Job Description

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About the role:

As a Quality Control Scientist, you will be accountable for life cycle management activities of analytical and microbiological assays performed in the QC Laboratories of Neuchâtel – Switzerland with a focus on laboratory investigations, laboratory method validations and verification, laboratory method transfers, critical material qualification (Reference Standard, Assays Controls and Critical Reagents) and regulatory submissions authoring In addition, the job holder also leads improvement projects, supports complex multi-site Quality Control Scientist supports daily QC activities following cGMP, Takeda policies and EHS requirements.

How you will contribute:

• Author validation or verification protocols and reports for assays
• Author qualification plans and reports for critical reagents and reference standards • Author assignment plans and reports for method controls
• Establish and perform evaluation of control charts • Oversee validation and qualification activities executed by analysts, provide training and support
• Support of analytical method transfers as transferring or receiving unit between Analytical Development and Laboratories as well as within Operations
• Assure cGMP compliant and timely implementation and maintenance of validated status of assays
• Investigate and trouble shoot problems which occur to determine solutions or recommendations for improvements or change
• Conduct/participate in risk assessments, root cause analysis and investigations
• Identify, lead and drive improvements or change
• Serve as SME for internal technical group discussions
• Provide technical assessments on deviations and investigations
• Participate in multi-site projects as local project lead, working in collaboration with other Global Network groups
• Support the application of industry specific compliance standards/regulations to assays life cycle management activities
• Act as local SME for relevant global procedures (e.g. method validation and transfer, control chart trending, handling of investigations)
• Provide hands-on guidance and training when needed • Participate to daily activities upon request (provide technical and statistical support)
• Act as Change Control Assessor and Actions Owner
• Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions
• Support global harmonization and simplification
• Setting up automated charts using the data analytics system to monitor and analyze CQAs
• Performing statistical evaluations of CQAs data to ensure process capability and compliance
• Presenting trends in cross-functional meetings and authoring detailed CPV reports to document findings and recommendations
• Leading investigations for OOT observations or unexpected shifts to maintain product quality
• Participating in the identification and updating of CQAs for the products manufactured
• Providing data for PQRs to ensure ongoing quality assurance and compliance
• Supporting external sites in case of unexpected shifts in CQAs related to on-site lab assays
• Setting and maintaining data analytics/monitoring tools and providing training within QC when necessary
• Provides expert input on project execution and acts as a consultant to management.
• Documents and reviews data and reports as per established company guidelines and SOPs. Authors and reviews/edits documents such as protocols, memos, data summaries, reports and procedures and contributes publications in field of expertise and relevant CMC sections of regulatory filings. Writing requires some revision.
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What you bring to Takeda:

• University or engineering degree in analytical chemistry, biotechnology, biochemistry
• Good skills in microbiology field is a plus
• At least 5 years of experience in GMP pharma business activities, preferably in the scope of recombinant therapeutic product in pharmaceutical environment
• More than 2 years of experience in GMP Laboratory activities
• Proven experience and knowledge in analytical transfer programs, method validation and verification
• Good knowledge of critical reagent qualification
• Experience in problem solving (facilitation and application of DMAIC tools) and deviation management
• Good Knowledge of advanced statistical tools (i.e. hypothesis/relationship testing, control charting, capability, design of experiments, multivariate data analysis)
• Experience with project management and/or leadership enabling cross functional engagement to deliver project goals and timelines
• Strong knowledge of regulatory requirements concerning analytical test methods and licenses
• Experience in dealing with audits/inspections with the FDA, other notified bodies, or Health Authority
• Fluent in French and English (C1 written and spoken) • Proficiency in all aspects of standard IT tools
• Strong project management skills to support project delivery and operational readiness
• A proven ability to lead cross functional teams and deliver on tight timelines • Demonstrate flexible and innovative approach to work
• Excellent collaboration skills and teamwork mindset
• Excellent trouble shooting and problem-solving skills as well as an ability to coach and mentor self-directed teams through complex problems solving
• Ability to challenge the status quo with a continuous improvement mindset
• Ability to work independently in a fast-paced environment
• Ability to manage multiple priorities and know when to escalate issues for resolution
• Effective communicator and strong decision maker
• Proactive at keeping current with literature and latest technologies
• Demonstrated ability to synthesize information and defend conclusions publicly
• Demonstrated ability to give and receive feedback

What Takeda can offer you:

We want our employees to succeed in everything they do – at work, at home, and in the community. This is why we offer world-class benefits and access to resources that can support people.

Our sector and the needs of our patients are constantly changing, which is why we emphasize continuous training. We actively support and invest in the development of our employees through a 50/40/10 training model.

We offer a comprehensive benefits package, prioritizing wellbeing, career growth, and work-life balance:

• Generous Time Off: 28 days of paid.
• Health & Wellbeing: Sport/Fitness abonnement contribution, on site cafeteria, medical annual check-ups starting at age 50, financial support and preventive health care insurance
• support for preventive healthcare.
• Family Support: Paid leave for maternity, paternity, and adoption, along with dedicated spaces for nursing mothers.
• Career Development: Access to a Learning Catalog, language courses, and opportunities for internal and international mobility.
• Transportation & Eco-Benefits: Contributions for public transport, incentives for e-biking, and on-site charging stations for electric vehicles. Regular on-site gardening and massages activities.

Important Considerations:

At Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewellery, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers that may require respiratory protection

More About Us:

With over 650 employees, Takeda Neuchâtel is one of the ten largest employers in the Canton of Neuchâtel, and one of the leading biopharmaceutical production sites in Switzerland. Operating 24 hours a day, 7 days a week, the site employs a wide range of professionals trained in biotechnologies and their application to industrial production. With over twenty nationalities, Takeda Neuchâtel offers an international, diverse and innovative working environment within a company that is firmly rooted in and committed to its local ecosystem.

Takeda Neuchâtel is certified as a Training Company by the Swiss State Secretariat for Economic Affairs. We train young apprentices in a variety of fields, including laboratory quality control, logistics, IT and biopharmaceutical production.

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.

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