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NORTHWAY ĮMONIŲ GRUPĖ

HEAD OF MICROBIAL BIOSYNTHESIS PROCESS DEVELOPMENT GROUP

2500-3000 eur/mon. Gross
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Vilnius - NORTHWAY ĮMONIŲ GRUPĖ

Job description

As an experienced manager with expertise in microbial cultivation, you will lead microbial biosynthesis process development group, transfer and develop USP technologies, strategize to improve the original processes, troubleshoot and resolve technical issues, train and review the work of the team.

As a Head of Microbial USP Development Group you will:
  • Lead the microbial USP process development related activities, including commercial and development production technologies, in order to meet goals and objectives;
  • Ensure the group is supported by experienced staff to control and assure the performance of biosynthesis processes;
  • 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;
  • Identify new approaches, systems to improve quality and productivity;
  • Empower team to ensure ability to manage the day-to-day activities;
  • Review and analyze product quality testing results evaluating the biosynthesis process impact on product quality and its compliance to pre-determined product specification;
  • Evaluate gaps for bringing new technologies, equipment and microbial producer lines to the lab;
  • Write protocols, review data and write final reports, review documentation prepared by the team;
  • Provide regular weekly (or more frequent if required) updates on progress to direct manager;
  • Participate in TCs with different clients representing the progress related with USP development activities;
  • Provide assistance to management in investigations for OOS conditions.

Requirements

  • Science field degree (Master’s degree or PhD in microbiology, cell biology, molecular biology or related sciences preferred);
  • A minimum of 3 years of experience in microbial biosynthesis process development;
  • 5 + years of experience with biologics would be an advantage;
  • Thorough knowledge of microbial cell biology, biosynthesis process design, development and improvement as well as hands-on experience working with different bioreactor systems and related equipment required;
  • Good knowledge of, cGMPs, GLP, FDA guidelines required;
  • Excellent written and verbal communication skills;
  • Good computer skills;
  • Capable of working independently, handling technically difficult projects;
  • Experienced in planning, scheduling, executing and completing projects to meet pre-determined deadlines.

Salary

2500-3000 eur/mon. gross
NORTHWAY ĮMONIŲ GRUPĖ

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.