Associate Director Analytical Sciences

**About the role**:
The Associate Director Analytical Sciences & Biologics will provide strategic cohesive oversight, direction, and leadership to the analytical methods, analytical method transfer, and testing aspects for Takeda´s Biologics commercial product portfolio. He will give strategic direction through method performance monitoring across sites, analytical method lifecycle management and method reviews to drive compliance and innovation.

**How you will contribute**:

- Highly demanding communication and stakeholder management - serve as an analytical single point of contact with internal and external stakeholders per commercial biologics product
- Develop and own analytical method life cycle management (LCM) strategy own process and strategy for analytical method transfer as well as for comparability studies
- Designs a rational analytical control strategy and implement analytical risk mitigation plans in accordance with QbD principles
- Provide analytical evaluation and impact/risk assessment for proposed changes to API, raw materials, manufacturing processes, specifications, and methods.
- Provide analytical technical guidance regarding complex analytical issues to internal and external QC labs, and manufacturing sites for assigned and future products
- 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
- Actively contribute to the preparation of internal audits and regulatory inspections (on-site)
- Provide regulatory support for analytical methods and related aspects, which includes providing analytical submission content strategy, analytical content authoring and review as needed, analytical sections for RtQs and MoH interaction and support
- Participate and represent Takeda in key industry quality forums (i.e. PQRI) to benefit patients by influencing, leading, and collaborating with key academia, industry and regulatory groups
- Provide analytical evaluation and impact/risk assessment for proposed changes to API, raw materials, manufacturing processes, specifications, and methods
- Implement risk mitigation plans proactively for analytical test methods associated with in process control, release, and stability testing

**What you bring to Takeda**:

- PhD with minimum of 10 years of industry experience or BS, MS with minimum of 15 years within industry
- Extensive experience with pharmaceutical pipeline products and CMC aspects of regulatory filings
- Experienced at leading and delivering successful technology transfer activities across the CMO and internal network
- Full understanding of relevant cGMPs, ICH and other global regulatory CMC guidance documents applicable to the manufacturing and testing of commercial products
- Deep and broad expertise in Analytical Chemistry in support of raw materials, intermediates, drug substances and drug product testing
- Highly skilled analytical professional with proven ability to influence, negotiate, drive change, and ultimately deliver results
- Solid problem solving and troubleshooting skills related to analytical methodology (and relevant correlations to manufacturing processes) - ability to mentor others in the use of effective methodologies
- Strong verbal & written communication skills, effectively articulate and present complex technical issues concisely to non-technical audience
- Excellent English and ideally German language skills
- Some travel is expected: 10%

**What Takeda can offer you**:
A competitive remuneration package with a minimum salary of € 4.527,78 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary depends on your professional experience and qualifications.
- Family-friendly company environment; Support with parental leave, dad month, Bilingual company kindergarten
Comprehensive training programs
- In-house job rotation program
- In-house Canteen with discounts or meal vouchers
- Works council (events, festivals, shopping vouchers, etc.)
- Employee Referral Program
- Employee Recognition Program
- Takeda Resource Groups
- Medical checkups
- Free vaccination program
- Fitness Center
- In-house cleaning service

**More about us**:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

**Empowering our people to shine**:
Takeda is proud in its commitment to creating a diverse workforce and