Stakeholder management

Communication

Education

Bachelor’s degree in Biologics, Pharmaceutical Sciences, Chemical Engineering

Tools

MS Project

Smartsheet

Excel

PowerPoint

Job description

Dark Horse Consulting Group, Inc. (DHCG) is seeking an experienced CMC Program Manager for our China Office to lead end-to-end CMC delivery across CDMO projects, ensuring quality, compliance and on‑time execution.

You will report to the Head of China and collaborate with process development, analytical, manufacturing, quality and regulatory teams. The ideal candidate has 5+ years in pharma or CDMO, solid CMC/regulatory knowledge (GMP, NMPA), strong program management skills, and excellent