Senior Analytical Method Lead – Analytical Sciences
About the role:
The Senior Analytical Method Lead will provide strategic cohesive oversight, direction, and leadership to the analytical methods, analytical method transfer, and testing aspects for selected Takeda´s Biologics commercial product portfolio. Also, supply strategic direction through method performance monitoring across sites, analytical method lifecycle management, and method reviews to drive compliance and innovation. This role reports to the Head of Analytical Sciences Biologics (Global Quality).
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 implements 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 for assigned and future products
- Reduce the 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
- 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
- Apply statistical analysis for data interpretation and apply chemometric principles to resolve complex analytical issues and applications
What you bring to Takeda:
- Ph.D. with a minimum of 5 years of industry experience or BS, MS with a minimum of 8 years within the industry
- 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
- 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) - the ability to mentor others in the use of effective methodologies
- Strong verbal & written communication skills, effectively articulate and present complex technical issues concisely to a non-technical audience
- Excellent English language skills
- Some travel is expected: 10%
What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs and company match of charitable contributions
- Family Planning Support
- Professional training and development opportunities
- Tuition reimbursement
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product.
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.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
AUT - Vienna - Kärntner Ring