- Validation subject matter expert to conceive, design and direct the execution of validation/technical shared services projects in support of VBU.
- Support vaccine projects in clinical and commercial production which may involve the development and implementation of comprehensive validation strategies (e.g. validation master planning).
- Author validation deliverables in support of projects, inclusive of the preparation of regulatory filings.
- Establish, support and direct collaborative projects with other VBU functions (e.g. CMC, External Manufacturing, PO, Quality) and External Partners (CMOs) to generate and execute process / product technology transfers and the associated qualification/validation activities.
- Lead process, equipment and ancillary validation activities for multiple projects to develop validation strategies/deliverables for vaccines in clinical/commercial production.
- Effectively manage validation and/or cross functional project teams to promote a culture of team accomplishment and encourage career growth/development.
- Design program and lead teams to execute complex validation activities in support of the production of both current and future clinical/commercial products:
- Extractables & Leachables Program
- Filter Validation Program
- Diluent Production for Dengue (Vial & PFS images)
- Process Control Strategy Standardization
- Deliverables include (and are not limited to): validation/project plans, validation protocols/reports, technical/validation evaluations, risk assessments, control strategies, and regulatory filing sections.
- Analyse, interpret and summarize complex data and contribute to project decisions.
- Propose, establish and lead collaborative projects with other VBU functions and CMO partners.
- In collaboration with External Manufacturing, CMC, PO, and QA design and execute the leachable/extractables program for Dengue and champion the program as a shared service to other programs in both VBU and GMS.
- Partner with internal business partners to provide support for the development and execution of validation activities with the technology transfer of both clinical and commercial products.
- Providing ongoing technical support for process change control, deviation investigations, CAPA management and regulatory filings as required.
- Present project plans, status and results in internal and external meetings.
- Other duties as required.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- MS or PhD and a minimum of 7 years of experience, or BS with a minimum of 10 years clinical/cGMP validation experience for the production of drug substance and drug product for vaccine or biological products.
- Proven ability to design, implement and sustain validation programs for vaccines or biological products. Validation Technologies include: process validation, equipment qualification, and ancillary validation activities (e.g. cleaning validation, sterilization, sanitization, depyrogenation, decontamination, sterile filtration, container closure integrity, shipping, packaging, leachable and extractables, vision inspection, and controlled temperature units).
- Proven ability to work with efficiency across multiple project teams and business functions in a matrix environment. Able to lead and manage technical teams, serve as a partner and influence others.
- Technical management experience, including demonstrated experience managing personnel in a team environment and a working knowledge of project management.
- Significant industry experience and working knowledge of cGMP expectations.
- Seasoned direct interaction /experience with Global Boards of Health during inspections and submissions in support of clinical/commercial production.
- Exemplary oral and written communication skills
- Compliance with Takeda safety practices and standard operating procedures
- Exhibit and promote Takeda Core Competencies.
- As required, comply with institutional certifications and requirements in a cGMP manufacturing and laboratory environment, including associated shipping regulations.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc)
- Type office, laboratory or manufacturing area bending, stooping, lifting requirements apply
- Position requires up to 20% travel (both domestic and international travel required).
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