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- Salary $100 - $150/hr
- LocationLexington, Massachusetts
- Employment type Contract
- Discipline
- Job descriptionSummary We are seeking an experienced CMC professional to lead Drug Substance and Drug Product stability programs while also contributing to the authoring of high-quality CMC documentation for global regulatory submissions (IND, IMPD, CTA). This hybrid role combines deep CMC operational responsibility—focused on stability, specifications, and analytical documentation—with technical writing expertise to ensure clear, accurate, and compliant regulatory content. The ideal candidate has extensive experience in a cGMP/CMC environment and is comfortable working cross-functionally with Process Development, Analytical, Manufacturing, QA, and external partners. Key Responsibilities (CMC-Focused – ~80%) Stability Program Leadership Lead end-to-end management of Drug Substance and Drug Product stability programs for internally and externally manufactured material. Oversee stability set-downs, pulls, sample submissions to QC, study termination, and stability sample management. Prepare and approve stability protocols, stability summary reports, and regulatory stability sections. Initiate and justify expiry/retest date extensions based on trending and available data. Maintain alignment with Program Team/Corporate timelines and communicate risks proactively. CMC Coordination & Cross-Functional Leadership Host routine stability meetings and analytical strategy meetings with cross-functional stakeholders. Convene ad-hoc working sessions to mitigate supply chain and analytical risks. Partner closely with Analytical Development, QC, Process Development, Manufacturing, QA, Clinical Supply, and external CDMOs. Assist in external analytical laboratory selection, oversight, and ongoing performance management. Specifications, Analytical & Clinical Supply Support Author, review, and manage drug substance and drug product specification justifications, specification tables, and product specifications. Review and approve clinical supply documentation (batch records, labeling, processes) to ensure compliance with cGMP and relevant SOPs. Investigate temperature excursions and quality incidents arising during storage or distribution. SOPs & Quality Systems Generate, review, and approve CMC-related SOPs. Maintain compliance with FDA, EMA, and ICH guidance applicable to clinical-stage development. Technical Writing Responsibilities (~20%) Prepare, write, and review CMC sections of global regulatory submissions (INDs, IMPDs, CTAs), including Module 3 of the CTD. Translate complex technical content—process development history, analytical methods, method validation data, comparability protocols, and stability results—into clear, cohesive regulatory narratives. Draft stability summaries and data-driven tables (batch analysis tables, specification tables) using CoAs and internal specifications. Work within Veeva Vault (or similar systems) for document authoring, version control, and submission readiness. Support responses to Health Authority questions related to CMC and stability topics. Qualifications BS/MS/PhD in Chemistry, Biochemistry, or related scientific discipline. 10+ years of biotechnology/pharmaceutical CMC and cGMP experience. Strong expertise in stability programs, analytical data interpretation, and regulatory CMC documentation. Experience with nucleic acid chemistry or oligonucleotides preferred. Demonstrated ability to work cross-functionally and manage external partners. Exceptional attention to detail, organizational skills, and ability to manage multiple priorities. Strong scientific writing, data interpretation, and communication skills. Summary We are seeking an experienced CMC professional to lead Drug Substance and Drug Product stability programs while also contributing to the authoring of high-quality CMC documentation for global regulatory submissions (IND, IMPD, CTA). This hybrid role combines deep CMC operational responsibility—focused on stability, specifications, and analytical documentation—with technical writing expertise to ensure clear, accurate, and compliant regulatory content. The ideal candidate has extensive experience in a cGMP/CMC environment and is comfortable working cross-functionally with Process Development, Analytical, Manufacturing, QA, and external partners. Key Responsibilities (CMC-Focused – ~80%) Stability Program Leadership Lead end-to-end management of Drug Substance and Drug Product stability programs for internally and externally manufactured material. Oversee stability set-downs, pulls, sample submissions to QC, study termination, and stability sample management. Prepare and approve stability protocols, stability summary reports, and regulatory stability sections. Initiate and justify expiry/retest date extensions based on trending and available data. Maintain alignment with Program Team/Corporate timelines and communicate risks proactively. CMC Coordination & Cross-Functional Leadership Host routine stability meetings and analytical strategy meetings with cross-functional stakeholders. Convene ad-hoc working sessions to mitigate supply chain and analytical risks. Partner closely with Analytical Development, QC, Process Development, Manufacturing, QA, Clinical Supply, and external CDMOs. Assist in external analytical laboratory selection, oversight, and ongoing performance management. Specifications, Analytical & Clinical Supply Support Author, review, and manage drug substance and drug product specification justifications, specification tables, and product specifications. Review and approve clinical supply documentation (batch records, labeling, processes) to ensure compliance with cGMP and relevant SOPs. Investigate temperature excursions and quality incidents arising during storage or distribution. SOPs & Quality Systems Generate, review, and approve CMC-related SOPs. Maintain compliance with FDA, EMA, and ICH guidance applicable to clinical-stage development. Technical Writing Responsibilities (~20%) Prepare, write, and review CMC sections of global regulatory submissions (INDs, IMPDs, CTAs), including Module 3 of the CTD. Translate complex technical content—process development history, analytical methods, method validation data, comparability protocols, and stability results—into clear, cohesive regulatory narratives. Draft stability summaries and data-driven tables (batch analysis tables, specification tables) using CoAs and internal specifications. Work within Veeva Vault (or similar systems) for document authoring, version control, and submission readiness. Support responses to Health Authority questions related to CMC and stability topics. Qualifications BS/MS/PhD in Chemistry, Biochemistry, or related scientific discipline. 10+ years of biotechnology/pharmaceutical CMC and cGMP experience. Strong expertise in stability programs, analytical data interpretation, and regulatory CMC documentation. Experience with nucleic acid chemistry or oligonucleotides preferred. Demonstrated ability to work cross-functionally and manage external partners. Exceptional attention to detail, organizational skills, and ability to manage multiple priorities. Strong scientific writing, data interpretation, and communication skills.