DirectorHead of CMC

Company Overview

TwoStep Therapeutics is a biotechnology company developing a pipeline built around a unique tumor-targeting polyspecific integrin-binding peptide (PIP) that can selectively bind several targets that are highly expressed on solid tumors. This multi-targeting feature enables the agents broad applicability to a wide range of tumor types and patient populations overcoming the limitations of single-antigen targeting approaches. The company has leveraged this technology to create a pipeline of targeted cancer therapies for cytotoxic drug delivery and radioligand therapy. TwoStep Therapeutics was co-founded by CEO Caitlyn Miller in collaboration with leading academic entrepreneurs at Stanford University including Nobel Laureate Carolyn Bertozzi Jennifer Cochran and Ronald Levy.

For more information visit or download our 2025 scientific poster (linked here).

Position Overview

TwoStep Therapeutics is seeking a hands-on Director/Head of CMC to lead execution of our Chemistry Manufacturing and Controls (CMC) strategy across a growing therapeutic portfolio. This role will be responsible for translating early development programs into robust scalable and regulatory-ready processes capable of supporting clinical development.

The ideal candidate is an experienced CMC leader who thrives in a fast-paced biotech environment takes full ownership of deliverables and has a strong track record of advancing peptide small molecule and radiopharmaceutical programs through early clinical development within an outsourced manufacturing model.

While this role is envisioned as a full-time position we are open to part-time or hourly consulting arrangements for highly qualified candidates particularly those with deep expertise in CMC development of radioligand assets.

Key Responsibilities

• Own and execute phase-appropriate CMC development plans from discovery handoff through clinical development

• Lead all drug substance (DS) and drug product (DP) activities including process development and optimization cGMP manufacturing analytical development (including method validation and stability programs) and formulation development (fill/finish lyophilization optimization etc.)

• Oversee CMC execution for radioligand programs including management of radioisotope suppliers radiochemistry development partners and clinical radio-CMC operations

• Drive selection contracting and management of CDMOs to ensure high-quality and on-time phase-appropriate batch delivery to external vendors/clinical sites

• Manage timelines and budgets monitor performance metrics and proactively mitigate technical and supply chain risks

• Ensure compliance with cGMP ICH guidelines and global regulatory standards across all CMC activities

• Lead preparation authoring and review of CMC sections for regulatory submissions (INDs IMPDs NDAs and future BLAs/MAAs). Serve as CMC technical lead in regulatory interactions with FDA EMA and other health authorities

• Serve as the CMC subject matter expert on cross-functional program discussions across Research Nonclinical Development Clinical Development and Quality Assurance

Essential Qualifications

• Advanced degree in a relevant field (Chemical Engineering Biomedical Engineering Biochemistry Pharmaceutical Sciences etc.) or equivalent experience in CMC development

• A minimum of 5 years of progressive experience in the biopharmaceutical industry with extensive experience in the CMC development of peptides and/or small molecules from early process development to the clinic

• Demonstrated expertise in radiopharmaceutical CMC development (radiolabeling analytical methods formulation considerations and supply logistics)

• Proven experience operating within a fully outsourced manufacturing model including CDMO selection contracting oversight and performance management.

• Deep working knowledge of cGMP requirements ICH guidelines and global regulatory expectations with hands-on experience authoring and reviewing CMC modules for regulatory submissions

• Strong project management skills with the ability to balance technical depth and program timelines

• Comfortable operating in a lean high-growth biotech environment where adaptability and accountability are essential

Preferred Qualifications

• Experience with radiopharmaceutical site selection method transfer and evaluating clinical site readiness

• CMC experience with peptide-drug conjugates

• Experience supporting late-stage clinical development or commercial readiness activities

What We Offer
At TwoStep Therapeutics we envision a future where every cancer patient has access to targeted safe and effective therapeutic options. We prioritize a diverse inclusive work environment that fosters personal and professional growth. Our comprehensive benefits include:

• Competitive base salary performance bonuses and equity compensation

• Unlimited Paid Time Off (PTO)

• Comprehensive medical dental and vision benefits for individuals and families

• 401(k) plan

• Company-paid basic life insurance

Job title and compensation are dependent on the candidates experience and skillset. We will consider candidates who prefer to work in-person (San Carlos CA) hybrid or remote.

Equal Opportunity Employer
TwoStep Therapeutics is an equal opportunity employer. We prohibit unlawful discrimination based on race color religion gender sexual orientation gender identity/expression national origin/ancestry age mental/physical disability medical condition marital status veteran status or any other characteristic protected by law. If you require assistance in submitting an application due to incompatible assistive technology or a disability please contact us at We are committed to accommodating your needs promptly.

Join Us
If you are passionate about advancing cancer therapies and want to make a meaningful impact in the field we invite you to apply for the Director/Head of CMC position at TwoStep Therapeutics. Together we can shape the future of cancer treatment.

Required Experience:

Director