Senior / Process Scientist (f/m/d)

8036 Takeda Pharmaceuticals International AG; Lavamünd; Vor Ort; EUR 123.000 - 169.000; Vollzeit

Zusammenfassung

Takeda Pharmaceuticals International AG in Zurich seeks a senior MSAT Vaccines technical process owner to drive DP manufacturing lifecycle, tech transfers, PPQ and risk management. You will serve as primary MSAT SPOC for sites and CMOs, shaping strategies and ensuring compliant, robust processes and reliable patient supply. The role demands leadership across matrix teams and strong data analytics capabilities.

Qualifikationen

• Experience in vaccine/DP manufacturing in GMP environments.
• Experience leading tech transfers, PPQ, CPV, and lifecycle management.
• Led cross-functional technical teams and governance discussions in matrix environments.
• Experience working with CMOs and global manufacturing networks.
• Strong written and verbal technical communication skills.

Aufgaben

• Own technical process understanding across DP processes including CPV and lifecycle management.
• Lead technology transfer, PPQ, NPI, site transfers and lifecycle projects.
• Define project scope, timelines, risks, milestones and deliverables.
• Coordinate activities across Manufacturing, QA, QC, Regulatory, Engineering and Supply Chain.
• Ensure readiness for validation, transfer and commercial manufacturing activities.

Kenntnisse

Scientific judgment

Stakeholder management

Technical writing

Data analytics & AI tools

English fluency

Ausbildung

Bachelors/Masters in chemical engineering or related

PhD an advantage

Jobbeschreibung

Job Description

ABOUT THE ROLE

Join our MSAT Vaccines team as a technical process owner and project leader for vaccine Drug Product manufacturing. In this role, you will shape lifecycle and technology-transfer strategy, lead complex technical decisions across internal sites and CMOs, and translate science, process data, and cross-functional expertise into robust manufacturing performance, compliant execution, and reliable patient supply.

OBJECTIVES / PURPOSE

• Serve as technical process owner for assigned vaccine Drug Product (DP) processes across their lifecycle.
• Lead technology transfers, lifecycle management (LCM), PPQ, site-to-site transfers, and CMO-related initiatives.
• Define process strategies, manage technical risks, and ensure robust process performance, compliance, and supply continuity.
• Act as the primary MSAT technical point of contact for assigned sites, CMOs, and cross‑functional teams.
• Drive scientific decision‑making, process improvements, and successful project execution throughout the product lifecycle.

HOW YOU WILL CONTRIBUTE

Process Ownership & Technical Leadership

• Own technical and scientific understanding of assigned DP processes, including control strategy, process validation, continued process verification (CPV), and lifecycle management.
• Lead technical investigations, root cause analysis, and resolution of complex process issues, deviations, and performance trends.
• Drive process robustness, continuous improvement, and risk‑mitigation activities.

Technical Scope

• Provide scientific leadership across relevant vaccine DP unit operations, including formulation, filling, lyophilization, visual inspection, single‑use systems, aseptic processing, process validation, CPV, and control strategy, as applicable to assigned products.
• Lead or oversee process‑fit and gap assessments, process risk assessments and pFMEA, process characterization, validation rationale, process monitoring, and transfer‑readiness evaluations.
• Use statistical analysis, process data, digital systems, and AI‑enabled tools to strengthen process understanding, identify risk signals, and support lifecycle decisions.

Project Leadership

• Lead technology transfer, PPQ, NPI, line start‑up, site transfer, and lifecycle management projects.
• Define project scope, timelines, risks, milestones, decision points, and technical deliverables.
• Ensure readiness for validation, transfer, and commercial manufacturing activities, including effective knowledge transfer and post‑transfer stabilization.

CMO & Stakeholder Management

• Serve as MSAT technical SPOC for assigned CMOs and manufacturing sites.
• Coordinate technical activities across Manufacturing, QA, QC, Regulatory, Engineering, Supply Chain, project teams, and external partners.
• Lead technical governance, issue resolution, escalation management, and decision preparation.

Documentation & Compliance

• Own or approve process‑related technical documentation, transfer packages, technical reports, CPV strategies, APR inputs, process validation rationale, and regulatory filing support.
• Ensure activities comply with GMP, quality standards, regulatory expectations, and approved governance.

Decision & Autonomy

• Lead technical project and process decisions within approved governance for assigned products, processes, sites, and CMOs.
• Make or recommend decisions on process strategy, process‑fit conclusions, technical risk acceptance, mitigation plans, PPQ and transfer readiness, process‑change direction, documentation strategy, and escalation requirements.
• Escalate decisions with broader portfolio, regulatory, supply, resource, or product‑team impact to the appropriate leadership or governance forum, providing a clear recommendation and scientific rationale.

WHAT YOU BRING TO TAKEDA

Education

• Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Pharmaceutical Sciences, Life Sciences, or a related technical discipline.
• PhD is an advantage.

Significant Experience

• Significant experience in vaccine or sterile Drug Product manufacturing within a GMP environment, with demonstrated accountability for technical process ownership or leadership of complex process‑science workstreams.
• Proven expertise in technology transfer, process validation, PPQ, CPV, process risk management, change control, deviation and CAPA management, and complex process troubleshooting.
• Demonstrated experience leading cross‑functional technical teams and governance discussions in a matrix environment, including decision preparation, influence without direct authority, and structured escalation.
• Experience working with CMOs, external partners, and global manufacturing networks, including technical communication, process‑fit assessment, readiness review, issue resolution, and risk follow‑up.
• Strong track record of leading complex projects across multiple products, sites, partners, or lifecycle stages while balancing quality, regulatory, supply, timeline, and technical‑risk considerations.

Skills

• Strong scientific and technical judgment, structured problem-solving, and risk‑based decision‑making.
• Effective stakeholder management, influencing, communication, and project leadership skills.
• High‑quality technical writing and documentation discipline.
• Proficiency in data analytics, statistical methods, and digital tools; ability to use AI‑enabled tools appropriately to support process understanding and knowledge management.
• Fluent English required; additional languages are an advantage.

ADDITIONAL INFORMATION

• International and domestic travel, typically 20% to 30%, depending on assigned sites, CMOs, and project phase.
• Ability to work in GMP manufacturing environments and gown for cleanroom entry where required.

Empowering our people to shine

At Takeda, we earn the trust of society and our customers through our values of Takeda‑ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential. As a global top employer, we offer exciting career paths, promote innovation, and strive for top performance in everything we do. Takeda fosters an inclusive, collaborative, and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world.

Diversity, Equality, and Inclusion

Takeda is committed to foster diversity, equality, and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age, or disability.

Learn more at takedajobs.com

Locations

Zurich, Switzerland

Base Salary Range:

CHF116,300.00 - CHF159,940.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time