- This disposition team is accountable for batch disposition for Biologics product manufactured at CMOs on behalf of Takeda.
- The scope includes Drug Substance, Drug product and Finished Drug Product
- This disposition team will work with our external CMO partners and internal Quality teams within this department .In addition this function works closely with External Supply , Supply Planning, Technical support and any stakeholders involved in external supply.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Reviewing batch documentation, data, certificates of analyses, technical reports and providing guidance and support to Quality Disposition personnel
- Dispositioning batches in alignment with Takeda Quality Systems and GMP regulations
- Leading, designing and implementing quality systems relating to batch disposition
- Leading initiatives that improve processes and quality metrics incorporating continuous improvement methodologies
- Facilitating, approving and providing inputs into deviation investigations, change controls, CAPA, investigations and non-conformance reviews as required
- Leading batch disposition processes as required
- The incumbent should have a strong technical/Quality background with specific experience in Biologics manufacture and batch disposition . Manufacturing site experience would be valuable.The person will have a thorough knowledge of GMPs and Quality Systems
- This person will work in collaboration with the Disposition team , Quality teams and cross functionally with external supply, planning , technical and other stakeholders including CMO partners to disposition batches.
- Good communication and interpersonal skills are required.
- Demonstrates Takeda values in role
Decision-making and Autonomy
- Demonstrated ability to make batch disposition decisions for complex investigations taking into account the available data, regulations and patient safety.
- Demonstrated judgement ability to know when it is appropriate to take decisive action and move efficiently
- Demonstrated strength in cross boundary communication, influencing others
- This person will work in collaboration with the Disposition team , Quality teams and cross functionally with external supply, planning , technical and other stakeholders including CMO partners
- The person will lead continuous improvement initiatives in the batch disposition team and lead/support continuous improvement initiatives in Biologics external supply
- The scope of this role spans Drug Substance, Drug Product, Finished Drug Product manufactured at multiple CMOs across the region
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Minimum of a Bachelors degree plus 12 + years experience working in manufacturing and/or Quality to support the manufacturing of biologic products. Must have experience in batch disposition.
- Thorough understanding of quality systems and cGMPs.
- Experience conducting audits and/or involvement in leading/ coordination of Health Authority inspections.
- Interpersonal skills and communication skills to interact with CMO partners and other functions.
- Must be able to prioritize in a busy environment.
- Must be able to travel up to 30% (domestic and international)
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Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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