Senior Specialist, Technical Transfer – Small Molecules
Vor 7 Tagen
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, 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 {+ 4 more}
Preferred Skills
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status
Regular
Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Hybrid
Shift
Valid Driving License
Hazardous Material(s)
Job Posting End Date
12/14/2025
- A job posting is effective until PM 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.
Requisition ID
R371158
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