Summary

#LI-Hybrid

As an Associate Director Science & Technology, your main accountability will be to support scientific projects in the clinical phase. You will also have the opportunity to lead and manage global project/network activities, utilizing your scientific, technical, and GMP expertise to address complex Technical R&D challenges. In this role, you will act as a lead scientific advisor, mentor, and coach to other GMP Analytical Experts, driving alignments across different projects and teams. You will actively contribute to shaping the future strategies of our organization by leading global scientific programs and developing long-term strategies on science and technologies.

About the Role

• Leading and managing global AO project teams, networks and/or platforms; handle several activities at a time, while meeting customer needs.
• Provide mentoring and coaching to other Team members / GMP Analytical Experts, driving alignments accross different Projects and Teams
• Act as a recognized GMP Analytical expert in the international scientific community, lead the transfer of knowledge within and across teams, to other departments or external providers
• Shaping and actively driving the future strategy of our organization by leading global scientific programs/initiatives and developing long-term strategies on science and technologies for proactive assurance of compliance and continuous improvements.
• Representing GMP analytical function in a global project analytical sub-team, actively supporting and coordinating the GMP-related analytical activities; enabeling the release of clinical material, conducting stability studies, supporting submissions and implementation, validation and transfer of analytical methods according to GMP standards and agreed project timelines. Assess and consolidate resource needs and timelines for complex projects.
• Write impactful and wide-reaching process-related SOPs or development guidelines, and drive their implementation
• Ensuring compliance of activities with quality standards (GMP), safety standards (HSE) and other Novartis standards

• Technical expert in pharmaceutical technology, biotechnology, biochemistry, chemical engineering or other relevant discipline with PhD and 4 years of relevant working experience or Master of Science with 8 years of relevant working experience in analytical areas in biologic drug development in an industrial setting
• Excellent knowledge and understanding of regulatory expectations and GMP standard and regulations with significant experience with IND/BLA submission
• Provide leadership direction, determination and development of solution approaches by coordinating multiple resources to solve complex analytical problems
• Proven track record of creativity, problem solving, productivity and strong decision making
• Excellent leadership skills with previous working experience in managing teams/projects
• Demonstrated excellent communication, presentation and advanced coaching and mentoring skills
• Proficiency in oral and written English
• Proficient scientific/technical writing skills

• Demonstrated knowledge of Project management and GMP standard and regulations
• Previous experiences working in interdisciplinary teams with excellent theoretical and scientific knowledge of product development

• Vodenje in vodenje globalnih projektnih skupin, omrežij in/ali platform AO; opravljajo več dejavnosti hkrati, hkrati pa izpolnjujejo potrebe strank.
• Zagotavljanje mentorstva in usposabljanja drugim članom ekipe / analitičnim strokovnjakom GMP, spodbujanje usklajevanja med različnimi projekti in skupinami
• Delovati kot priznani strokovnjak za GMP analitiko v mednarodni znanstveni skupnosti, voditi prenos znanja znotraj in med skupinami, drugim oddelkom ali zunanjim ponudnikom
• Oblikovanje in aktivno vodenje prihodnje strategije naše organizacije z vodenjem globalnih znanstvenih programov/pobud in razvojem dolgoročnih strategij o znanosti in tehnologiji za proaktivno zagotavljanje skladnosti in nenehne izboljšave.
• Zastopanje analitične funkcije GMP v globalni analitični podskupini projekta, aktivno podpiranje in usklajevanje analitičnih dejavnosti, povezanih z GMP; omogočanje sproščanja kliničnega materiala, izvajanje študij stabilnosti, podpora predložitev in izvajanju, validacija in prenos analitskih metod v skladu s standardi GMP in dogovorjenimi časovnimi okviri projekta. Ocenite in utrdite potrebe po virih in časovnice za kompleksne projekte.
• Napišite učinkovite in obsežne SOP-je, povezane s procesi, ali razvojne smernice ter spodbujajte njihovo izvajanje
• Zagotavljanje skladnosti dejavnosti s standardi kakovosti (GMP), varnostnimi standardi (HSE) in drugimi standardi NovartisVodi pobude za proaktivno zagotavljanje skladnosti in stalnih izboljšav.

• Tehnični strokovnjak s področja farmacevtske tehnologije, biotehnologije, biokemije, kemijskega inženirstva ali druge ustrezne discipline z doktoratom in 4 leti ustreznih delovnih izkušenj ali magister znanosti z 8 leti ustreznih delovnih izkušenj na analitičnih področjih razvoja bioloških zdravil v industrijskem okolju
• Odlično poznavanje in razumevanje regulativnih pričakovanj ter standardov in predpisov GMP z bogatimi izkušnjami s predložitvijo IND / BLA
• Zagotavljanje vodstvene usmeritve, določanja in razvoja pristopov k rešitvam z usklajevanjem več virov za reševanje kompleksnih analitičnih problemov
• Dokazane izkušnje z ustvarjalnostjo, reševanjem problemov, produktivnostjo in močnim odločanjem
• Odlične vodstvene sposobnosti s predhodnimi delovnimi izkušnjami pri vodenju skupin/projektov
• Izkazal odlične komunikacijske, predstavitvene in napredne veščine coachinga in mentorstva
• Znanje ustne in pisne angleščine
• Usposobljene znanstvene / tehnične pisne spretnosti

• Demonstrirano znanje o vodenju projektov ter standardih in predpisih GMP
• Predhodne izkušnje z delom v interdisciplinarnih skupinah z odličnim teoretičnim in znanstvenim znanjem razvoja izdelkov