Your (new) Opportunity:
- Serve as an analytical single point of contact (SPOC) with internal and external stakeholders
- Develop and own analytical method life cycle management (LCM) strategy and process tailored to each commercial Plasma product
- Develop and own process and strategy for analytical method transfer and comparability studies
- Design a rational analytical control strategy and implement analytical risk mitigation plans in accordance with QbD principles
- Provide analytical technical guidance regarding complex analytical issues to internal and external QC labs, and manufacturing sites by Investigating and resolving complex analytical troubleshooting, deviations, and investigation (Rapid Response)
- Reduce number of rapid response incidents by proactively mitigating risks associated with test methods and IPC
- Work cross functionally to continuously improve the process capability and supply chain resiliency for the products within their Plasma portfolio.
- Actively contribute to the preparation of internal audits and regulatory inspections (on-site)
- Create and enhance collaborative and trusting relationships internally and externally
- Build analytical capabilities into local departments as needed
- Provide regulatory support for analytical methods and related aspects
- Participate and represent Takeda in key industry Quality forums (i.e. PQRI)
- Drive innovation and continuous improvement
Your Skills and Qualifications:
- PhD with minimum of 10 years BS/MS with minimum of 15 years of industry experience
- Experienced at leading and delivering successful Technology Transfer activities across the CMO and internal network
- Deep and broad expertise in Analytical Chemistry in support of raw materials, intermediates, drug substances and drug product testing
- Exceptional problem solving and troubleshooting skills related to analytical methodology
- Strong verbal & written communication skills (including presentation skills)
- High level, highly skilled analytical professional with proven ability to influence, negotiate, drive change, and ultimately deliver results
- Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust
- Creating the environment that inspires and enables people
- Full understanding of relevant cGMPs, ICH and other global regulatory CMC guidance documents applicable to the manufacturing and testing of commercial products.
- Some travel is expected (both domestic and international) with varying demand dependent on number and criticality of projects and/or technical issues.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work - life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer.
We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.
Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is € 4.369,11 gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.
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.