Role Summary
Lead, coordinate, and manage CMC dossier preparation and development processes. Drive alignment between dossier strategy and CMC activities as a core CMC team member, ensuring data supports expedited pathways to clinic and patients. Lead CMC sub team for authoring, review, comment resolution, and approval of CMC dossiers. Ensure timely delivery of CMC dossiers for regulatory submissions and consistency across CMC dossiers and other modules. Contribute to the elaboration/improvement of submission templates and authoring guides, and support M&A licensing due diligence by assessing CMC dossier content. Responsibilities
Lead, coordinate, and manage CMC dossier preparation and development processes. Drive alignment between dossier strategy and CMC activities as a core CMC team member, ensuring data supports expedited pathways to clinic and patients Lead CMC sub team (Dossier Subgroup or Submission Taskforce) for authoring, review, comment resolution, and approval of CMC dossiers Ensure timely delivery of CMC dossier for regulatory submissions (IND/IMPD/CTN/IB/BP, BLA/NDA/MAA/JNDA, Information Requests from Health Authorities). Ensure consistent information presented throughout CMC dossiers and with other modules (e.g., clinical and preclinical) and between CMC dossiers Contribute to the elaboration/improvement of the submission templates and authoring guides in close collaboration with CMC functions, GRA CMC and Digital teams. Support M&A, in licensing due diligence activities by assessing the CMC dossiers content Qualifications
Required: 5 + years of professional experience in CMC development Required: Proven track record in authoring CMC dossiers Required: Understanding of current pharmaceutical environment including digital transformation, economic and regulatory challenges Preferred: Experience with agile/scrum methodologies in pharmaceutical development Preferred: CMC knowledge and experience in Cell/Gene Therapeutics Preferred: Experience with data integration platforms Preferred: Understanding of AI/ML applications in pharmaceutical development Preferred: Knowledge of digital quality management systems and electronic batch records Skills
Knowledge of at least one aspect of CMC development for Biologics: Cell line development, Formulation, DS/DP aseptic manufacturing, Analytical development, and Process and Method validations Comfortable working in digital-first environments with ability to quickly adopt new technologies Understanding of regulatory documents required to support product development milestones, consultation meetings with agency, site inspections, or written responses to Agency’s information requests Knowledge of CMC dossier structures required for clinical trial and market authorization submissions Leadership capabilities: Ability to lead cross-functional teams with internal and/or external partners Strong team spirit with assertiveness: Ability to represent CMC Dossier Sciences and contribute to cross-company projects Facilitator skill to resolve issues and move project forward Agility in priorities, readiness to adopt a TRT culture and embrace continuous digital innovation Proficiency in leveraging digital tools (e.g., Vault RIM, Word and adobe) Education
MS or PHD or an equivalent level degree in life sciences in one of the areas of biopharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biology, biotechnology, biochemistry or related degree) In depth and superior knowledge in pharmaceutical development is mandatory Languages
Excellent oral and written English communication skills
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Lead, coordinate, and manage CMC dossier preparation and development processes. Drive alignment between dossier strategy and CMC activities as a core CMC team member, ensuring data supports expedited pathways to clinic and patients. Lead CMC sub team for authoring, review, comment resolution, and approval of CMC dossiers. Ensure timely delivery of CMC dossiers for regulatory submissions and consistency across CMC dossiers and other modules. Contribute to the elaboration/improvement of submission templates and authoring guides, and support M&A licensing due diligence by assessing CMC dossier content. Responsibilities
Lead, coordinate, and manage CMC dossier preparation and development processes. Drive alignment between dossier strategy and CMC activities as a core CMC team member, ensuring data supports expedited pathways to clinic and patients Lead CMC sub team (Dossier Subgroup or Submission Taskforce) for authoring, review, comment resolution, and approval of CMC dossiers Ensure timely delivery of CMC dossier for regulatory submissions (IND/IMPD/CTN/IB/BP, BLA/NDA/MAA/JNDA, Information Requests from Health Authorities). Ensure consistent information presented throughout CMC dossiers and with other modules (e.g., clinical and preclinical) and between CMC dossiers Contribute to the elaboration/improvement of the submission templates and authoring guides in close collaboration with CMC functions, GRA CMC and Digital teams. Support M&A, in licensing due diligence activities by assessing the CMC dossiers content Qualifications
Required: 5 + years of professional experience in CMC development Required: Proven track record in authoring CMC dossiers Required: Understanding of current pharmaceutical environment including digital transformation, economic and regulatory challenges Preferred: Experience with agile/scrum methodologies in pharmaceutical development Preferred: CMC knowledge and experience in Cell/Gene Therapeutics Preferred: Experience with data integration platforms Preferred: Understanding of AI/ML applications in pharmaceutical development Preferred: Knowledge of digital quality management systems and electronic batch records Skills
Knowledge of at least one aspect of CMC development for Biologics: Cell line development, Formulation, DS/DP aseptic manufacturing, Analytical development, and Process and Method validations Comfortable working in digital-first environments with ability to quickly adopt new technologies Understanding of regulatory documents required to support product development milestones, consultation meetings with agency, site inspections, or written responses to Agency’s information requests Knowledge of CMC dossier structures required for clinical trial and market authorization submissions Leadership capabilities: Ability to lead cross-functional teams with internal and/or external partners Strong team spirit with assertiveness: Ability to represent CMC Dossier Sciences and contribute to cross-company projects Facilitator skill to resolve issues and move project forward Agility in priorities, readiness to adopt a TRT culture and embrace continuous digital innovation Proficiency in leveraging digital tools (e.g., Vault RIM, Word and adobe) Education
MS or PHD or an equivalent level degree in life sciences in one of the areas of biopharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biology, biotechnology, biochemistry or related degree) In depth and superior knowledge in pharmaceutical development is mandatory Languages
Excellent oral and written English communication skills
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