Beeline Medicines

Title: Associate Director, CMC Analytical Development – Small Molecule Location: Boston, Massachusetts, United States; Durham, North Carolina, United States Job Description: 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 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 as Tuesday 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 1–3, 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. 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 $202,000 - $215,604 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. 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

Title: Associate Director, CMC Synthetic Chemistry – Small Molecule Location: Boston, Massachusetts, United States; Durham, North Carolina, United States Job Description: 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 Associate Director, CMC Synthetic Chemistry – Small Molecule is a senior scientific individual contributor responsible for the hands-on development, optimization, and scale-up of synthetic routes for small molecule drug candidates. Reporting to the Executive Director, CMC Synthetic Chemistry, this individual plays a central role in advancing API process chemistry from early development through clinical manufacturing, ensuring that synthetic routes are robust, scalable, safe, and regulatory-ready. This role carries no direct reports but serves as the primary technical owner for assigned programs and is the key scientific interface with CDMO process chemistry partners. It requires deep expertise in organic and process chemistry, direct experience with CDMO technical management, and the ability to operate with scientific independence and collaborative agility 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: - Lead the design, evaluation, and optimization of synthetic routes for small molecule APIs, applying mechanistic understanding and process chemistry principles to develop robust, scalable, and cost-efficient manufacturing processes. - Execute and oversee process development campaigns including reaction optimization, solvent selection, intermediate characterization, and process safety assessments from lab scale through CDMO kilo-lab and pilot plant operations. - Serve as the primary technical interface with CDMO process chemistry teams, providing day-to-day scientific oversight of API synthesis campaigns, reviewing batch records, and driving rapid resolution of process deviations and out-of-specification events. - Author and contribute to drug substance sections of regulatory filings (IND, IMPD, NDA) including synthetic route descriptions, process development summaries, control strategy justifications, and raw material specifications. - Design and execute Design of Experiments (DoE) studies to define process parameters, establish proven acceptable ranges, and support the development of a robust process control strategy in alignment with QbD principles. - Conduct and document process hazard evaluations, reaction safety assessments, and scale-up risk analyses in collaboration with process safety and engineering functions at CDMO partners. - Oversee the sourcing, qualification, and quality assessment of starting materials, reagents, and key intermediates, partnering with Quality and Regulatory Affairs on supplier qualification and control strategy. - Contribute to intellectual property strategy for synthetic routes and manufacturing processes by working closely with IP/Legal to identify patentable innovations. - Operate as a self-directed scientific contributor — managing API route scouting, process development and optimization studies and providing technical oversight of external manufacturing campaigns independently while coordinating effectively with cross-functional and external partners to advance program deliverables on schedule. - Perform other duties and responsibilities as assigned Qualifications: - Education: Ph.D. in Organic Chemistry preferred; or equivalent industry experience in pharmaceutical process development. - 7+ years of API development and process chemistry and experience in pharmaceutical and/or biotechnology industry - Demonstrated track record of serving as the primary scientific lead on synthetic chemistry programs from development through GMP manufacture.. - Deep expertise in synthetic route design and optimization for complex small molecule APIs, including multi-step synthesis, chiral chemistry, and heterocyclic chemistry. - Hands-on experience executing and overseeing API process development campaigns at CDMO sites, including batch record review, technical troubleshooting, and scale-up support. - Proficiency with cGMP expectations for drug substance manufacture. - Experience authoring drug substance sections of INDs, IMPDs, or NDA filings and responding to associated agency questions. - 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. 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 $220,000 - $232,575 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. 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

