Senior Biotechnologist – Product Manager (148643BR)
- 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.
- Bachelor’s or Master’s degree in Life Sciences, Biotechnology, or similar disciplines.
- Minimum 1 year of previous administrative experience in a pharmaceutical manufacturing industry.
- Experience in manufacturing processes, development, or R&D is an advantage.
- 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. Demonstrated commitment to our fundamental principles of Integrity, Respect, & Excellence.
- Proficiency with the English language.
- 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.
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