CMC Program Manager

Job not on LinkedIn

🕒 August 14

🇨🇳 China – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

📋 Program Manager

Where this job comes from

Posted on Dark Horse Consulting Group's careers page, not through a job board

First seen by Remote Rocketship August 14

Logo of Dark Horse Consulting Group

Dark Horse Consulting Group

2 - 10 employees

Founded 2007

🎯 Recruiter

👥 HR Tech

💼 Consulting

Recruitment • HR Tech • Consulting

Dark Horse Consulting Group is a staffing and recruiting consultancy that specializes in staff resourcing, data reporting, and human-resources-focused consulting services. They offer recruitment and headhunting, employer branding, recruitment strategy, HRIS support, compensation reporting and analytics, and corporate culture transformation work. The firm positions itself as a B2B partner for companies seeking to hire top talent, make data-informed HR decisions, and improve recruiting processes and employer value propositions.

📋 Description

• Serve as the primary liaison and first-line contact between CDMO partners and sponsors. • Lead end-to-end CMC program delivery from technology transfer and process development through cGMP manufacturing and regulatory filing preparation. • Lead non-clinical CRO and testing delivery supporting comprehensive CMC delivery. • Own project timelines and budgets by building project plans, tracking progress, managing change orders, and maintaining financial oversight. • Identify and mitigate risks throughout the project lifecycle; escalate issues, drive resolution, and provide sponsors with timely updates. • Organize and lead core team meetings and Joint Steering Committee meetings. • Lead CDMO/CRO site visits and documentation reviews. • Coordinate execution across process development, analytical, manufacturing, quality, and regulatory teams. • Partner with clinical function groups across sponsor and DHC teams to ensure alignment, accountability, and progress visibility. • Report to the Head of China and oversee multiple CDMO projects for the client portfolio.

🎯 Requirements

• 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. • Proven ability to manage scope, deliverables, risks, and resources across complex, multi-stakeholder programs. • Proactive risk management skills, including anticipating problems, structuring mitigation plans, and clearly communicating risks to senior stakeholders. • Excellent interpersonal skills, including influencing without authority, navigating ambiguity, and building trust with internal teams and external partners. • Proficiency with MS Project or Smartsheet, Excel, and PowerPoint. • Strong English communication skills, written and verbal. • Willingness to travel to clinical sites, CRO offices, and hospitals as required. • PMP or equivalent certification is a plus. • Viral Vector experience is a plus. • Mandarin proficiency is preferred. • China IIT project experience is a plus.

Apply Now

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com
Follow Remote Rocketship on LinkedInFollow Remote Rocketship on InstagramFollow Remote Rocketship on FacebookFollow Remote Rocketship on TikTok