Job Description
Summary of Position:
This position ensures that pharma process technology projects are carried out with a consistent approach and on a timely basis in line with the Global AH Quality strategy as well as applicable regulatory requirements.
The position holder is responsible for and should have experience in product qualifications and technology transfer, process improvement, and process validation
The position holder is able to act as a team leader and can be held responsible for the performance and/or start-up of a new and/or difficult process technology assignment.
The manufacturing sites that are supported by the person in this position will include third parties producing AH Pharma products.
The position holder will concentrate his/her activities primarily on the support of Global projects at external manufacturing sites.
Major Assignments:
1. Provide project management and/or technical oversight, planning, coordination and support to drug-product manufacturing sites for projects related to:
i. API-related changes, including supplier and API-process changes
ii. CMO product transfers, including CMO-CMO, site-CMO and R&D-CMO
iii. Process Robustness and Product maintenance (e.g. due to regulatory changes)
iv. life cycle management, technical trouble shooting
v. Process and method validation/qualification
vi. Overarching changes to products or materials.
2. Identification, initiation, support and follow up of projects for continuous improvement of manufacturing processes (process robustness initiative) with target to improve efficacy (e.g. reducing off specs and cycle times, Right First time projects) at the manufacturing sites. Projects include:
i. Stage-gate-process (R&D-to-CMO) for new products (e.g. CMC-section review),
ii. Transfers,
iii. Change control for drug-products (APIs, excipients, packaging),
iv. Contract manufacturing site technical assessments
v. Qualification/validation approaches.
3. Support of direct knowledge transfers involving CMOs, support of development of global key technology platforms, technical expertise and its technology network.
4. Facilitation of communication and interface for manufacturing sites to other global/local departments such as Quality, Supply Chain Management, Regulatory Affairs, Pharma R&D, Global Supplier Management, and CMO Organization.
5. Support or lead investigation teams established to solve major quality issues occurring with our AH pharma products.
Skills:
o Minimum Undergraduate degree in Sciences (Engineering, Manufacturing Technology, Pharmaceutical Technology, or Industrial Chemistry preferred).
o At least 10 years of experience in technology or manufacturing position in a Pharmaceutical, Food manufacturing or Fine chemicals producing company or in extended experience in an academic environment of Pharmaceutical/Chemistry departments.
o At least 5-year Experience in a regulated environment in pharmaceutical CMO management.
o Regulatory background requirements or motivated to acquire this quickly.
o Strong knowledge of GMP requirements or motivated to acquire this quickly.
o Experienced in internal business processes and organization.
o Travel requirement: willing to travel to the different production locations (up to 40 % of the time)
o Language requirements: English (fluent)
Understanding Others - Core
Cross-Functional technical expertise, credibility, innovative- Core
Hiring and Staffing - NA
Team Leadership and Integration - Core
Innovation Management - Advanced
Consulting and Process Re-engineering - Advanced
Managing Diversity - Core
Technical Risk Analysis - Advanced
Directing Others - Core
Supply Chain Knowledge - Awareness
Conflict Management - Advanced
Quality Knowledge - Advanced
Intercultural Management (US, Europe, ROW) - Advanced
Pharmaceutical Technology - Advanced
Regulatory Affairs - Awareness
Required Skills:
Adaptability, Adaptability, API Manufacturing, Business Process Creation, Change Controls, Chemical Engineering, CMO Management, Customer-Focused, Data-Driven Decision Making, Drug Product Development, Equipment Qualification, Estimation and Planning, External Manufacturing, Life Cycle Planning, Manufacturing Quality Control, Manufacturing Technologies, Operations Management, Pharmaceutical Manufacturing, Pharmaceutical Process Development, Process Capability Analysis, Process Control Automation, Process Design, Process Implementations, Process Improvements, Process Maturity {+ 10 more}Preferred Skills:
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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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
09/7/2026*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.
