Head of CMC

ROLE: Head of CMC

COMPANY
Octant is a well-backed team of experienced scientists and entrepreneurs at the frontiers of biology, chemistry, and computation. We are a small molecule therapeutics company combining high-throughput synthetic biology, generative chemistry, and AI/ML to repeatedly develop precision medicines for genetically defined diseases.

JOB DESCRIPTION
Octant is seeking a highly experienced and motivated leader to establish and lead our Chemistry, Manufacturing, and Controls (CMC) function. This role is pivotal in driving the development and execution of the CMC strategy for our small molecule drug programs, with a primary focus on an accelerated clinical-stage program and additional early-stage assets. The ideal candidate will bring deep expertise in small molecule drug substance (DS) and drug product (DP) development, process chemistry, formulation, and regulatory filings, with the ability to drive execution in a fast-paced, resource-constrained environment.

As the primary CMC leader, this individual will oversee all aspects of DS/DP development, analytical characterization, manufacturing strategy, and regulatory submissions, working closely with external consultants, CDMOs, and internal stakeholders.

KEY RESPONSIBILITIES

CMC Strategy & Execution

• Define and implement CMC strategy, ensuring alignment with quality, non-clinical, clinical and regulatory teams.
• Establish scalable DS/DP manufacturing processes for clinical and commercial readiness.
• Drive phase appropriate process chemistry and formulation development.
• Select and manage CDMOs and consultants for timely execution.

Technical Leadership & Program Development

• Oversee DS/DP manufacturing activities
• Develop control strategies, specifications, and stability programs.
• Lead risk mitigation and compliance with accelerated regulatory pathways.
• Oversee high-quality CMC-related sections on regulatory submissions and interactions with health authorities.
• Integrate CMC with clinical and nonclinical development plans.

Operational & Cross-Functional Leadership

• Lead CMC execution, managing external partners and internal alignment.
• Oversee budgets, timelines, and CMC expansion.

Regulatory & Compliance

• Ensure global regulatory compliance and quality standards.
• Drive CMC content for regulatory filings and interactions.

THIS JOB MIGHT BE GREAT FOR YOU IF YOU HAVE:

Educational Background & Experience

• Ph.D. or M.S. in Chemistry, Chemical Engineering, Pharmaceutics, or related discipline, or equivalent experience.
• 10+ years in small molecule CMC development, including DS/DP, process chemistry, and filings.
• Experience as DS and/or DP lead for small molecule CMC programs.

Technical & Strategic Competency

• Expertise in small molecule DS and/or DP development, formulation, and process scale-up.
• Strong experience with outsourced manufacturing and CDMO oversight.
• Hands-on regulatory filings experience (IND, NDA, IMPD).
• Knowledge of stability programs and quality requirements.
• Familiarity with accelerated development strategies.

Leadership & Collaboration

• Proven ability to lead in a growing company and manage cross-functional and external teams.
• Execution-driven mindset in a dynamic environment.

Communication & Decision-Making

• Ability to simplify complex technical topics for diverse audiences.
• Strong decision-making balancing scientific, regulatory, and business needs.
• Passion for developing life-changing medicines with high-quality execution.

The expected annual salary for this role is in the range of $185,000 to $280,000, depending on experience level. We offer health benefits (medical, dental, vision), equity, and 401(k) matching.

Octant is located in Emeryville, California, and we work onsite.

Octant is an equal opportunity company that values applicants of all backgrounds. We’re committed to fostering an inclusive and supportive work environment. We value less traditional backgrounds and may consider an equivalent combination of knowledge, skills, education, and experience to meet minimum qualifications.