CMC Program Manager

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

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 CDMOCRO 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

Qualifications

Bachelors 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

Key Competencies

Cell and Gene Therapy CDMO experience CMC & GMP China IIT NMPA regulations Project management Viral Vectors Cell Therapies mRNA PMP certificate Native in Mandarin Fluent in English