Atomic
CMC Consultant
Remote role where the employee must remain based in a particular country.
United States only
Employer listed it 5 months ago · Added yesterday
Been open since 5 months ago. Long-running listings are sometimes left up after the role is filled.
Salary
Not stated
Location
United States only
Timezone
Not stated
Contract
Contract
Experience
Senior
Category
Other
This employer didn't state pay. Jobs like this usually pay around $125k–$205k a year, a typical range taken from 166 senior-level other roles on Nomaders that do state pay. It's a guide, not an offer.
Remote flexibility
Work from home
This is a remote role, but the employee must be based in United States. It is work from home rather than work from anywhere.
What the employer says
- Source listing states candidate location: "Remote - US"
What Nomaders makes of it
- Residency required in United States
- Payroll and tax are likely handled in that country only
The quotes above are the employer's own words; the reading is ours. Always check the original listing and employment terms before working from another country.
About the role
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.
Position Overview:
Indomo is seeking an experienced CMC consultant to execute Chemistry, Manufacturing & 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.
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.
Key Responsibilities:
CMC Strategy
Help define and execute the overall CMC development strategy to support clinical progression and trial readiness
Support outsourced drug substance and drug product development with CDMO, including formulation optimization, stability, and device compatibility
Establish critical quality attributes, specifications, and acceptance criteria
Guide analytical method development, validation, and lifecycle management
External Vendor & Manufacturing Oversight
Interface with external stakeholders, including CDMOs, CROs, and suppliers.
Support selection, onboarding, and management of external partners.
Review deliverables, ensure timelines are met, and mitigate technical risks.
Advise on quality systems and inspection readiness.
Regulatory Support
Partner with regulatory team to shape CMC strategy 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, Chemistry, Chemical Engineering, or related field.
10+ years of drug development experience with demonstrated leadership of CMC strategy in biotech/pharmaceutical settings.
Requirements
- ·Advanced degree (Ph.D. 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.
- ·Strong track record supporting INDs and/or NDAs.
Benefits
No benefits package published with this listing. Ask about it at first interview.
How to apply
- 1Check the flexibility label above, work from home, matches where you plan to live and work.
- 2Tailor your CV to the role at Atomic, mentioning your remote working experience.
- 3Apply directly on the employer's careers page using the button below. Nomaders never handles your application.
Found 1d ago. Last checked today. Always confirm the details on the original posting, salary and location can change after publication.
Listing sourced from Company boards.
Similar roles
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Typically $125k–$205k · You'll be taken to the employer's careers page.