About this role.
Indomo is seeking a senior Drug CMC Lead to own Chemistry, Manufacturing & Controls strategy and execution for a clinical-stage drug and combination-product portfolio. The role leads formulation, analytical development and validation, stability, technology transfer, GMP manufacturing, and CDMO oversight. This leader will build CMC packages supporting IND and NDA milestones and engage with FDA and other regulatory authorities on CMC matters. Reporting to the CEO, the position requires cross-functional leadership across clinical, regulatory, quality, device engineering, suppliers, and external manufacturing partners.
Role DNA
A quick view of the complexity, pace, ownership and collaboration implied by the job description.
Job Complexity
5/5Pace & Pressure
5/5Autonomy Level
5/5Communication Load
5/5Salary analysis
Estimated compensation compared with the broader US market for similar roles.
Core skills
Skills and capabilities most closely associated with this opportunity.
Sample interview questions
I would explain the target product profile, critical quality attributes, formulation and analytical plans, manufacturing strategy, and key regulatory risks. I would also quantify how the strategy enabled clinical supply, comparability, and submission readiness.
I begin with a cross-functional risk assessment covering drug formulation, extractables and leachables, dose delivery, device compatibility, container closure, and human-use considerations. I establish clear ownership, acceptance criteria, and testing plans so that drug and device changes are evaluated together.
I assess technical capability, quality history, capacity, regulatory inspection readiness, project management discipline, and fit with the development timeline. After selection, I use a detailed scope of work, governance cadence, milestone-based deliverables, and transparent escalation paths to maintain accountability.
I would identify the process changes and assess their potential impact on critical quality attributes, then define a science- and risk-based analytical comparability package. The plan would include representative lots, stability data, predefined acceptance criteria, and regulatory alignment appropriate to the development stage.
I prepare concise briefing materials that clearly state the product, development history, key questions, supporting data, and proposed path forward. During the meeting, I ensure technical experts provide consistent, evidence-based responses and translate agency feedback into owned actions, timelines, and submission updates.
About Us:
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. We are seeking a versatile and experienced CMC Lead to lead our drug development and manufacturing.
Position Overview:
Reporting to the CEO, you will own and execute the Chemistry, Manufacturing & Controls (CMC) strategy and operations for Indomo’s drug and combination product portfolio. This leader will drive the advancement of our lead asset through the NDA regulatory pathway, while effectively coordinating cross-functional efforts to integrate drug formulation, analytical strategy, and manufacturing with the medical device component of Indomo’s drug delivery system.
This role requires deep expertise in regulatory CMC requirements (especially drug product and formulation development, analytical method development/validation, manufacturing scale-up, and quality/regulatory interfacing for combination products). The ideal candidate will be adept at building robust CMC packages that support clinical milestones and regulatory submissions. This individual must be highly self-motivated, optimization-minded, and collaborative amongst internal stakeholders as well as CDMO’s and other external partners as appropriate, with a deep sense of personal ownership of deliverables.
Key Responsibilities:
CMC Program Leadership
Oversee outsourcing and management of drug substance and drug product development at Indomo’s CDMO — including formulation optimization, stability, and compatibility with Indomo’s 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.
Define comparability strategies for clinical and commercial lots, bridging legacy formulations to scaled, controlled processes.
Manufacturing & Supply Chain
Act as the Company’s primary point of contact for external stakeholders, including CDMOs and suppliers.
Select and manage CDMOs for drug substance and drug product manufacture; negotiate SOWs and ensure alignment with development timelines.
Drive technology transfer, scale-up, GMP manufacturing, and stability programs.
Implement rigorous quality systems ensuring compliance with cGMP and readiness for regulatory inspections.
Strategy & Regulatory
Lead development and execution of CMC strategy to support IND and eventual NDA submission.
Define regulatory pathways and advise on evidence needs in partnership with regulatory affairs for drug and combination products.
Engage with the FDA and other regulatory authorities on CMC components of submissions (e.g., pre-IND/End-of-Phase 2 meetings, Type C discussions).
Cross-Functional Collaboration & Team Building
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, promote best practices, and foster collaboration across functions.
Qualifications:
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/pharmaceutical settings.
Expertise in formulation development, analytical method development/validation, stability programs, GMP manufacturing, and quality compliance.
Strong knowledge of FDA regulations, GMP guidelines, and global regulatory requirements.
Experience scaling products from early clinical through pivotal and commercial manufacturing.
Exceptional leadership and management skills.
Excellent communication and problem-solving abilities.
Ability to work in a fast-paced, dynamic startup environment.
Preferred
Proven track record of managing CMC for combination products (drug + delivery device).
Successful interactions with FDA on CMC topics; experience through regulatory inspections.
What We Offer:
Opportunity to shape and lead drug development in a groundbreaking therapeutics startup.
Competitive compensation and benefits package, including equity options.
Collaborative and mission-driven culture.
Growth opportunities as the company advances through clinical stages and expands pipeline.
Compensation: $150k – $215k salary + equity
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.
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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.
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