Analytical Operations EU - Associate Director (Hybrid)

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About the Role

You will have responsibility for testing performed at external service provider (contract test labs and manufacturing organizations; CTLs and CMOs) for small molecule, recombinant biologics and cell therapy products, located within Europe, MENA, and other GEM countries within scope. You will be within Global Small Molecule & Oncology (SM&O) OpU- External Operations EU, Analytical Operations (AO). You will report to the Head Analytical Services Operations.

Accountable for the product testing performance at designated CMOs/ CTLs, to ensure compliance and quality risks are communicated and mitigated, and are an important part of our decisions consistent with relevant standards/ cGMP and Takeda Global Quality Standards.

Accountable for supplier quality management practices to support the outsourced product testing model in the respective region. Influence supplier quality practices to ensure product quality and testing performance.

Primary responsibilities of the position are focused around non-laboratory oversight of the Analytical tasks related to release and stability testing.

How you will contribute:

• Create analytical documentations, e.g. protocols, reports, specifications, and methods
• Directly manage relationships with external testing partners to ensure continuity of testing, investigation and resolution of unexpected results and represent Takeda in interactions with providers
• Be the deviation/Lab investigation owners, support Out Of Specification (OOS)/Atypical laboratory investigations, and provide impact assessment
• Develop and monitor performance metrics, and improve of activities within AO organization
• Lead analytical investigations of unexpected results to identify cause and develop proper corrective or preventive actions
• Manage stability study protocol development, data reporting for OpU products as designated
• Work with the SM&O AO leadership to support the forecast of future spend, monitoring variances, and lead improvements with financial benefit
• Provide support to data analysis, data entry, purchase order creation/reconciliation and financial oversight of third-party labs in Europe and other regions by the third-party lab locations
• Support compliance of testing network through participation in external provider audits, data review and data integrity verification, development of quality agreements and assure execution to requirements
• Support regulatory filing and product APQR
• Identify main trends and new issues at suppliers and implement corrective actions.
• Maintain a broad network of relationships within Takeda’s global environment. Represent Takeda and senior management at corporate and regional meetings and, with Regulatory Agencies, industry groups and partners.
• Delegate for Head of Analytical Operations, External Operations EU.

What you bring to Takeda:

Expected skills

• MSc or PhD in Chemistry, Biology, or related scientific discipline
• 15+ years’ experience in the pharmaceutical and biotech industry R&D, Analytical or QC laboratory environment (in particular biologics)
• Must have in-depth understanding of a variety of analytical techniques such as HPLC, dissolution, GC, FTIR, wet chemistry, Mass Spectrometry, and other analytical techniques.
• Experience with global Health Authorities requirements in the GxP regulated area; detailed knowledge of GMP, ICH, and other relevant regulations.
• Must have broad experience in analytical investigations, handling of OOS/OOT investigations.
• Experience in small molecule API, oral solid dosage and biological products
• Experience in analytical laboratory, method execution, qualification and validation of small molecule or biologics assays
• Experience in regulatory support, authoring dossier sections, respond to regulatory inquiries
• Project management experience
• Awareness of financial processes
• Stability programs management experience
• Proficiency in Microsoft tools, especially Excel
• Knowledge of Laboratory Information Systems (LIMS)
• Fluent in written and spoken English.

• #LI-Hybrid

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 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