- The Lead Investigator, part of the Global Manufacturing Sciences organization, provides technical and methodological leadership for complex and/or high impact process/product investigations, following Advanced Problem Solving and 6-sigma methodology.
- In addition, he/she provides methodological and technical support to the internal and external sites/network for large cross-products/cross-sites process improvements, and operational efficiency initiatives related to robustness/yield/efficiency increase across the network.
- Key to this function is to efficiently coach, drive and leverage the dedicated local technical support and global product support teams to achieve their goals.
- Provide technical and methodological leadership for complex and/or high impact process/product investigations.
- Define, deploy and continuously improve a standard problem solving methodology for process investigations. Own the business process and establish the operating mechanisms.
- Drive alignment of best manufacturing practices across Global Manufacturing Sciences and the Operating units taken from investigations or process improvements.
- Stay current with and share across Takeda the industry/academia best practices relevant to biologics, plasma, and small molecules manufacturing
- Implement and maintain a knowledge database for investigation root causes, and pro-actively address vulnerabilities and common causes of issues.
- Designs and analyzes efficient experiments to optimize use of resources to collect information for investigations, validations, and process improvements.
- Support identification and execution of cross-products/cross-sites process improvements
- Drive harmonization, implementation of best practices and knowledge sharing through a community of practice/center of excellence (local PKC coordinators, QbD team)
- Provide technical training to site Manufacturing Sciences organization and other functions (e.g. QC) to ensure high quality of local manufacturing troubleshooting
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Education / Experience
- Minimum of a Bachelors degree in technical / scientific education, preferably biochemistry, biotechnology or pharma - process engineering is essential .
- With a Bachelor's degree, at least 7 years professional experience in a similar role in the field of Technical Operations, Process Management or Development, Manufacturing within the pharmaceutical industry.
- 6-sigma certified (Green or Black-Belt) preferred with demonstrated experience in Technical Problem Solving.
- Prior experience of managing global teams in a matrix is preferred
- Project management, Operational Excellence experience/certification desirable
- Familiarity with data analytics tools
- Strong knowledge of the relevant cGMP, ICH and global Regulatory CMC guidance documents applicable to the function.
- Drives continuous improvement in products and processes
- Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust
- Creating the environment that inspires and enables people
- Focusing on the few priorities and provide superior results
- Elevating capabilities for now and the future
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 OpportunityShire, 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.EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdfEEO is the Law - Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdfPay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdfReasonable AccommodationsShire, 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.