CMC Consultant

<p><strong>About Us:</strong> </p> <p>Indomo is a clinical stage therapeutics company transforming clinic-based procedures into at-home care via device-enabled therapeutics. Indomo’s lead program couples a proven corticosteroid with an innovative intradermal self-injection device to create the first fast-acting at-home solution for inflammatory acne lesions.</p> <p><strong>Position Overview:</strong></p> <p>Indomo is seeking an experienced CMC consultant to execute Chemistry, Manufacturing &amp; Controls (CMC) strategy and operations on a fractional basis. This individual will play a critical role in advancing our lead asset through the NDA pathway by guiding CMC development, managing external partners, and ensuring regulatory readiness.</p> <p>This role is ideal for a senior CMC expert who thrives in a hands-on, advisory + execution capacity and is comfortable working closely with a lean internal team and external CDMOs. The consultant will provide both strategic direction and tactical oversight across drug product development, analytical strategy, and integration with our device-enabled delivery system.</p> <p><strong>Key Responsibilities:</strong></p> <p><strong>CMC Strategy</strong></p> <ul> <li> <p>Help define and execute the overall CMC development strategy to support clinical progression and trial readiness</p> </li> <li> <p>Support outsourced drug substance and drug product development with CDMO, including formulation optimization, stability, and device compatibility</p> </li> <li> <p>Establish critical quality attributes, specifications, and acceptance criteria</p> </li> <li> <p>Guide analytical method development, validation, and lifecycle management</p> </li> </ul> <p><strong>External Vendor &amp; Manufacturing Oversight</strong></p> <ul> <li> <p>Interface with external stakeholders, including CDMOs, CROs, and suppliers.</p> </li> <li> <p>Support selection, onboarding, and management of external partners.</p> </li> <li> <p>Review deliverables, ensure timelines are met, and mitigate technical risks.</p> </li> <li> <p>Advise on quality systems and inspection readiness.</p> </li> </ul> <p><strong>Regulatory Support</strong></p> <ul> <li> <p>Partner with regulatory team to shape CMC strategy for IND submission.</p> </li> <li> <p>Organize execution of and contribute to regulatory documents (IND, briefing packages, NDA modules).</p> </li> <li> <p>Prepare for and support FDA interactions (e.g., IND, EOP2, Type C meetings).</p> </li> </ul> <p><strong>Qualifications:</strong></p> <p><strong>Required</strong></p> <ul> <li> <p>Advanced degree (Ph.D. preferred) in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.</p> </li> <li> <p>10+ years of drug development experience with demonstrated leadership of CMC strategy in biotech/pharmaceutical settings.</p> </li> <li> <p>Expertise in formulation development, analytical method development/validation, stability programs, GMP manufacturing, and quality compliance.</p> </li> <li> <p>Strong knowledge of FDA regulations, GMP guidelines, and global regulatory requirements.</p> </li> <li> <p>Strong track record supporting INDs and/or NDAs.</p> </li> </ul> <ul> <li> <p>Ability to operate independently in a fast-paced, dynamic startup environment.</p> </li> </ul> <p><strong>Preferred</strong></p> <ul> <li> <p>Experience with combination products (drug + delivery device).</p> </li> <li> <p>Successful prior interactions with FDA on CMC topics.</p> </li> <li> <p>Experience supporting programs from early clinical through late-stage development.</p> </li> </ul> <p><strong>Why Join Indomo:</strong></p> <ul> <li> <p>Opportunity to shape CMC strategy for an innovative combination product.</p> </li> <li> <p>High-impact role with direct access to leadership and decision-making.</p> </li> <li> <p>Collaborative, mission-driven team.</p> </li> <li> <p>Flexibility in working style and scope.</p> </li> </ul> <p>We are focused on building a diverse and inclusive workforce. If you’re excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.</p> <p>-----</p> <p>Atomic is an Equal Opportunity Employer and considers applicants for employment without regard to race, color, religion, sex, orientation, national origin, age, disability, genetics or any other basis forbidden under federal, state, or local law.</p> </p> <p>Please review our <a href="https://www.atomic.vc/job-applicant-privacy" rel="nofollow ugc noopener" target="_blank">CCPA policies</a> here.</p>