CMC Drug Substance Senior Development Leader - Late Stage- Vaccines
Waltham, Massachusetts Permanent Posté le Jan. 02, 2025 Expire le Jan. 17, 2025Job 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 supportthe implementation in future industrial asset accounting for facility fit and industrial assets constraints from starting material to final Drug Product manufacturing.
We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
Main Responsibilities:
Project Leadership and Management
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
Products / Process Industrialization
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.
Tech Transfer (TT) to Industrial Assets (Internal or CMO) as Sending Unit Leader
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
About you
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 thoughlaunch is key; mRNA experience preferred.
Project leadership experience is 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 requirements is highly preferred
Why Choose Us?
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.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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