Title: Senior Director, Bioanalysis Location: Boston, Massachusetts, United States Work Type: Hybrid Job Description: 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: We are seeking an experienced Senior Director, Bioanalysis to lead bioanalytical strategy and execution across small molecule and biologics programs. This role will be responsible for the development, validation, and oversight of bioanalytical assays supporting pharmacokinetics (PK), toxicokinetics (TK), and immunogenicity across preclinical and clinical studies, including Phase 1–3. The ideal candidate will bring deep expertise in bioanalysis together with a familiarity of DMPK and PK interpretation, enabling close partnership across Clinical Pharmacology, Translational Sciences, and Regulatory to support program decisions and regulatory submissions. 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: - Lead bioanalytical strategy across preclinical and clinical-stage programs for small molecules and biologics - Oversee development, qualification, validation, transfer, and lifecycle management of assays for: - Small molecules PK/TK using LC-MS/MS - Biologics PK assay using ligand-binding and/or hybrid assay platforms - Immunogenicity assays, including ADA and neutralizing antibody assessments - Provide scientific oversight for bioanalytical activities supporting preclinical and clinical programs i - Select and manage external bioanalytical partners and ensure high-quality, timely execution - Support investigations and root cause analyses for any out-of-specification (OOS) results, deviations, or process failure - Review and approve assay plans, validation reports, sample analysis plans, data packages, and final study reports - Partner closely with Clinical Pharmacology and translational sciences to support PK/TK interpretation and sampling strategy. - Contribute to study design and execution across preclinical toxicology, clinical pharmacology, and clinical development - Author and review bioanalytical contributions to IND, NDA, and BLA submissions and support responses to health authorities - Ensure bioanalytical activities are conducted in compliance with applicable GLP, GCP, and global regulatory guidance - Perform other duties and responsibilities as assigned Qualifications: - Education: Ph.D. in Bioanalytical Chemistry, Pharmacokinetics, Biochemistry, Pharmaceutical Sciences, or related discipline (or MS with significant relevant industry experience) - 12+ years of relevant experience in bioanalysis supporting drug development within pharmaceutical and/or biotechnology industry - Deep expertise in bioanalysis across preclinical and clinical development - Strong experience with LC-MS/MS assays for small molecules, ligand-binding and/or hybrid assays for biologics, and Immunogenicity assays, including ADA and neutralizing antibody methods - Experience overseeing bioanalytical work across multiple programs and development stages - Strong understanding of regulatory expectations for bioanalytical method validation, sample analysis, and reporting - Experience interpreting PK/TK data and applying bioanalytical results to broader development questions - Experienced in cross-functional collaboration with Clinical Development, Regulatory Affairs, and Translational Medicine teams to integrate clinical pharmacology strategy — including PK/PD, dose selection, and modeling — into program-level decision-making - Demonstrated ability to set strategic direction for clinical pharmacology operations, including study design, data interpretation, and regulatory strategy, while maintaining accountability for quality, compliance, and delivery across competing program priorities - Exceptional ability to synthesize complex PK/PD, exposure-response, and modeling and simulation data and communicate findings clearly to cross-functional audiences ranging from bench scientists to senior R&D leadership, clinical teams, and health authorities - Establishes and models a culture of scientific rigor and open communication within the clinical pharmacology team, ensuring data interpretations, assumptions, and limitations are transparently conveyed and appropriately documented across regulatory and internal deliverables 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 $249,000 - $268,750 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)

