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As a brand, Atomic brings together ideas, capital, resources, and talent to create exceptional companies. They are dedicated to partnering with co-founders to transform the best ideas into successful ventures. At Atomic, they believe in the power of collaboration and strategic investment. They identify promising startups, providing them with the necessary funding and support to thrive in today's competitive market. Their team of experts not only brings financial backing but also valuable guidance and industry expertise to help these companies reach their full potential. With a focus on innovation and disruption, Atomic is constantly on the lookout for groundbreaking ideas and entrepreneurs who are ready to make a mark. By offering a unique blend of financial assistance, mentorship, and access to a network of industry leaders, Atomic empowers startups to overcome challenges and achieve lasting success. Whether you are an aspiring entrepreneur or an established startup, partnering with Atomic can fuel your growth and help you navigate the ever-changing business landscape. It's time to unlock your company's potential with Atomic.

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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.
- 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.
- 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.

## Employment Details

**Location:** Remote - US

**Employment Type:** Contract

**Department:** Indomo

CMC Consultant  @ Atomic

Product Development

Marketing Consultant

Indomo is seeking an experienced CMC consultant to execute Chemistry, Manufacturing & Controls (CMC) strategy and operations on a fractional basis. This role involves guiding CMC development, managing external partners, and ensuring regulatory readiness for a clinical stage therapeutics company.

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