Alvotech hf
Alvotech er fjölþjóðlegt hátæknifyrirtæki í fremstu röð, þar sem yfir 1000 starfsmenn af um 64 þjóðernum vinna að því að móta framtíðina á sviði líftæknilyfja og auka aðgengi sjúklinga um allan heim að hágæða lyfjum. Margir af færustu vísindamönnum landsins starfa hjá fyrirtækinu.
Við leyfum fjölbreytileika, forvitni og frumkvæði starfsfólks að njóta sín. Við bjóðum aðlaðandi starfsumhverfi í stöðugri mótun og ögrandi verkefni. Alvotech tryggir að jafnrétti kynjanna til launa og frama nái til allra starfsmanna, hérlendis jafnt sem erlendis. Við viljum laða að okkur færasta fólkið á hverju sviði, án tillits til uppruna eða kyns. Með þessum hætti getum við best þjónað hagsmunum sjúklinga og samstarfsaðilum okkar.
Vertu með okkur í að bæta lífsgæði fólks og auka aðgengi að hagkvæmum líftæknilyfjum.
Process engineer F&F MSAT
Managing transition of new development processes into late stage-commercial manufacturing. Work as program team representative for technology transfer, validation activities and PPQ. Support external/CMO manufacturing activities.
Helstu verkefni og ábyrgð
- Managing transition of new development processes into late stage-commercial manufacturing by working with PTM and subgroups.
- Work as PTR with PTM and subgroups for technology transfer, validation activities and PPQ.
- Support external/CMO manufacturing activities.
- Responsible for quality documents during the batch (clinical/PPQ/commercial) i.e., process related deviations/change control/CAPA and OOS/OOT/OOR Phase II investigation.
- Be an SME author of Deviations, CAPAs and change controls relating to DPM processes.
- Be an SME author/reviewer and/or approver for written procedures, SOPs, protocols, comparability protocols, sample plan and reports etc.
- Be an SME author for performing risk assessments relating to DPM processes.
- Be an owner for continued process verification (CPV) activities for advanced commercial programs.
- Responsible for addressing the regulatory queries and dossier review for new projects.
- Ability of writing protocols and report the technical information in written and verbal format.
- Basic knowledge of visual inspection guidelines and practices.
Menntunar- og hæfniskröfur
- Education: A minimum of BSc in a technical discipline (e.g., pharmacy, biotechnology, biochemistry, engineering, or a related field) or MSc in a technical discipline (e.g., pharmacy, biotechnology, biochemistry, engineering, or a related field) preferred.
- Experience: A minimum of 5-10 years industry experience in pharmaceutical development and/or manufacturing of finished dosage forms for biopharmaceuticals. Knowledge of GMP, Process Characterization and Validation.
- Skills: Team player with strong leadership and organizational skills. Excellent written and verbal communication skills. Proficient in use of a PC and common Microsoft packages such as Word, Visio, Excel.
Fríðindi í starfi
- An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
- The chance to be a part of a global and fast-growing company.
- An international work culture that encourages diversity, collaboration and inclusion.
- Positive, flexible, and innovative work environment.
- Support for personal growth and internal career development.
- Company social events and milestone celebrations.
- Excellent in-house canteen and coffee house.
- Exercise and wellbeing support for full-time employees.
- On-site shower facility.
- Transportation grant towards eco-friendly modes of travel for full-time employees.
- Internet at home for full-time employees.
Auglýsing birt30. október 2024
Umsóknarfrestur17. nóvember 2024
Tungumálahæfni
Enska
Mjög góðNauðsyn
Staðsetning
Sæmundargata 15-19 15R, 101 Reykjavík
Starfstegund
Starfsgreinar
Starfsmerkingar
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