Senior Manager Vaccines MS&T Drug Product (Hybrid)
Takeda
India
Permanent
Full-time
2 months ago
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionObjectiveTakeda Vaccines Business Unit Technical Operations is seeking a highly motivated individual for the role of Manager, Process Technology Drug Product. In this role you will provide technical expertise and leadership for the tetravalent Dengue vaccine formulation and fill-finish activities. Supporting our external and internal manufacturing to remain operational, continuously improve, and innovate you will assume broad responsibility for tech transfer, process qualification and validation at drug product manufacturing sites. Process package transfer, at scale studies, PPQ, process monitoring, and continuous process improvements are key focus areas for the role. Highly level of exposure and interaction to other functional areas supporting late-stage development, product life cycle management and commercial operations in a matrix organization is part of the role assignment.This position is based in India and candidate is expected to be present in person for some Plant activities in Hyderabad.Senior Manager Vaccines MS&T Drug ProductKey Responsibilities:Represent technical operations in cross-functional teams for engineering, qualification and validation of new and existing vaccine manufacturing facilities, processes, technology transfersPartner with cross-functional stakeholders (PM, Development, QC, QA, Supply Chain, Regulatory, etc.) to enable tech transfer, startup of new product lines, scale up and PPQEngage in cross-functional collaboration with global teams to achieve project objectives.Establish effective relationships with all development and manufacturing partners to provide oversight and coordinate with internal teamsConduct technical transfer as well as lifecycle management planning & development from a manufacturing and scientific point of viewProactively anticipate, evaluate, and resolve technical challenges, major deviations, root-cause-analysis, corrective action preventive action (CAPA) and support related change control processes with strong focus on quality, risk mitigation and regulatory complianceEnsure manufacturing processes, facilities, equipment, raw materials and cleaning methods are qualified and where needed validated and maintained in a state of compliance with all GMP and global health regulationsApply risk management principles and methodologies throughout lifecycle management including FMEA, gap analysis, etc.Support writing and review of process manufacturing documentation as well as relevant sections for regulatory submissionsSupport process for management of data and analysis of various operational parameters, including Continuous Process Verification (CPV) and Annual Product Review (APR)Build partnerships in the areas of engineering and process equipment to drive awareness of new technologies for best-in-class manufacturing operationsProvide scientific and technical support of commercial manufacturing at partners to support corporate goals for supply strategiesThis position reports directly to Head of Vaccines Drug Product in SwitzerlandRequirementBachelor degree in life sciences / engineering or in a related area. Advanced degree (MS or PhD) preferredSolid experience tech transfer, and/or sustaining cGMP for drug product processes in manufacturing of biopharmaceuticalsExperience working with vaccines and especially live viruses vaccines is a plusScientific and technical knowledge regarding single use materials, formulation processes, aseptic filling, isolator technology, lyophilization and visual inspectionA self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of structured product developmentProven ability to work with efficiency across multiple project teams and business functions in a matrix environmentAble to lead and manage technical teams, serve as a partner and influence othersDemonstrated cross-functional team experienceFlexibility and the ability to work independently as well as excellent organizational skillsDemonstrated ability to effectively communicate with his team but also at all levels of the organizationsWillingness to travelAbility to maintain discipline on working time management under a hybrid working arrangementExcellent command of English (both written and oral), German language knowledge is a plusLocationsIND - Andhra Pradesh - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
