Technical Operations Manager – SME Sterile Manufacture

• Your mission
• In your role as a Subject Matter Expert (SME) for the transfer of parenteral products, you prepare product-specific risk assessments to evaluate the technical feasibility and implementation at the respective contract manufacturing organisation (CMO).
• You define Critical Material Attributes (CMAs), Critical Quality Attributes (CQAs), and the resulting Critical Process Parameters (CPPs) in accordance with relevant guidelines.
• You play a key role in the preparation of master documentation for product transfers, working closely with our international Regulatory Affairs department.
• You evaluate data and documentation generated during product transfers and derive the necessary GMP-compliant conclusions and corresponding actions.
• Your responsibilities also include supporting the investigation and handling of quality-related deviations during transfers in close collaboration with the Quality department.
• You coordinate commercialisation-related aspects of product transfers with the Supply and Sales department.
• In addition, you provide backup support for the administrative requirements of product transfers, such as purchase order creation and invoice processing, as well as the electronic filing and management of documentation.

Your profile

• You have many years of experience as a Manufacturing or Line Manager, as an Expert in Qualification, Validation or Process, or with comparable qualification in the production environment of sterile medicinal products.
• Knowledge of regulatory documentation (CMC dossier / e CTD Module 3), requirements, and procedures is an advantage.
• You have experience in project management and work in a well-structured, highly diligent, and solution-oriented manner.
• You communicate confidently in both German and English; proficiency in an additional foreign language would be an advantage.
• You are confident in using standard MS Office applications and are familiar with tools such as Copilot.
• You have strong communication and teamwork skills, a commitment to continuous professional development, and the flexibility to spend part of your working time at other locations within the company group.

Why us?

• Comprehensive, industry-specific onboarding and independent work in your field of reaponsibility
• A good work-life balance thanks to flexible working hours and the option of mobile working
• 30 days' vacation and time off in special life situations
• Fair, attractive remuneration as well as a company pension allowance and capital-forming benefits
• Individual training opportunities and support for professional and personal development
• An attractive, modern working environment with ergonomic workstations and the option to lease a job bike
• EGYM Wellpass for a wide range of sports and wellness activities
• Discounts at numerous shops and brands through our corporate benefits
• Bistro offering hot meals and meal subsidies
• Company celebrations, such as family summer parties and annual kick-off events

About us hameln pharma gmbh is a dynamic, successful, medium-sized company specialising in the marketing of generic parenteral drugs.

These are used in the hospital sector in particular, primarily in anaesthesia and intensive care medicine.

We offer our products in over 45 countries worldwide via international networks, affiliates and business partnerships.