Job Description
Analytical Technology Solutions (ATS) supports all animal health sites worldwide in the improvement and validation of analytical methods as well as with all types of analytical investigations. Managing and executing analytical transfer activities and introducing new analytical technologies round out the team's portfolio. Our experts support internal and external operational processes to remain operational, continuously improve, and innovate. With our extensive range of facilities and equipment, our experts have opportunities in many different areas, including biology, chemistry, automation, capital projects, maintenance, safety, process development, technical services, utilities, and validation.
For our Unterschleißheim site, we are looking for a Manager (m/f/d) for Analytical Method Transfers, Method Development, and Validation for our ATS department, effective immediately and limited until September 2030. The position involves leading and implementing analytical transfer activities for active pharmaceutical ingredients (APIs) and finished products (FPUs).
Areas of Responsibility / Tasks:
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Responsibility and leadership as a team lead for a group within the ATS Unterschleißheim department with four employees
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Responsibility for project and resource planning of analytical transfer activities for the Unterschleißheim site in close cooperation with the global ATS Transfer Project Lead and the local PTS for this project
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Independent coordination and execution of transfers, development, validation, and verification of various, sometimes demanding, analytical methods (HPLC, AAS, KF, etc.)
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Integral part of international project teams consisting of project managers, Regulatory Affairs (RA), the transfer technology team, external/internal quality control, and external suppliers
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Responsible for reviewing and evaluating existing methods regarding practical suitability and compliance with EU and US GMP validation requirements, as well as the regulatory status of the method, including further method development and validation if necessary
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Identification of method improvement opportunities with regard to method modernization and/or robustness
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Independent resolution of methodological or device-specific problems, with the ability to access the network of a global player with experts from other laboratories
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Participation in the review and control of laboratory records, plans, and reports of other ATS projects as well as the creation of standard documents
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Creation of analytical documents to prepare for submission to authorities
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Support of multiple analytical transfer activities simultaneously
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Support in troubleshooting in the event of analytical investigations and critical stages during method transfer
Requirements/Competencies:
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Completed degree in natural sciences (e.g., Chemistry, Chemical Engineering, Pharmacy)
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At least 5 years of professional experience in the application, interpretation, and validation of pharmaceutical methods under GMP (e.g., chromatography, spectroscopy, and physico-chemical testing)
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Independent and proactive working style, as well as the ability to make decisions that affect one's own priorities in order to meet timelines
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Project experience in the context of method transfers between global sites
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Experience in matrix-based project or process working methods
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Leadership skills, people coaching
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Excellent team and communication skills, persuasiveness, and assertiveness
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Very good written and spoken German and English skills
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Process understanding and experience in implementing process optimizations
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Experience in the submission process and review of dossiers is an advantage
The stated goal of our Production & Supply division is to act as the world's most reliable manufacturer and supplier of biopharmaceuticals. Together with our external contractors, suppliers, and partners, our production facilities form a tightly woven global production network dedicated to supplying customers and patients with high-quality products reliably and on time in every single case.
We are proud to be a company built on the values of its diverse, talented, and dedicated employees. The fastest way to drive innovative developments is to bring different ideas together in an inclusive environment. We encourage our colleagues to discuss their ideas objectively and to tackle problems together. We see ourselves as an equal opportunity employer and are committed to promoting inclusive, diverse workplaces.
Required Skills:
Adaptability, Analytical Thinking, cGMP Compliance, Chromatography, Interpersonal Relationships, Manufacturing Quality Control, Method Validation, Operational Excellence, People Leadership, Project Management
Preferred Skills:
English Language, German Language
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:
Project Temps (Fixed Term)
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
yes, chemical-physical
Job Posting End Date:
09/24/2026
***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.