Alvotech hf
Alvotech hf
Alvotech hf

Aseptic Processing Team Lead

Alvotech in Reykjavik is looking for an individual to join the Drug Product Manufacturing (DPM) team as a Team Leader. Alvotech operates in a highly regulated environment that requires attention to detail and thoroughness. We are looking for an individual who has strong leadership skills, a positive attitude, embraces challenges, and is flexible and adaptive.

Helstu verkefni og ábyrgð
  • Be responsible for leading and coordinating team of operators to complete manufacturing activities in a safe and cGMP/EHS/Regulatory compliant manner.
  • Perform and oversee cGMP activities within DPM production areas (Grade A, B, C and CNC).
  • Lead the manufacturing team in such a way that both as individuals and as a team, they are engaged, motivated, enabled and empowered to achieve the DP manufacturing schedule.
  • To be a Subject Matter Expert and key team member contributing to successful commercial Pre-Approval Inspections (PAIs), regular audits and any other interaction with regulatory agencies as required.
  • Be an SME author/reviewer and/or approver for written procedures, SOPs etc.
  • By proactive interaction with other departments (e.g. Engineering, Facilities & EHS), be accountable for ensuring the DP manufacturing area and equipment is maintained in a state of inspection readiness.
Menntunar- og hæfniskröfur
  • 5+ years in (bio)pharmaceuticals is required.
  • Education: BSc or Diploma in a Technical Discipline (e.g., biotechnology, engineering, biochemistry or related field) is advantage but not a requirement.
  • Knowledge of Good Manufacturing Practices (GMP), documentation rules, and an ability to follow the documentation for the execution of batch records, SOPs and work instructions is required.
  • Be highly motivated and enjoy keeping a team motivated to complete operations activities in timely manner.
  • Proficient English skills are a requirement (Icelandic is not required).
Auglýsing birt12. febrúar 2024
Umsóknarfrestur3. mars 2024
Tungumálahæfni
Engar sérstakar tungumálakröfur
Staðsetning
Sæmundargata 15-19 15R, 101 Reykjavík
Starfstegund
Starfsgreinar
Starfsmerkingar