Technical Project Manager (Fixed Term Contractor)

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Job Description

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.

OBJECTIVES/PURPOSE:

• Manage a transfer of a product portfolio from an internal production site to two CMOs from an overall project and technical manufacturing perspective.

• Transition product manufacturing responsibilities to department stakeholders as divestments are completed and routine commercial manufacturing begins at CMOs.

• Functions as the primary interface between department stakeholders, internal production site, and CMOs related to the project.

• FTC 01.12.2021 – 31.07.2023.

ACCOUNTABILITIES:

• Functions as department representative on the overall project, ensuring key objectives and interests are addressed.

• Manage and update project plan based on latest information.

• Overall oversight of project progress, project governance and steering.

• Coordinate with internal production site, department personnel, and CMOs to ensure project milestones are met.

• Oversight of financial attributes of project – including budget management, change order management, milestone payment plans, invoice review and investments.

• Coordinate and approve purchasing of APIs and materials needed for the Tech Transfer.

• Coordinate with internal production site shipment of production equipment to the CMOs.

• Coordinate and lead regular meetings to review and report project status to department stakeholders.

• Review and approve relevant agreements, project execution plans (PEP), technical transfer, process validation, and stability study documents.

• Align with regulatory team and support completion of regulatory filing variations as needed.

• Collaborative resolution of technical issues encountered at CMOs related to product transfer activities.

• Coordinate and complete change controls in quality system related to product transfers.

• Ensure appropriate handover of activities to department counterparts as product transfers are completed and standard commercial manufacturing activities begin.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Educational Requirements

• Degree in Pharmacy, Chemistry, Biology, Process Engineering or equivalent.

• Certification in project management preferred.

Professional experience

• Minimum five years of experience in project management, production, QA and/or QC within the pharmaceutical industry.

• Good knowledge of regulatory requirements regarding manufacture of medicinal products.

• Knowledge of relevant manufacturing processes and technologies (e.g. BFS, nasal spray, ointments).

• Strong understanding of Supply Chain requirements and setups.

• General understanding of pharmaceutical business (incl. technical pharmaceutical knowledge, regulatory, legal and commercial aspects)

• Knowledge about GMP regulations and requirements.

• Experience in collaboration with contract manufacturing organizations

• Experience in project management tools.

Competences/skills

• Good collaboration skills.

• Organized, results-oriented.

• Structured and able to prioritize tasks.

• Able to solve complex situations and problems.

• Cultural awareness: ability to build good relationships across cultures internally and externally, nationally and internationally.

• Knowledge of GMP, GDP and quality systems.

• Fluency in verbal and written English.

• German proficiency preferable.

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.

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