- 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, Technical Operations, Manufacturing, Quality) and External Partners (CMOs) to generate and execute process / product technology transfers and the associated qualification/validation activities.
- Ability to lead and/or provide oversight for the delivery of phase-appropriate validation strategies/deliverables for vaccines produced by Takeda or by its CMO partners in support of clinical and commercial objectives. Deliverables include (and are not limited to): validation/project plans, validation protocols/reports, technical/validation evaluations, risk assessments, control strategies, and regulatory filing sections.
- Functional leadership responsibility for the leachable/extractable program in support of VBU products.
- Champion functional programs/initiatives and lead teams which promote continuous improvement and/or bolstering the validation program s technical/compliance posture.
- Effectively manage cross-functional project teams to promote a culture of team accomplishment and encourage career growth/development.
- 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 experience, or BS with a minimum of 10 years clinical/cGMP validation experience to produce drug substance and drug product for vaccine/biological or small molecule products.
- Proven ability to design, implement and sustain validation programs. Demonstrated experience / technical knowledge with process validation is required. Experience with cleaning validation, sterilization, container closure integrity, shipping, leachable and extractables, and vision inspection is highly preferred.
- Proven ability to work with efficiency across multiple project teams and business functions in a globally matrixed environment. Able to lead and manage technical teams, serve as a partner and influence others.
- Seasoned direct interaction /experience with Global Boards of Health during inspections and submissions in support of clinical/commercial production is a plus.
- 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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