Role Description The Director, Regulatory Affairs Operations is accountable for defining and executing the regulatory operations strategy for the organization. This role leads the operational infrastructure, processes, and systems that enable Regulatory Affairs to operate efficiently, compliantly, and at scale in a growing I&I biotechnology company. The Director ensures that global regulatory submissions are strategically planned, executed, tracked, and archived with precision. - Assessment, onboarding, oversight, and performance management of external regulatory operations vendors. - Ownership of the regulatory operations budget, in close partnership with IT, Quality, and the direct manager. - Optimizing the regulatory information management (RIM) ecosystem. - Establishing robust publishing and submission execution frameworks. - Ensuring inspection‑ready archival and traceability across the submission lifecycle. - Developing and implementing regulatory operations processes and training programs to support cross‑functional stakeholders. - Providing ongoing system and user support. - Ensuring cross‑functional alignment on regulatory timelines, milestones, and submission readiness. - Partnering extensively with enterprise functions including Regulatory Strategy, Clinical Development, Preclinical, Quality, Commercial, and IT. - Leading the development of an enterprise regulatory data model that enables seamless data flow, reuse, and traceability across programs and regions. - Building the foundation for a world‑class regulatory function capable of supporting Beeline Medicines’ growth and global ambitions. Qualifications - Bachelor's degree in life sciences, pharmacy, or a related field required; advanced degree preferred. - Minimum of 10 years of regulatory affairs experience in the pharmaceutical or biotech industry. - At least 3 years in a regulatory operations leadership role. - Demonstrated experience managing eCTD submissions and electronic publishing processes, including familiarity with FDA, EMA, and ICH eCTD technical specifications. - Hands-on experience with Regulatory Information Management (RIM) systems such as Veeva Vault Regulatory, PAREXEL's Liquent, InSight, EGNYTE or equivalent platforms. - Thorough knowledge of ICH CTD requirements, FDA 21 CFR Part 11, and applicable regulatory submission standards across clinical development phases. - Proven ability to manage complex submission timelines and cross-functional regulatory deliverables in a matrixed pharmaceutical or biotech environment. - Experience developing regulatory SOPs, training materials, and governance frameworks in compliance with international regulatory requirements. - Familiarity with Trial Master File (TMF) standards (DIA Reference Model) and inspection readiness practices. - Strong regulatory project management skills; experience with regulatory-specific project management tools and timeline visualization platforms is preferred. - Proven track record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building consensus on complex scientific or operational priorities. - Experience navigating organizational ambiguity and change; capable of defining structure, establishing priorities, and scaling functional capabilities in alignment with evolving corporate strategy. - Exceptional written and verbal communication skills with demonstrated ability to translate complex scientific, regulatory, or operational content for diverse audiences, including executive leadership, clinical teams, and external partners. Requirements - Define and lead the Regulatory Affairs Operations strategy, establishing scalable infrastructure, processes, and systems to enable efficient, compliant global Regulatory Affairs execution from IND through post‑approval. - Own end‑to‑end submission planning and execution, ensuring regulatory submissions are planned, built, validated, delivered, tracked, and archived with precision, including eCTD lifecycle management and Health Authority interactions. - Oversee the regulatory information management (RIM) ecosystem and enterprise regulatory data model, enabling seamless data flow, reuse, traceability, inspection readiness, and a complete, accessible, and user‑friendly regulatory archive. - Establish and manage the regulatory submission and publishing operating framework, defining standards for content creation, management, reuse, quality review, and archival across the full submission lifecycle. - Build and manage a high‑performing regulatory vendor ecosystem, defining outsourcing strategies, performing vendor assessment, onboarding, oversight, performance management. - Oversight of the regulatory operations budget ownership in partnership with IT, Quality, and leadership. - Develop regulatory operations processes, training, and user support models, driving adoption, consistency, and effective use of systems and workflows across internal teams and external partners. - Drive operational excellence and executive transparency, establishing KPIs, metrics, and risk management practices; conducting periodic quality assessments of the regulatory management system; and communicating submission readiness, risks, and operational insights to senior leadership. - Perform other duties and responsibilities as assigned. Benefits - 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).

