What are the responsibilities and job description for the Director, CMC position at Adaxion Therapeutics?

Adaxion Therapeutics, headquartered in San Diego, CA, is a development stage biotechnology company focused on bringing first-in-class and best-in-class therapeutics to patients with autoimmune and inflammatory disease. With its proprietary deimmunization technology, Adaxion is revolutionizing the development of otherwise immunogenic biologic therapeutics to address a wide range of unmet medical needs. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients.

Key Responsibilities

The Adaxion Therapeutics Director of CMC is a critical role responsible for executing Chemistry, Manufacturing, and Controls (CMC) strategies for the company's product portfolio. Adaxion develops and manufactures pipeline biotherapeutics through relationships with multiple Contract Development and Manufacturing Organizations (CDMOs).

This position is an individual contributor role, working closely with the head of CMC, CMC Project Manager, and CTO to ensure successful and timely delivery of CMC goals.

Key responsibilities include :

Providing operational and strategic leadership for process development, analytical development, manufacturing, quality, and supply chain.
Serving as the technical / operational point of contact with partner CDMOs and leading the selection, evaluation, and relationship management of external vendors and service providers.
Guiding technology transfer, process development, optimization, qualification, and validation activities related to manufacturing operations.
Reviewing and co-authoring CMC sections of regulatory filings, including INDs.
Working closely with cross-functional teams to align with key stakeholders in CMC, Clinical, Quality Assurance, and Regulatory departments.
This position will be the primary technical contact for all process development and manufacturing related activities with contract manufacturing and other organizations.
Contributing to a fast-paced, dynamic, data-driven scientific culture that embraces innovation and excellence.

Prerequisites and Qualifications

Education and Experience

Ph.D. in Biochemistry, Chemistry, Bioengineering, or a related discipline.

Minimum of 10-15 years of experience in biotech / pharma biotherapeutics and / or small molecule CMC.

The ideal candidate will have experience in one or more of the following areas : API process chemistry, analytical development, bioconjugate CMC

Direct experience in advancing programs through preclinical and clinical development and manufacturing.

Skills and Competencies

Experience with preclinical and clinical stage CMC development and manufacturing of novel therapeutics.

Applied experience with relevant regulatory guidelines and development of manufacturing sections for regulatory filings.

Strong expertise in GMP and non-GMP best practices.

Expertise in at least two CMC areas, such as biotherapeutic upstream and downstream processing, small molecule process chemistry, analytical development, formulation development, or QC.

Bioconjugate experience (e.g., Antibody Drug Conjugates, PEGylated protein therapeutics) is preferred.

Excellent written and oral communication skills, with the ability to work effectively in a diverse team environment.

Some travel may be required, including domestic and international (5-10%)

The ideal candidate would be based in San Diego, with relocation to be determined

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