Analytical Services Operations Manager

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About The Role

Job Description

You will be responsible of operational, technical and compliance oversight for Global Oncology External Supply Small Molecule (OncESSM) Quality Operating Unit (OpU) Analytical Services Operations (ASO) release and stability testing performed at external service provider (contract test labs and manufacturing organizations; CTLs and CMOs) for small molecule, recombinant biologics and cell therapy products as part of the global ASO function.

Primary responsibilities of the position are focused around non-laboratory support of the Analytical Services tasks related to release and stability testing. Primary activities would generally include but not limited to data analysis, data trending, project and testing coordination, product and material specification management, inspection support, investigation management, operational excellence leads, change control management, document revisions, initiating/completing quality systems, method validation and method projects activities.

How you will contribute

• Create and maintain analytical documentations, e.g. protocols, reports, specifications, and methods
• Directly communicate and managing 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 (AT) laboratory investigations, and provide impact assessment
• Develop and monitor performance metrics, and drive continuous improvement of activities within ASO organization
• Lead analytical investigations of unexpected results to identify root cause and develop proper corrective or preventive actions
• Manage stability study protocol development, data analysis, and reporting for OpU products as designated
• Work with the OncESSM ASO leadership to support the forecast of future spend, monitoring variances, and drive 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

What you bring to Takeda

• MSc or PhD in Chemistry, Biology, or related scientific discipline
• 10+ years experience in the pharmaceutical industry R&D, Analytical or QC laboratory environment
• Must have in-depth understanding of a variety of analytical techniques such as HPLC, dissolution, GC, FTIR, wet chemistry, Mass Spectrometry, NMR and other analytical techniques
• Experience with global Health Authorities requirements in the GMP and GDP 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

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 to 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 information or characteristics, marital status, or any other characteristic protected by law.

What Takeda Can Offer You

• Hybrid mode of working
• 28 working days of vacation per calendar year + 4 floating paid days off set up by our company
• 16 weeks of paid parental leave and possibility of unpaid leave, following the birth or adoption of their child
• Other great benefits including lunch card, transportation contribution, attractive pension plan, and many others.

Locations

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time