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 Senior Director, Field Medical Affairs leads the strategic direction, operational execution, and performance of the Field Medical team within the Immunology & Inflammation (I&I) therapeutic area. This individual serves as a key scientific and medical leadership partner, responsible for building and sustaining high-impact medical engagement with key opinion leaders (KOLs), academic medical centers, integrated delivery networks (IDNs), and other external experts across the I&I landscape. Reporting to the Executive Director of Medical Affairs, the Senior Director will cultivate a culture of scientific excellence, field intelligence, and cross-functional collaboration, while ensuring all medical activities are conducted in full compliance with applicable regulations, SOPs, and the highest ethical standards. Work Arrangement & Location: Field-Based - This position is field-based, and the incumbent will be expected to work within their assigned territory or region on behalf of the company. Regular travel within the designated geography is an inherent requirement of this role. Additional travel outside of the assigned territory may be required based on business need, including attendance at company meetings, training, or other organizational events. Essential Duties and Responsibilities: - Lead high-quality, non-promotional scientific exchange with international KMEs, clinical investigators, and academic experts across Immunology & Inflammation. - Develop and maintain long-term, credible relationships with global thought leaders and emerging experts in relevant disease areas (e.g., rheumatology, dermatology, gastroenterology). - Represent Medical Affairs at international congresses, advisory boards, and scientific meetings; serve as a credible scientific voice for the organization externally. - Deliver accurate, balanced, and fully compliant communication of clinical, translational, and real-world data in all field interactions. - Architect and own the Global Field Medical Affairs strategic plan across regions, in close partnership with the VP of Medical Affairs and cross-functional leadership. - Provide field-based medical insights that inform clinical development decisions, publication strategy, medical education programming, and product lifecycle planning. - Contribute to the development of scientific platform content, medical FAQs, field tools, and internal training materials. - Ensure scientific rigor and consistency across all global field medical activities as the organization expands geographically. - Support clinical trial site engagement, investigator-initiated research (IIR/IST) identification and feasibility, and real-world evidence initiatives. - Systematically capture, synthesize, and communicate actionable medical insights from the field to internal stakeholders including Clinical Development, Regulatory, and Portfolio Strategy. - Partner with Clinical Development on protocol feasibility assessment, endpoint relevance, and site relationship management. - Define the operational blueprint for the Field Medical Affairs function: territory design, MSL hiring criteria, onboarding curricula, field tools, and CRM/reporting infrastructure. - Lead the recruitment, selection, and onboarding of MSLs as headcount is approved; establish performance frameworks and individual development plans from day one. - Build and continuously refine Medical Affairs processes, standards, and best practices that will scale with the organization. - Serve as the internal champion for field medical as a discipline — educating cross-functional stakeholders on the MSL model and embedding field insights into governance and planning processes. - Partner effectively across Clinical, Regulatory, Safety, and other cross functional stakeholders — wearing multiple hats comfortably in a matrixed biotech environment. - Contribute to advisory board design and execution, medical education programs, and congress strategy. - Perform other duties and responsibilities as assigned Qualifications: - Education: Advanced degree required: PharmD, PhD, DNP, or equivalent in a life sciences discipline. - Minimum of 12 years of progressive experience in Medical Affairs within the biopharmaceutical industry - 5 years in an MSL leadership or field medical management role. - Experience in a biotech or specialty pharmaceutical environment with pipeline assets across multiple development stages. - Strong relationships within the lupus, rheumatology, dermatology, gastroenterology, or related I&I KOL community - Strong therapeutic area expertise in immunology and/or inflammation, including familiarity with autoimmune conditions preferred - Demonstrated track record of building and leading high-performing field medical teams in a national or multi-regional capacity. - Experience supporting a product launch in the I&I space, including pre-launch medical preparation, launch execution, and post-approval evidence generation. - Demonstrated global or international experience, including direct engagement with non-U.S. KMEs and participation in international medical congresses. - Strong understanding of clinical development, late-stage Medical Affairs, and launch-readiness activities. - Deep understanding of the KOL engagement landscape, medical education, evidence generation, and the evolving payer/HEOR environment in I&I. - Strong working knowledge of pharmaceutical compliance requirements, including PhRMA guidelines and applicable federal regulations governing medical-commercial interactions - Experience building, managing or mentoring field medical personnel, with a clear appetite to grow into full team leadership. - Translates complex, domain-specific information into clear and accurate narratives tailored to the knowledge level and needs of the audience. - Approaches interactions as two-way exchanges, drawing out the perspectives and needs of others and converting those signals into actionable input for the organization. - Ability to safely and successfully operate a motor vehicle is required. Valid US Driver’s License and a driving record in compliance with company standards - Position may require domestic and international travel up to 50%+ of time or more including overnight stay driven by business need 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 $275,000—$324,480 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

