CMC Lead - Biologics (On-site, Morrisville, NC)

Job Description

Job Description

CMC Lead – Biologics (On-site, Morrisville, NC)
Inhalon Biopharma and Mucommune, LLC

Before you apply, please note:

• On-site only. This role works from our Morrisville lab five days a week. Remote and hybrid applicants will not be considered.
• Resourceful by nature. We give priority to people who have thrived in lean biotech settings, where budgets are tight and making smart trade-offs is part of the job.
• Flexible start. We are open to starting part-time and moving to full-time as the programs grow.

About the role
Two Triangle biotechs share one antibody platform. Inhalon develops inhaled antibody therapies, and Mucommune develops non-hormonal contraceptive products. Both programs are heading into clinical trials. As CMC Lead, you will run drug substance and drug product campaigns with our contract manufacturers, from cell line development through GMP release. This is a hands-on role: you will do the work yourself, not oversee a team.

What you’ll do

• Be the day-to-day contact for our CDMOs: run project meetings, track deliverables, and manage scope and cost.
• Write and review batch records, tech transfer documents and specifications, and work deviations through to closure.
• Build and maintain the integrated schedule (Gantt) and risk register for every campaign.
• Support drug product development, stability programs and the CMC sections of regulatory filings.
• Represent the company on-site at manufacturing runs.

What you bring

• A BS or MS in chemical engineering, biochemistry, pharmaceutical sciences or a related field, with 3–7 years in biologics development or manufacturing. A PhD with 1–3 years in industry also qualifies.
• Hands-on work on at least two GMP drug substance or drug product runs, from either the sponsor side or inside a CDMO.
• Experience writing or reviewing batch records and managing deviations.
• A working knowledge of monoclonal antibody manufacturing and release testing.
• Strong organization and clear writing, and comfort holding vendors to dates and budgets.

Nice to have

• Experience with lyophilization, solid dosage forms, drug–device combination products, or inhaled biologics.

Why join
You will own CMC for two programs at a stage where your decisions shape the outcome, with direct access to senior leadership.

Inhalon Biopharma and Mucommune are equal opportunity employers.