Job Title: CMC Drug Substance Senior Development Leader - Late Stage- Vaccines

Location: Waltham, MA

About the Job

As part of the Global Drug Substance Development group within the mRNA Center of Excellence, you as CMC DS Dev sub team leader will represent mRNA DS (from sequence to DS) activities in CMC Project Core Teams and/or CMC Platform teams. In this role you are expected to work independently and to lead a cross-functional DS CMC Sub-team with members from DS Development, Research, Raw Materials, Analytical Sciences, and Manufacturing to deliver DS development work packages from early development through commercialization. You will lead the team to develop and design robust late-stage process and support the implementation in future industrial asset accounting for facility fit and industrial assets constraints from starting material to final Drug Product manufacturing.

• Lead cross-functional CMC DS sub-team(s) and represent CMC Process Development & Industrialization function in CMC project team(s) to enable definition of integrated CMC strategy and responsible for achieving the project objectives.
  

• Provide Reporting on her/his project to Management Provide leadership and direction to the DS / bDP & fDP team to achieve project objectives
  

• Provide consolidated DS development technical work packages with timeline, resource (FTE/budget) and critical path activities to CMC core team for integration into overall CMC project plan. Drives the execution and delivery of quality work packages.
  

• Create optimal conditions for full empowerment of DS sub team members and optimal cooperation with all stakeholders (Research, Manufacturing, Regulatory, Quality).
  

• Maintain effective communication with the related teams
  

• Ensure full synchronization between CMC Team and TT Team.
  

• Lead the team to identify risks, mitigations and communicate to CMC core team. Proactively evaluate and communicate project risks, drive the risk assessment and the development of aligned risk mitigation plans and its implementation with the CMC core team.
  

• Collaborate with Analytical Sciences group to ensure existing platform methods are suitable for new constructs and to develop new, innovative methods as required in support of phase appropriate control strategies (process, raw material, analytical) and comparability strategies
  

• Collaborate with DP development leader to ensure coherence of DS and DP technical strategies
  

• Lead the DS sub-team to ensure that drug substance process development is successfully transferred from development to GMP Manufacturing and process validation. Activities include coordination of GMP batch readiness coordination supported by the GMP Readiness Pathway (GMPRP) approach to secure the pre-requisites delivery on time by their respective owner/contributors.
  

• Contribute to CMC part of the investigational and registration dossiers and responses to agency questions
  

• Contribute to DS manufacturing process platform innovation and engage externally in technical conferences and industry forums to shape platform for manufacturing and control strategies as well as CMC best practices for rapidly evolving mRNA platform
  

• Prepares and communicate complex technical DS topics associated with CMC projects to a variety of stakeholders in mRNA center and outside
  

• Responsible to Product/Process Industrialization in CMC Team for Phase III to transfer to Industrial Team (M&S) for her/his part of Process (Starting Material/ Drug Substance / bulk Drug Product / final Drug Product)
  

• Lead & Coordinate Products / Process Development & Industrialization for Phase III to Industrial Integration : Scale up (Proof Of Technical Feasibility), Process Critical Assessment based QbD approach, Scale Down Model Representativity validation, Robustness Validation based on QbD approach, Technology choices (meet Phase II & Industrial constraints: e.g. Modulus), Comparability report, validation ...
  

• Ensure the convergence between Process Development & Industrialization and mRNA Platform version and Industrial Asset design (Internal or CMO), Support Analytical Methods Development / Products Characterization by developing strong & comprehensive product characterization and analytical package and contribute to CMC part of the Dossier
  

• With CMC Standards SMEs, lead the generation of QbD package with process development teams and other functions to prepare process validation. Be the Drug Substance process Subject Matter Expert and utilize QbD framework to establish robust process and product control strategy.
  

• Support Tech Transfer for Phase III to GMP Manufacturing as Sending Unit Leader for her / his Process part : Responsible to consolidate TT deliverables for Receiving Unit : TT proposal, Knowledge TT Package for her/his Products/Process part, schedule, ...
  

• Contribute to TT Plan including project governance and organization set up, TT strategy,...
  

• Set up organization to support TT
  

• Responsible to gap analysis of Receiving Unit (RU) Process implementation solution and with RU assess and propose solution to bridge gaps or mitigate the risk to ensure product/process comparability
  

• Support C&Q strategy, schedule, validation (VMP contribution,...)
  

• Support C&Q activities: pre-FAT inspections, FAT, SAT, IQ, and OQ of the applicable process, equipment/systems,...
  

• Oversee engineering and consistency lots
  

• Earned Master's degree and 10 years of relevant experience in the pharmaceutical industry, OR earned PhD and 6+ years' relevant experience in pharmaceutical industry
  

• Experience in multi-site-operations and cultures, global projects and matrix management is preferred
  
  
• Experience in Vaccines Drug Substance manufacturing or development is required; Drug Product experience is preferred
  

• A strong relationship builder at all levels both internally and externally if needed for this role. Fluent in English and knowledge of French is strongly preferred.
  
  
• Strong experience in vaccine or biologics process/ product development though launch is key; mRNA experience preferred.
  

• Project leadership experienceis vital to this role
  

• Ability to cooperate transversally / Think strategically / Strive for results / Lead direct and transversal teams
  

• Innovative mind set and ability to develop new technologies and new concepts
  

• Strong knowledge of vaccine processes and cGMPs and regulatory requirementsis highly preferred
  

• Bring the miracles of science to life alongside a supportive, future-focused team.
  
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
  
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.