Senior Specialist, Technical Transfer – Small Molecules (m/f/d)

Merck; Unterschleißheim; Hybrid; EUR 85.000 - 110.000; Vollzeit

Zusammenfassung

A leading pharmaceutical company in Unterschleißheim seeks a Senior Specialist (m/f/d) in Technical Transfer. This role involves coordinating sterile drug product transfers, ensuring compliance with regulatory standards. Candidates should have a scientific degree and over 5 years of experience in technical transfer within the pharmaceutical industry. The position offers the opportunity to shape the operations of a newly built facility in a critical investment project.

Leistungen

Flexible work arrangements

Collaboration with global experts

Opportunities for professional growth

Qualifikationen

• 5+ years of experience in technical transfer or manufacturing in pharmaceuticals.
• Familiarity with GMP, regulatory standards, and pharma business processes.
• Business-level English required; German preferred.

Aufgaben

• Support and coordinate technical transfers of sterile drug products.
• Act as a key point of contact for the Unterschleißheim site.
• Monitor and track project timelines and deliverables.

Kenntnisse

Accountability

Adaptability

Business Processes

Quality Assurance (QA) Standards

Regulatory Affairs Compliance

Project Coordination

Pharmaceutical Manufacturing

Ausbildung

Scientific or technical degree

Jobbeschreibung

Job Description

About the role

Our sterile Small Molecule site in Unterschleißheim is one of the key investment projects in our global manufacturing network.

To support the successful start‑up of this facility, we are looking for a Senior Specialist (m/f/d), Technical Transfer – a hands‑on expert who ensures that product transfers are executed efficiently, compliant, and on time.

In this role, you will coordinate and support the transfer of sterile drug products into our new site. You will act as a central interface between global functions (Quality, Regulatory, PTS) and local teams, making sure that technical, regulatory, and operational requirements align.

This position is part of the Small Molecules Technology Transfer Execution organization and will play a critical role in ensuring readiness for commercial operations.

Your Contribution

• Support and coordinate technical transfers of sterile Small Molecule drug products (process and analytical methods)
• Act as a key point of contact between global functions and the Unterschleißheim site
• Monitor and track project timelines, deliverables, and risks – using tools like dashboards and regular reporting
• Collaborate on submission packages and ensure alignment with Regulatory Affairs and Quality
• Work cross‑functionally to ensure smooth handovers and successful implementation of product transfers
• Build strong working relationships with the local site team and understand the priorities and realities on the ground
• Escalate issues when needed – with confidence and clarity
• Bring a mindset of learning and flexibility – including potential exposure to product validation and PTS‑driven projects

What You Bring

• A scientific or technical degree (e.g. in Chemistry, Pharmacy, Biology, Engineering or similar)
• 5+ years of experience in technical transfer, manufacturing, or technical operations in the pharmaceutical industry – preferably with sterile Small Molecule products
• Familiarity with GMP, regulatory standards, and pharma business processes (e.g. change control, deviations, protocols)
• Business‑level English required; German preferred
• Strong project coordination skills – with the ability to keep track of multiple workstreams, deadlines and stakeholders
• A proactive, realistic and resilient mindset – you know when to raise your voice, when to listen, and when to push forward
• Experience working in cross‑functional and international teams
• Readiness to travel (approx. 10‑20%)

What we offer

• A key role in one of our company’s most important investment projects
• The opportunity to work in a newly built sterile facility and shape its operational success
• Collaboration with global experts and local site teams in a highly visible, cross‑functional environment
• A culture that values technical excellence, responsibility, and continuous learning

Why This Role? Why Now?

This is a critical role in one of our most strategic investment projects – and a rare opportunity to shape the success of a new sterile manufacturing site from the ground up. Your work will directly impact product readiness, technical excellence, and the long‑term success of the facility.

You’ll also gain exposure to global functions, diverse project teams, and cutting‑edge operational setups – making this an ideal next step for someone looking to deepen their skills and grow their career within our company.

Interested in shaping something from the start?

Apply now and be part of a team that’s building more than a facility – we’re building the future of manufacturing.

Required Skills

• Accountability
• Adaptability
• Business Processes
• Clinical Supply Chain Management
• Clinical Trial Management
• Feasibility Studies
• Hardware Implementation
• Leadership
• Performance Monitoring
• Pharmaceutical Management
• Pharmaceutical Manufacturing
• Pharmacy Regulation
• Plan of Action and Milestones (POA&M)
• Process Improvements
• Process Operations
• Project Coordination
• Project Planning
• Quality Assurance (QA) Standards
• Real World Evidence (RWE)
• Regulatory Affairs Compliance
• Regulatory Affairs Management
• Regulatory Compliance
• Risk Management
• Self Motivation

Flexible Work Arrangements: Hybrid

Job Posting End Date: 11/11/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.