Senior Director, CMC Product Development

Senior Director, CMC Product Development

Remote – United States (Must live on the East-Coast)

Bring your end-to-end CMC expertise to a high-growth biotech that is re-engineering one of its flagship small-molecule programs for dramatically better patient outcomes. You will own formulation strategy, vendor partnerships, and late-stage readiness. If you thrive on turning scientific ambiguity into a robust commercial path, this is your next career milestone.

What You’ll Tackle

• Own end-to-end drug product strategy – Lead formulation design, analytical method development, and process scale-up appropriate to each clinical phase and future commercialization.
• Command external operations – Select and govern CDMOs/CROs, manage import–export compliance, and orchestrate tech transfer and trial-supply planning for a late-stage asset.
• Safeguard quality & efficiency – Provide technical oversight of DS and DP manufacture, driving process optimization, cGMP execution, and continuous improvement.
• Lead regulatory delivery – Craft and defend CMC sections of IND, NDA, BLA, and MAA filings in direct interactions with FDA, EMA, and other agencies.
• Build the supply network – Establish vendor agreements, monitor KPIs for cost, quality, and timeline, and implement risk-mitigation and budgeting controls.
• Inspire cross-functional excellence – Mentor scientists and partner with Quality, Regulatory, Clinical, and Commercial teams to align strategy and execution.

What You Bring

• PhD or MS in Chemical Engineering, Chemistry, Pharmaceutics, or related discipline.
• 10-15 yrs advancing small-molecule CMC programs from early process development to commercial readiness, including solid-oral dosage forms.
• Mastery of cGMP quality systems and hands-on oversight of U.S.-based and global CDMOs.
• Proven success leading rare-disease or other fast-track assets through late-stage milestones.
• Strategic thinker with crisp communication, budgeting acumen, and a bias for action in dynamic, virtual teams.

Why Join

• Mission-driven science – Your work directly accelerates a therapy with first-in-class potential.
• High visibility – Report to executive leadership and shape decisions that influence pipeline value.
• Flexibility & balance – 100 % remote role with core hours that respect your life outside the lab.
• Competitive package – Attractive salary, bonus eligibility, equity, and comprehensive benefits.

About Blue Signal:

Blue Signal is an award-winning, executive search firm specializing in various specialties. Our recruiters have a proven track record of placing top-tier talent across industry verticals, with deep expertise in numerous professional services. Learn more at bit.ly/46Gs4yS