Zusammenfassung
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
Key Responsibilities:
- 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
Essential Requirements:
- 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
Desirable Requirements:
- 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
We offer permanent employment with 6 months of probation period.
You’ll receive:
Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), employment at Top SI Employer, Unlimited learning and development opportunities.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Kot Znanstveni svetovalec ekspert bo vaša glavna odgovornost podpora znanstvenim projektom v klinični fazi. Imeli boste tudi priložnost voditi in upravljati globalne projektne / mrežne dejavnosti, pri čemer boste uporabili svoje znanstveno, tehnično in GMP strokovno znanje za reševanje kompleksnih tehničnih izzivov raziskav in razvoja. V tej vlogi boste delovali kot vodilni znanstveni svetovalec, mentor in trener drugim analitičnim strokovnjakom GMP, ki bodo spodbujali usklajevanje med različnimi projekti in skupinami. Aktivno boste prispevali k oblikovanju prihodnjih strategij naše organizacije z vodenjem svetovnih znanstvenih programov in razvojem dolgoročnih strategij na področju znanosti in tehnologije.
Vaše ključne odgovornosti:
- 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.
Vaš doprinos k delovnem mestu:
- 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
Zaželene izkušnje:(največ 2 točki sta lahko, opcijsko)
- 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
Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev.
Kaj nudimo:
Konkurenčen plačni paket, letni bonus, fleksibilen način dela, z možnostjo prilagajanja urnika in delom od doma, zaposlitev v podjetju s certifikatom TOP Employer, pokojninsko shemo, shemo nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju telesnega, duševnega in družbenega počutja (Polni življenja) ter dogodke, neomejene priložnosti za učenje in razvoj.
Predani smo raznolikosti in vključenosti
Novartis si prizadeva ustvariti izjemno, vključujoče delovno okolje in oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
