CMC Project Leader

Job Description

Job Description

CMC Project Leader

Boston, MA | Frequent International Travel | Full-Time | CMC - Oligonucleotide

Pay Range: $140,000–$190,000 per year

Since our founding in 1998, Hongene has been at the forefront of nucleic acid chemistry, earning global recognition for delivering high-purity building blocks that powered the early development of RNA therapeutics. Over the years, we have expanded beyond raw materials to become a trusted CDMO partner for oligonucleotide and mRNA medicines. Through sustained investment in infrastructure, talent, and innovation, we continue to scale cutting-edge science — helping our partners advance the next generation of nucleic acid therapeutics from discovery to market.

About the Role

The CMC Project Leader plays a central role in advancing Hongene's oligonucleotide contract manufacturing portfolio, serving as a key liaison between global clients and our cross-functional teams. The role calls for strong scientific grounding, disciplined project management, and the ability to navigate complex technical and regulatory landscapes. It reports to the VP, Global Head of CMC & Regulatory, and level (Senior Manager through Director) will be determined based on the candidate's experience.

You'll need strong communication skills to engage strategically with internal and external stakeholders, fluency in both English and Mandarin, and the drive to thrive in a fast-paced, entrepreneurial environment.

What You'll Do

• Drive project management efforts associated with CMC activities supporting oligonucleotide contract manufacturing projects at Hongene Biotech.
• Support the Head of CMC and the Oligonucleotide team in developing and executing development and manufacturing strategy and tactical execution plans.
• Bridge communication between clients and internal teams across multiple contract manufacturing projects — participating in technical calls, tracking action items, and facilitating rapid decision-making to keep programs moving.
• Coordinate with AD/PD, Manufacturing, Quality, and BD teams to build and manage global client project timelines; support BD in generating RFP proposals, evaluating resource needs, and aligning proposals with strategy and cost estimates. Proactively identify risks, resourcing constraints, and conflicts, and collaborate with cross-functional teams on solutions.
• Support projects with strategic partners in the US.

Minimum Qualifications

• B.S. or M.S. in Pharmaceutical Science, Chemistry, Biochemistry, or a related scientific discipline, with 8+ years of applicable experience in the biotechnology or pharmaceutical industry.
• Demonstrated proficiency in project management, including experience operating in a GMP environment and working cross-functionally.
• Demonstrated ability to exercise independent judgment and strategic thinking.
• Strong interpersonal skills and experience managing cross-functional projects.
• Ability to thrive in a fast-paced, hands-on research and development environment.
• Adept at building strong relationships and collaborating with colleagues at all levels.
• Ability to discern a path forward in ambiguous environments.
• Excellent verbal, written, and presentation skills for communicating with internal and external stakeholders.

Preferred Qualifications

• Minimum of 5 years' experience in project or program management at a biotechnology or pharmaceutical company, with direct involvement in the CMC area.
• Experience with project management tools (e.g., MS Project, Smartsheet, Clarizen) and collaboration tools (Box, SharePoint, MS Teams).
• Understanding of the different phases of drug development and cGMP requirements.
• Experience in small molecule, oligonucleotide, or biologic drug development.
• Located in the US Eastern time zone.

Location & Travel

Boston, MA area preferred. This role includes frequent travel between the US and Hongene's home office in Shanghai, China.

Hongene Biotech Corporation is an Equal Opportunity Employer.