Head of CMC

ROLE:Head of CMC

COMPANY
Octant is a wellbacked team of experienced scientists and entrepreneurs at the frontiers of biology chemistry and computation. We are a small molecule therapeutics company combining highthroughput 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 of the CMC strategy for our small molecule drug programs with a primary focus on an accelerated clinicalstage program and additional earlystage 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 in a fastpaced resourceconstrained 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 &

• Define and implement CMC strategy ensuring alignment with quality nonclinical 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 .

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 highquality CMCrelated sections on regulatory submissions and interactions with health authorities.
• Integrate CMC with clinical and nonclinical development plans.

Operational & CrossFunctional Leadership

• Lead CMC 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 scaleup.
• Strong experience with outsourced manufacturing and CDMO oversight.
• Handson 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 crossfunctional and external teams.
• Executiondriven mindset in a dynamic environment.

Communication & DecisionMaking

• Ability to simplify complex technical topics for diverse audiences.
• Strong decisionmaking balancing scientific regulatory and business needs.
• Passion for developing lifechanging medicines with highquality .

The expected annual salary for this role is in the range of $185000 to $280000 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. Were 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.