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 Senior Director, CMC / GMP Quality Assurance is a senior technical and operational leader responsible for providing comprehensive GMP quality oversight across the full chemistry, manufacturing, and controls (CMC) lifecycle for a clinical-stage biotechnology company advancing an immunology and inflammation pipeline, including assets in lupus. This role owns the GMP QA strategy for drug substance and drug product manufacturing activities conducted through a network of contract development and manufacturing organizations (CDMOs), ensuring that all manufacturing processes, analytical methods, batch disposition decisions, and regulatory filings meet the highest standards of quality and compliance. The Senior Director will serve as the primary quality interface between internal CMC Technical Operations and external manufacturing partners, and will play a pivotal role in supporting clinical and commercial readiness milestones. This position requires a seasoned quality leader capable of operating at both strategic and tactical levels, with a track record of driving GMP compliance in complex, multi-modality development environments. Work Arrangement & Location: 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: - Provide strategic and operational GMP quality oversight for all drug substance and drug product manufacturing activities conducted through CDMO partners, encompassing both biologics and small molecule modalities. - Own the batch record review and disposition process, ensuring timely and thorough evaluation of executed batch records, in-process and release testing data, deviations, and investigations prior to Authorized Person or QP release. - Lead quality oversight of CDMO relationships, including execution of technical quality agreements, governance of joint quality meetings, performance monitoring, and escalation of compliance concerns. - Manage and resolve manufacturing deviations, out-of-specification (OOS) results, and out-of-trend (OOT) observations; ensure root cause investigations are scientifically rigorous and CAPA commitments are completed on schedule. - Serve as the primary GMP quality lead for CMC regulatory submissions, including IND amendments, IMPD updates, BLA/MAA modules, and annual product reviews; ensure all CMC documentation accurately reflects current manufacturing and control practices. - Oversee the GMP audit program for manufacturing partners and raw material suppliers, including risk-based audit planning, execution, report issuance, and follow-up on corrective actions to closure. - Collaborate with CMC Technical Operations on process development, technology transfer, scale-up activities, and manufacturing change control to ensure quality is embedded from early development through commercial readiness. - Develop and maintain GMP-related SOPs, quality standards, and technical guidance documents applicable to CDMO-executed manufacturing activities; ensure alignment with evolving regulatory expectations. - Represent CMC Quality in health authority inspections, including pre-approval inspections (PAIs); prepare inspection readiness packages and serve as a subject matter expert for manufacturing and control-related inquiries. - Build, lead, and develop a high-performing CMC QA team; define roles and responsibilities, set performance expectations, and create an environment that prioritizes scientific rigor, compliance integrity, and continuous improvement. - Perform other duties and responsibilities as assigned Qualifications: - Education: Bachelor's degree required in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline; advanced degree (MS, PhD, or PharmD) strongly preferred. - Minimum of 12 years of progressive GMP quality assurance experience in the pharmaceutical or biotechnology industry, - 3 years in a senior leadership capacity overseeing CMC or manufacturing QA functions preferred. - Comprehensive knowledge of global GMP regulations, including FDA 21 CFR Parts 210/211, ICH Q7, Q8, Q9, Q10, Q11, EU GMP Guidelines, and Annex requirements relevant to biologics and small molecule drug development. - Demonstrated expertise in batch record review, disposition decision-making, OOS/OOT investigation oversight, and CAPA management in a GMP-regulated manufacturing environment. - Deep proficiency in CMC regulatory submissions, with direct experience authoring or reviewing IND/IMPD sections, BLA/MAA CMC modules, and responding to health authority information requests related to manufacturing and controls. - Strong technical foundation in both biologics (monoclonal antibodies, fusion proteins, or similar modalities) and small molecule manufacturing processes, analytical method validation, and specification development. - Strategic leader who can prioritize across competing CMC quality demands—balancing inspection readiness, regulatory submission timelines, and CDMO oversight—while maintaining a clear long-term vision for organizational quality maturity. - Proven experience leading or supporting successful FDA and/or EMA GMP inspections, including pre-approval inspections; demonstrated ability to function as a primary quality spokesperson during regulatory agency interactions. - Exceptional written communication skills with demonstrated ability to author and review technically precise regulatory documents, quality agreements, audit reports, deviation investigations, and executive quality summaries. - Strong executive presence and verbal communication skills; able to represent the company's GMP quality posture with credibility and confidence in front of health authorities, CDMO leadership, and internal senior stakeholders. 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 $258,000—$275,000 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