Role and Functions:

Acts as Operations representative in NPI (New Product Introduction) projects:

• Represents manufacturing in project planning sessions;
• Ensures all necessary quality standards are met throughout project planning and execution;
• Coordinates activities between R&D and manufacturing groups in Vilnius site;
• Prepares or updates project-specific documentation;
• Prepares or updates QC/manufacturing documents to fit manufacturing and quality needs;
• Prepares or updates stability programs;
• Initiates and manages manufacturing and quality testing activities;
• Is responsible for SKU creation in Agile and/or ERP system;
• Introduces new raw materials to manufacturing, plans and procures them for the first manufacturing;
• Actively indicates risks and escalates them to the core team.

Is responsible for transferring products to manufacturing from other Thermo Fisher Scientific manufacturing sites to Vilnius site:

• Acts as Operations representative: helps in project planning, coordinates activities in manufacturing and quality control teams, reports status of each function;
• If needed acts as a project manager (oversees day to day activities within project, reviews team progress against requirements and plans; resolves deviations, works to develop deliverables, dependencies and resource ;
• Is responsible for product transportation, parameter evaluation, inventory management and overlooks quality assurance for the duration of the project;
• Is responsible for initiating and leading major change procedures:

• Analyzes product specifications, manufacturing processes and procedures to determine best practices to meet or exceed quality requirements;
• Leads changes to processes and ISO procedures as required.

Experience and Essential Skills

• Bachelor’s or Master’s degree in Life Sciences, Biotechnology, or similar disciplines;
• Minimum 1 years of previous administrative experience in a pharmaceutical manufacturing industry;
• Experience in manufacturing processes, development, or R&D is anadvantage;
• Good knowledge of pharmaceutical product development and knowledge of Good Manufacturing Practices (GMP), Standard Operating Procedures (SOP);
• Established quality, regulatory, and production mindset, including a strong appreciation for client service;
• Functions well in a fast-paced, dynamic team environment and also independently with minimal supervision;
• Proficiency with Microsoft Office (Excel, Access, Powerpoint, Visio, Work, Outlook). Superior written, oral, and presentation skills;
• Well organized, enthusiastic, and detail-oriented. Ability to prioritize multiple tasks. Strong interpersonal and communication skills. Excellent team player. Able to work in a fast-paced environment. Demonstrated commitment to our fundamental principles of Integrity, Respect, & Excellence;
• Proficiency with the English language;

The Company offers:

• The innovative environment of the rapidly growing international company;
• High performing, driven and supportive working culture and outstanding development possibilities to increase your potential;
• An exciting opportunity to be part of a dynamic global organization and work with experienced professionals;
• Monthly salary 1800 – 2700 Eur (gross) and additional benefits package.

Call: +370 659 25755