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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 functions works closely with External Supply , Supply Planning, Technical support and any stakeholders involved in external supply.
Reviewing batch documentation, data, certificates of analyses, technical reports and providing support to Quality Disposition personnel
Evaluating, designing and implementing quality systems relating to batch disposition
Maintaining and improving quality metrics that incorporate continuous improvement methodologies
Supporting batch disposition processes as required
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
The incumbent should have a strong technical/Quality background with specific experience in Biologics manufacture. Manufacturing site experience would be Company website person will have a thorough knowledge of GMPs and Quality Systems.
Leadership 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
Evaluation of batch manufacturing records to determine assurances of safety, identity, strength, quality, or purity
On-going evaluation of batch review / release systems to ensure efficient and effective processes are implemented with integrated continuous improvement methodologies
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 support continuous improvement initiatives in Biologics external supply
The scope of this role spans Drug Substance, Drug Product, Finished Drug Product manufactured at mutiple CMOs across the region
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
3 + years’ experience working in manufacturing and/or Quality to support the manufacturing of biologic products.
Thorough understanding of quality systems and cGMPs.
Experience conducting audits and/or involvement in preparation for 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 20% (domestic and international)
Must be fluent in English
Notice to Employment / Recruitment Agents:
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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Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
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