As an experienced manager with expertise in Analytical methods development and analytical testing, you will lead Analytical methods development group, develop and validate methods, resolve technical issues, provide analytical testing service for process development teams, train and review the work of the team.
As a Manager you will:
As a Manager you will:
- Lead the Analytical methods development laboratory team and related activities, including assays development, testing and qualification for development products, in order to meet goals and objectives
- Ensure the group is supported by experienced staff to control and assure the performance of testing
- Be accountable for the performance and results of unit
- Develop group plans and priorities
- Provide recommendations for efficiency, continuously looking for innovative ways to increase efficiency
- Execute comparability exercises for biologics and generate protocols and reports for that
- Prepare and review SOPs in compliance with regulatory guidelines and applicable principles of GCP/GLP requirements.
- Operate Analytical instruments for biological molecules testing (HPLC, UPLC, LC-MS, SDS-PAGE, cIEF, CE-SDS etc.)
- Prepare bioanalytical methods development and qualification protocols, development and qualification reports.
- Review and implement regulatory guidelines, if applicable
- Evaluate gaps for bringing new technologies and methods to the lab
- Provide assistance to GMP team in investigations of OOS or deviations
- Science field degree
- 3+ years work experience in a Analytical field and biologics
- Thorough knowledge of all areas of testing in a pharmaceutical Analytical laboratory required
- Excellent written and verbal communication skills
- Good computer skills
- Experienced in team management
- Capable of working independently, handling technically difficult projects
- Experienced in planning, scheduling, executing and completing projects to meet deadlines.
- Ability to work under tight schedule and in multitasking environment
3000-5000 eur/mon. gross
NORTHWAY ĮMONIŲ GRUPĖ
Northway Biotech is a leading Contract Development and Manufacturing Organization (CDMO) located in Vilnius, Lithuania, EU and Waltham, MA, USA. Extensive expertise in drug substance and drug product development, as well as GMP compliant manufacturing, makes us exceptionally well-versed in all aspects of the biopharmaceutical value chain – from gene to drug manufacturing in microbial and mammalian expressions systems. Our customers appreciate our ability to react rapidly to unexpected project changes, adjusting timelines, and availability of additional capabilities to meet our customers' evolving needs. We are deeply invested in providing high-quality, world-class contract development and manufacturing services with vast flexibility and responsiveness backed by a strong foundation in science and technology innovation.