Associate Director, CMC Analytical Development – Small Molecule

About Beeline Medicines:

Beeline Medicines is a clinicalstage 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 Associate Director CMC Analytical Development Small Molecule is a senior analytical scientist and individual contributor responsible for the development qualification and validation of analytical methods supporting small molecule drug substance and drug product programs. Reporting to the Executive Director CMC Analytical Development this individual serves as the primary technical owner for analytical activities on assigned programs covering method development characterization stability and analytical sections of regulatory submissions. This role carries no direct reports but is the key scientific interface with contract analytical laboratories and CDMO analytical teams. It requires deep expertise in small molecule analytical development and testing a knowledge of GMP laboratory practices and the ability to manage analytical workstreams independently in a pre-commercial fast-moving 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 asTuesday and Wednesday. Additional on-site days may be required based on business needs team priorities or leadership direction.

Essential Duties and Responsibilities:

• Lead the development qualification and validation of analytical methods for small molecule APIs and drug products including assay related substances residual solvents elemental impurities dissolution and physicochemical characterization methods.
• Serve as the primary analytical technical lead for assigned small molecule programs owning the analytical control strategy from early development through IND Phase 13 and NDA regulatory submissions.
• Design and oversee forced degradation studies stress testing and ICH Q1-compliant stability programs for small molecule drug substance and drug product including protocol development data review and shelf-life determination.
• Author and review analytical sections of regulatory submissions including INDs IMPDs and NDA modules and contribute to responses to agency questions on analytical topics with scientific rigor and regulatory awareness.
• Manage method transfer activities to and from contract analytical laboratories and CDMO sites ensuring methods are transferred validated and operationally robust in receiving laboratory.
• Establish and enforce data integrity practices laboratory compliance standards and GMP documentation expectations across the small molecule analytical function in alignment with FDA and ICH guidance.
• Evaluate and implement advanced analytical technologies and instrumentation to improve method sensitivity throughput and scientific insight across small molecule characterization workflows.
• Partner with Process Chemistry and Product Development teams to provide analytical support for manufacturing campaigns including in-process testing impurity profiling and polymorph/salt form characterization.
• Contribute to the development and review of specifications certificates of analysis and release testing strategies for drug substance and drug product in alignment with regulatory expectations and clinical program needs.
• Operate as a self-directed analytical contributor independently managing method development priorities analytical study plans and GMP documentation while proactively communicating progress risks and results to the CMC leadership team and cross-functional partners.
• Perform other duties and responsibilities as assigned

Qualifications:

• Education: Ph.D. in Analytical Chemistry Pharmaceutical Sciences or a closely related discipline preferred; or equivalent industry experience in pharmaceutical analytical development.
• 7 years of pharmaceutical analytical development experience focused on small molecules in pharmaceutical or biotechnology industry.
• Demonstrated track record of serving as the primary analytical lead on drug substance and drug product programs across multiple development phases.
• Deep expertise in small molecule analytical method development and validation using HPLC UHPLC LC-MS GC Karl Fischer dissolution and related techniques in compliance with ICH Q2(R1) and USP/EP requirements.
• Experience authoring analytical sections of INDs IMPDs and NDA filings and responding to FDA or EMA information requests on analytical methods specifications or stability data.
• Proven experience managing method transfer to contract analytical laboratories including transfer protocol development method validation oversight and out-of-specification investigation management.
• Demonstrated experience serving as the primary analytical lead on CMC programs with the ability to set scientific direction prioritize workstreams and drive program accountability without direct reports.
• Skilled in managing external partner relationships including CDMOs and contract laboratories with hands-on experience in technical oversight work order management change control deviation resolution and performance monitoring at the working level.
• Strong written and verbal communication skills with the ability to clearly present scientific data development recommendations and program updates to senior leadership and cross-functional partners.
• Effective collaborator with a track record of building productive working relationships across CMC functions Clinical Development Regulatory Affairs and Quality in a team-oriented environment.
• Organized and detail-oriented communicator who can manage competing priorities proactively flag risks and keep cross-functional stakeholders aligned on timelines and deliverable status.

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 to request an accommodation. We are committed to providing equal access to all candidates.

Privacy

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