Alvotech hf
Alvotech hf
Alvotech hf

Deildarstjóri Lyfja- og lækningatækjadeildar

Head of Combination Products & Devices (Temporary Position)

Við leitum að hæfum og reyndum einstaklingi til að leiða Lyfja- og lækningatækjadeild hjá Alvotech (e. Combination Products and Devices).

Deildin ber ábyrgð á þróun, prófun, tæknilegri verkefnastjórnun og sér um skráningar í gegnum eftirlitsstofnanir (e. Notified Body), ásamt því að byggja upp og viðhalda skjölum tengdum þróun og framleiðslu í samræmi við reglugerðir. Um er að ræða 18 manna teymi með starfsmönnum víðsvegar að.

Við leitum eftir einstaklingi sem býr yfir vísinda- eða tæknibakgrunni, hefur víðtæka þekkingu á virðiskeðju fyrirtækisins og framúrskarandi leiðtogahæfileika. Viðkomandi mun hafa tækifæri til að leiða og móta þróun háþróaðra líftæknilyfja og tryggja að áfangar tengdir tæknilegri þróun séu uppfylltir samkvæmt tímalínum.

Þetta er tímabundin staða í eitt ár vegna fæðingarorlofs, með möguleika á frekari tækifærum innan Alvotech fyrir réttan umsækjanda.

Við bjóðum upp á skemmtilegt og krefjandi starf í alþjóðlegu umhverfi ásamt fjölbreyttum tækifærum til starfsþróunar. Ef þú hefur áhuga á þessu spennandi tækifæri, hvetjum við þig til að kynna þér það betur á heimasíðunni okkar.

Við hvetjum þig einnig til að skoða starfasíðuna okkar: Join us - Alvotech - Better Access Better Lives sem veitir góða innsýn í vinnustaðamenningu, gildin okkar og það frumkvöðla starf sem við stöndum fyrir.

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Overview of Role

We are seeking a highly skilled and experienced professional to lead our Combination Products & Devices (CPD) team. This role is pivotal in driving and supporting the development of finished product configurations for Alvotech's product pipeline. The ideal candidate will possess extensive knowledge of the enterprise value chain and demonstrate exceptional leadership skills. You will have the opportunity to lead and shape the development of cutting-edge biopharmaceutical products, ensuring milestones related to technical development are met according to agreed timelines, and lead a dynamic and international team of 18 people.

This is a 1-year temporary position to cover for parental leave, with the potential for further opportunities within Alvotech for the right candidate.

Helstu verkefni og ábyrgð
  • Lead the CPD team to ensure milestones related to technical development are met according to agreed timelines. 

  • Oversee design control, human factors, and device-specific risk management for all combination products. 

  • Lead program sub-teams for the development of finished products with the support of a project manager. 

  • Deliver notified body opinions in support of EEA market authorization approval. 

  • Contribute to health authority interactions under the Regulatory Affairs (RA) Lead. 

  • Collaborate with Quality Assurance (QA) and RA for SOP creation where required. 

  • Foster a culture of efficiency and high-quality product delivery. 

  • Accountable for design control project delivery at a senior level and signatory on all Design Development Plan (DDP) versions. 

Menntunar- og hæfniskröfur
  • Minimum MSc Degree in a relevant scientific discipline (Ph.D. is a plus). 

  • Over 10 years of experience in pharmaceutical/biopharmaceutical research and development or industry, with a strong preference for experience related to biosimilars. 

  • Demonstrated scientific and people leadership skills. 

  • Excellent conceptual and analytical problem-solving abilities. 

  • Detail-oriented and well-organized. 

  • Ability to work independently and as part of a team

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 birt16. janúar 2025
Umsóknarfrestur26. janúar 2025
Tungumálahæfni
EnskaEnska
Nauðsyn
Mjög góð
Staðsetning
Sæmundargata 15-19 15R, 101 Reykjavík
Starfstegund
Vinnuumhverfi
Starfsgreinar
Starfsmerkingar