Sammanfattning
We are seeking an Associate Director Science & Technology. In this role, you will lead and manage all project/network activities and apply scientific/technical/GMP and/or quality-related expertise to address complex R&D issues; coach senior team members; actively drive line unit strategies by leading cross-functional teams or scientific programs; develop strategies on science and technologies.
About the Role
Key Responsibilities:
- Actively participate in teams, projects, networks and/or platforms; handle several activities at a time, while meeting customer needs.
- Actively contribute to budget and resource forecasts; grant preparation; ensure cost awareness in al assigned projects.
- Interpret results, evaluate data, and draw relevant conclusions; supervise project-related scientific activities; fulfill complex tasks without having established procedures.
- Review and confirm analytical results generated by others; critically evaluate results and challenge conclusions made by other scientists.
- Write impactful and wide-reaching process-related SOPs or development guidelines, and drive their implementation; write scientific reports intended for external partners, and ensure quality of registration documents; interact with authorities where appropriate; act as a technical expert in audits, inspections or due diligences.
- Act as a recognized expert in the international scientific community with excellent leadership skills.
- Ensure compliance with cGMP requirements
- Lead functional sub-teams; represent own function in technical teams, and fulfill all project tasks and responsibilities related to own discipline. Assess and consolidate resource needs and timelines for complex projects.
- Responsibility for personal and professional development.
- Lead initiatives for proactive assurance of compliance and continuous improvements.
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 od 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 boste vodili in upravljali vse projektne/mrežne aktivnosti ter uporabljali strokovno znanstveno/tehnično znanje/poznavanje GMP in/ali strokovno znanje s področja kakovosti za reševanje zahtevnih problemov s področja raziskav in razvoja; usmerjali člane ekipe na višjih delovnih mestih; z vodenjem medfunkcijskih ekip ali znanstvenih programov aktivno vzpodbujali izvajanje linijskih strategij; pripravljali strategije o znanosti in tehnologijah.
Vaše ključne odgovornosti:
- Aktivno sodeluje v ekipah, pri projektih, v mrežah in/ali platformah; obvladuje večje število aktivnosti hkrati;zpolnjuje potrebe kupcev.
- Aktivno prispeva k napovedim proračuna in sredstev ter k pripravi nepovratnih sredstev, zagotavlja ozaveščenost o stroških za vse projekte za katere je odgovoren.
- Tolmači rezultate, vrednoti podatke in dela ustrezne zaključke;nadzoruje znanstvene aktivnosti v zvezi s projekti;izvaja zahtevnejše naloge brez uveljavljenih postopkov.
- Pregleduje in potrjuje rezultate analiz, ki so jih izvajali drugi;kritično ocenjuje rezultate in kritično presoja zaključke drugih znanstvenikov.
- Sestavlja vplivne in dajnosežne splošne postopke ali razvojne smernice za procese ter vzpodbuja njihovo izvajanje; sestavlja znanstvena poročila, namenjena zunanjim partnerjem, ter skrbi za kakovost registracijske dokumentacije;po potrebi sodeluje z ustreznimi organi; deluje kot tehnični ekspert pri presojah, inšpekcijah ali skrbnih pregledih poslovanja.
- Deluje kot priznani ekspert v mednarodni znanstveni skupnosti z odličnimi vodstvenimi sposobnostmi.
- Zagotovite skladnost z zahtevami cGMP
- Vodenje funkcionalnih podskupin; predstavljajo lastno funkcijo v tehničnih ekipah in izpolnjujejo vse projektne naloge in odgovornosti, povezane z lastno disciplino. Ocenite in utrdite potrebe po virih in časovnice za kompleksne projekte.
- Odgovornost za osebni in strokovni razvoj.
- Vodi 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 magisterijem 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 odločanjem
- Odlične vodstvene sposobnosti s predhodnimi delovnimi izkušnjami pri vodenju skupin/projektov
- 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
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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.