Drug CMC Lead

About the role

You will own the end-to-end Chemistry, Manufacturing & Controls (CMC) strategy for Indomo's at-home therapeutic portfolio. You will drive the development and regulatory execution of a drug-device combination product advancing through the NDA pathway. This role requires you to build and lead CMC operations while ensuring seamless integration of formulation, analytical strategy, and manufacturing with the device component. You will act as the primary technical leader interfacing with CDMOs, suppliers, and regulatory authorities to de-risk development and manufacturing. The position demands a high degree of ownership, proactive problem-solving, and rigorous adherence to cGMP standards. You will be responsible for translating complex technical requirements into actionable plans that keep clinical and commercial programs on schedule.

Key facts

What you'll do

• Lead the CMC strategy and execution for Indomo's drug and combination product portfolio, aligning with corporate objectives.
• Oversee outsourcing and management of drug substance and drug product development at Indomo's CDMO, including formulation optimization, stability, and compatibility with the drug delivery system.
• Set technical requirements and acceptance criteria for drug quality attributes, drug-device interface compatibility, and analytical performance.
• Manage analytical method development, validation, and qualification for release and stability testing in support of clinical and commercial needs.
• Define comparability strategies for clinical and commercial lots, ensuring robust bridging from legacy formulations to scaled, controlled processes.
• Act as the Company's primary point of contact for external stakeholders, including CDMOs, suppliers, and regulatory consultants.
• Select and manage CDMOs for drug substance and drug product manufacture, negotiating Statement of Work agreements and ensuring alignment with development timelines.
• Drive technology transfer, scale-up, GMP manufacturing, and stability programs while implementing rigorous quality systems for cGMP compliance.
• Lead development and execution of the CMC strategy to support Investigational New Drug (IND) and New Drug Application (NDA) submissions.
• Define regulatory pathways and advise on evidence needs in partnership with regulatory affairs for both drug and combination products.
• Engage with the FDA and other regulatory authorities on CMC components of submissions, including pre-IND, End-of-Phase 2 meetings, and Type C discussions.
• Partner with clinical operations, regulatory affairs, quality assurance, device engineering, and external partners to align on timelines, risk mitigation, and integrated submission packages.
• Serve as a core member of the product leadership team, providing CMC insight for go/no-go decisions and clinical planning.
• Mentor junior engineers and promote best practices to foster collaboration across internal functions and external partners.

Requirements

• Advanced degree preferred in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.
• 10+ years of drug development experience with demonstrated leadership of CMC strategy in biotech or pharmaceutical settings.
• Expertise in formulation development for drug products and drug-device combination products.
• Demonstrated experience in analytical method development, validation, and qualification for release and stability testing.
• Strong knowledge of FDA regulations, Current Good Manufacturing Practice (cGMP) guidelines, and global regulatory requirements for drug products.
• Proven ability to scale products from early clinical development through pivotal trials and into commercial manufacturing.
• Exceptional leadership, management, and cross-functional collaboration skills.
• Excellent communication and problem-solving abilities in a fast-paced, dynamic environment.
• Ability to work effectively with external partners including CDMOs, suppliers, and regulatory consultants.
• High ownership mindset with strong organizational and project management skills.
• Willingness to engage in frequent interaction with regulatory authorities on CMC topics.
• Commitment to maintaining rigorous quality standards and compliance in all manufacturing and control activities.
• Readiness to contribute to strategic decisions that impact clinical timelines and regulatory success.
• Demonstrated experience managing technical documentation and regulatory dossiers for complex drug products.

Nice to have

• Proven track record of managing CMC for combination products (drug + delivery device).
• Successful interactions with the FDA on CMC topics, including experience through regulatory inspections.

Practical notes

This is a full-time remote position based in the United States. The role involves frequent interaction with external stakeholders and may require travel as needed for project requirements or regulatory engagements. Visa sponsorship is not available for this position. Applicants must meet the stated requirements and align with the core responsibilities outlined above.