Executive Director, CMC Synthetic Chemistry

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 Executive Director, CMC Synthetic Chemistry leads the drug substance chemistry organization responsible for the design, development, optimization, and scale-up of synthetic routes for small molecule drug candidates. This leader is the primary scientific authority on active pharmaceutical ingredient (API) synthesis, process chemistry, and drug substance manufacturing strategy. Collaborating closely with Medicinal Chemistry, Analytical Development, Product Development, Quality, and external CDMO partners, this leader ensures that safe, scalable, and cost-efficient processes are developed and transferred to support clinical and commercial manufacturing. This role is central to the company's ability to advance its small molecule portfolio with scientific rigor and regulatory readiness.

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.

OR

Remote - This position is designated as remote; the incumbent will be expected to travel to Beeline Medicines’ offices on a periodic basis to support in-person collaboration, team engagement, and business operations. The frequency and scheduling of such visits will be determined at the company's discretion based on business need.

Essential Duties And Responsibilities

• Lead the strategic and operational direction of the CMC Synthetic Chemistry function, overseeing route scouting, process development, process optimization, and scale-up of API synthesis for small molecule programs.
• Define the drug substance process development roadmap for each program, aligning synthetic chemistry deliverables with clinical timelines, CDMO capacity planning, and IND/NDA and global regulatory filing requirements.
• Direct the development of robust, efficient, and scalable synthetic routes suitable for clinical and commercial manufacturing, incorporating green chemistry principles and cost-of-goods considerations.
• Author and review drug substance sections of regulatory submissions (IND, IMPD, NDA/MAA) including process descriptions, control strategies, and synthetic route justifications.
• Select, qualify, and technically govern CDMO partners responsible for API synthesis and drug substance manufacture; serve as the primary technical interface for contract chemistry organizations.
• Oversee process safety assessments, hazard analyses (e.g., HAZOP), and compliance with cGMP expectations for drug substance manufacturing at clinical and commercial scales.
• Establish and implement process analytical technology (PAT) tools and continuous improvement methodologies to enhance efficiency and process understanding.
• Ensure robust intellectual property strategy for synthetic routes and manufacturing processes, partnering closely with IP/Legal to protect proprietary chemistry and manufacturing innovations.
• Drive talent development within the Synthetic Chemistry team; identify capability gaps, hire strategic scientific talent, and build a bench of next-generation process chemistry leaders.
• Contribute to portfolio-level CMC strategy by evaluating drug substance feasibility and manufacturability for in-licensing candidates and new program nominations.
• Perform other duties and responsibilities as assigned
  
  

Qualifications

• Education: Ph.D. in Organic Chemistry, with a specialization in synthetic or process chemistry; or extensive, equivalent industry training
• 15 years of pharmaceutical process chemistry and API development experience
• 5 years of people management experience
• Extensive expertise in synthetic route design, process development, optimization, and scale-up of complex small molecule APIs, including experience with multi-step synthesis and novel chemical entities.
• Demonstrated experience authoring CMC regulatory documents for small molecule drug substances, including IND and NDA modules, and responding to agency questions.
• Deep knowledge of process safety, and cGMP requirements for drug substance manufacturing at clinical and commercial scales.
• Proven ability to select and manage CDMO partnerships for API synthesis, including technical oversight, change control, quality governance, and cost negotiation.
• Proven track record of operating effectively in pre-commercial, resource-constrained environments — balancing strategic vision with hands-on execution and infrastructure building.
• Experience managing cross-functional stakeholder relationships at the executive level, with the ability to influence without authority and align diverse teams around shared program goals.
• Skilled in budget ownership, headcount planning, and CDMO/external partner governance, with a demonstrated ability to deliver on time and within resource constraints.
• Experienced and confident in regulatory agency interactions, including FDA meetings and written responses, with the ability to represent the organization's scientific position with precision and credibility.
• Strong written and verbal communication skills, with a track record of authoring high-quality regulatory documents, scientific reports, and executive-level presentations.
• Collaborative communication style with the ability to establish trust quickly across Research, Clinical, Regulatory, Quality, and external partners in a matrixed organization.
  
  

Salary Range

The expected annual salary range for this position is listed below. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Salary Range

$285,000 - $308,175 USD

Benefits

We offer a comprehensive benefits package including:

• Medical, Dental & Vision insurance (employee premiums 100% covered by company)
• 20 accrued days combined time off (PTO/Sick), 12 company holidays, & winter recharge
• Flexible work arrangements / hybrid schedule
• Health Savings Account (HSA)
• Benefits are subject to eligibility requirements and plan terms. Additional details 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