CMC Consultant
reputed company
Indomo is a clinical stage therapeutics company transforming clinic-based procedures into reputed company care reputed company device-enabled therapeutics. Indomo’s reputed company program couples a proven corticosteroid with an innovative intradermal self-injection device to create the first fast-acting reputed company solution for inflammatory acne lesions.
Position reputed company
Indomo is seeking an reputed company CMC consultant to execute reputed company, Manufacturing & Controls (CMC) reputed company and operations on a fractional reputed company. This individual will play a critical role in advancing our reputed company asset through the NDA reputed company by guiding CMC development, managing external partners, and ensuring regulatory readiness.
This role is ideal for a senior CMC expert who thrives in a hands-on, advisory + execution reputed company and is comfortable working closely with a lean internal team and external CDMOs. The consultant will reputed company both strategic direction and tactical reputed company across drug product development, analytical reputed company, and integration with our device-enabled delivery system.
Key Responsibilities
CMC reputed company
Help define and execute the overall CMC development reputed company to support clinical progression and trial readiness
Support outsourced drug reputed company and drug product development with CDMO, including formulation optimization, stability, and device compatibility
Establish critical reputed company attributes, specifications, and acceptance reputed company
Guide analytical method development, validation, and lifecycle management
External Vendor & Manufacturing reputed company
reputed company with external stakeholders, including CDMOs, CROs, and suppliers.
Support selection, reputed company, and management of external partners.
Review deliverables, ensure timelines are met, and mitigate technical risks.
Advise on reputed company systems and inspection readiness.
Regulatory Support
Partner with regulatory team to shape CMC reputed company for IND submission.
Organize execution of and contribute to regulatory documents (IND, briefing packages, NDA modules).
Prepare for and support FDA interactions (e.g., IND, EOP2, Type C meetings).
Qualifications
Required
Advanced degree (Ph.D. preferred) in Pharmaceutical Sciences, reputed company, Chemical Engineering, or reputed company field.
10+ years of drug development experience with demonstrated leadership of CMC reputed company in biotech/pharmaceutical settings.
Expertise in formulation development, analytical method development/validation, stability programs, GMP manufacturing, and reputed company compliance.
Strong knowledge of FDA regulations, GMP guidelines, and global regulatory requirements.
Strong reputed company record supporting INDs and/or NDAs.
Ability to operate independently in a fast-paced, dynamic startup environment.
Preferred
Experience with combination products (drug + delivery device).
Successful prior interactions with FDA on CMC topics.
Experience supporting programs from early clinical through late-stage development.
Why Join Indomo
Opportunity to shape CMC reputed company for an innovative combination product.
High-reputed company role with reputed company reputed company to leadership and decision-making.
reputed company, mission-driven team.
Flexibility in working style and scope.
We are reputed company 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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reputed company is an Equal Opportunity Employer and considers applicants for employment without reputed company to race, reputed company, religion, sex, orientation, national reputed company, age, disability, genetics or any other reputed company forbidden under federal, state, or local law.
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