Executive Director, CMC Analytical Development
Beeline Medicines, Boston, MA, United States
Job Summary
The Executive Director, CMC Analytical Development leads the analytical sciences function responsible for the development, qualification, and validation of analytical methods supporting drug substance, drug product, and stability programs for the company's small molecule and biologic portfolios. This leader plays a critical role in establishing the characterization and control strategy for all product candidates and ensuring analytical readiness for IND, Phase 1–3, and NDA/BLA regulatory submissions. As a key member of the CMC leadership team, this individual partners with Process Chemistry, Product Development, Quality, and Regulatory Affairs to embed analytical rigor into every stage of drug development, from lead nomination through product approval.
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.
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
Define and lead the Analytical Development strategy for the company’s portfolio, encompassing method development, method qualification and validation, release testing, characterization, and stability programs for both small molecules and biologics.
Serve as the senior scientific authority on analytical control strategies, setting the framework for specification development, comparability assessments, and regulatory analytical packages.
Oversee the development, transfer, and validation of analytical methods in compliance with ICH Q2, Q6A/Q6B, and relevant USP/EP chapters; ensure analytical methods are robust, reproducible, and fit‑for‑purpose.
Author and review analytical sections of regulatory submissions (IND, IMPD, NDA/BLA), including method descriptions, validation summaries, stability data, and responses analytical questions from regulatory agencies.
Manage and govern relationships with contract analytical laboratories and CDMOs performing analytical testing, method transfer, and stability studies on behalf of the company.
Lead structural and physicochemical characterization programs for drug substance and drug product, integrating state‑of‑the‑art analytical technologies including LC‑MS, NMR, X‑ray crystallography, and emerging modalities.
Establish and oversee the stability program architecture across all clinical programs, ensuring appropriate study designs, storage conditions, and data interpretation aligned with ICH Q1 guidelines.
Partner with Quality Assurance to ensure analytical methods, specifications, and laboratory practices meet GMP expectations; support internal and CDMO audits from an analytical perspective.
Drive analytical innovation by evaluating and implementing advanced analytical tools, PAT technologies, and digital laboratory systems to improve data quality, throughput, and scientific insight.
Provide analytical due diligence and feasibility assessment for in‑licensing candidates, new program nominations, and external partnership evaluations.
Perform other duties and responsibilities as assigned.
Qualifications
Education: Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a closely related discipline.
15+ years of pharmaceutical/biopharmaceutical analytical development experience in pharmaceutical and/or biotechnology industry.
5 years of people management experience.
Comprehensive expertise in analytical method development, qualification, and validation for small molecule APIs and drug products, with working knowledge of biologics characterization (mAbs, fusion proteins, or related modalities).
Extensive experience authoring analytical sections of regulatory filings including INDs, IMPDs, CTAs, and NDA/BLA modules, and responding to agency information requests on analytical method or specification topics.
Proven track record managing contract analytical labs and CDMOs, including method transfer, out‑of‑specification investigation oversight, governance, and quality system integration.
Proficiency with advanced analytical technologies including HPLC, UHPLC, LC‑MS/MS, NMR, Karl Fischer, particle size analysis, and structural characterization platforms; experience with biologics analytics (e.g., SEC, CE, HIC, peptide mapping) is a plus.
Experience designing and managing ICH‑compliant stability programs, including forced degradation, photostability, and long‑term/accelerated stability study design and data interpretation.
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.
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 $284,000 – $304,395 USD (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 may be available based on individual and company performance.)
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).
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.
#J-18808-Ljbffr
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.
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
Define and lead the Analytical Development strategy for the company’s portfolio, encompassing method development, method qualification and validation, release testing, characterization, and stability programs for both small molecules and biologics.
Serve as the senior scientific authority on analytical control strategies, setting the framework for specification development, comparability assessments, and regulatory analytical packages.
Oversee the development, transfer, and validation of analytical methods in compliance with ICH Q2, Q6A/Q6B, and relevant USP/EP chapters; ensure analytical methods are robust, reproducible, and fit‑for‑purpose.
Author and review analytical sections of regulatory submissions (IND, IMPD, NDA/BLA), including method descriptions, validation summaries, stability data, and responses analytical questions from regulatory agencies.
Manage and govern relationships with contract analytical laboratories and CDMOs performing analytical testing, method transfer, and stability studies on behalf of the company.
Lead structural and physicochemical characterization programs for drug substance and drug product, integrating state‑of‑the‑art analytical technologies including LC‑MS, NMR, X‑ray crystallography, and emerging modalities.
Establish and oversee the stability program architecture across all clinical programs, ensuring appropriate study designs, storage conditions, and data interpretation aligned with ICH Q1 guidelines.
Partner with Quality Assurance to ensure analytical methods, specifications, and laboratory practices meet GMP expectations; support internal and CDMO audits from an analytical perspective.
Drive analytical innovation by evaluating and implementing advanced analytical tools, PAT technologies, and digital laboratory systems to improve data quality, throughput, and scientific insight.
Provide analytical due diligence and feasibility assessment for in‑licensing candidates, new program nominations, and external partnership evaluations.
Perform other duties and responsibilities as assigned.
Qualifications
Education: Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a closely related discipline.
15+ years of pharmaceutical/biopharmaceutical analytical development experience in pharmaceutical and/or biotechnology industry.
5 years of people management experience.
Comprehensive expertise in analytical method development, qualification, and validation for small molecule APIs and drug products, with working knowledge of biologics characterization (mAbs, fusion proteins, or related modalities).
Extensive experience authoring analytical sections of regulatory filings including INDs, IMPDs, CTAs, and NDA/BLA modules, and responding to agency information requests on analytical method or specification topics.
Proven track record managing contract analytical labs and CDMOs, including method transfer, out‑of‑specification investigation oversight, governance, and quality system integration.
Proficiency with advanced analytical technologies including HPLC, UHPLC, LC‑MS/MS, NMR, Karl Fischer, particle size analysis, and structural characterization platforms; experience with biologics analytics (e.g., SEC, CE, HIC, peptide mapping) is a plus.
Experience designing and managing ICH‑compliant stability programs, including forced degradation, photostability, and long‑term/accelerated stability study design and data interpretation.
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.
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 $284,000 – $304,395 USD (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 may be available based on individual and company performance.)
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).
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.
#J-18808-Ljbffr