Director, CMC Product Development - Small Molecule

The posting, as Beeline Medicines wrote it

About Beeline Medicines

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

Job Summary

The Director, CMC Product Development – Small Molecule is a senior technical and operational leader responsible for the end-to-end CMC development of small molecule drug product candidates, from early formulation through process development, clinical supplies, and regulatory submission. Reporting to the Executive Director, CMC Product Development, this individual drives the drug product development activities on assigned programs. This role carries no direct reports but works cross-functionally with internal teams and external CDMO drug product partners. It requires deep expertise in small molecule formulation science and manufacturing, experience in taking programs through late-stage development and filing, and ability to make sound technical decisions in a pre-commercial biotech environment.

Work Arrangement & Location

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday . Additional on-site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties and Responsibilities

• Define and execute drug product development strategy for assigned small molecule programs, including formulation approach, manufacturing platform, and the development roadmap required to support the clinical and regulatory plan.
• Lead formulation development activities for small molecule drug candidates across all clinical phases, including excipient screening, compatibility studies, formulation optimization, and selection of final drug product composition for clinical and commercial manufacturing.
• Direct and oversee drug product process development, technical transfer, scale-up, process optimization, registration batch execution, and process validation / PPQ for solid oral dosage forms (tablets, capsules) and other small molecule drug delivery systems.
• Serve as the primary technical interface with CDMO drug product teams for assigned programs, defining the scope of activities, providing scientific oversight of formulation and manufacturing campaigns, document review, and de

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be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Salary Range
$199,000 — $258,000 USD

Benefits

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

• Competitive health and wellness coverage (structure and premiums vary by country)
• Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
• Flexible work arrangements / hybrid schedule

Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.

Equal Employment Opportunity

Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Reasonable Accommodation

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

Privacy

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at Privacy Policy - Beeline Medicines