Summary

#LI-Hybrid

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.

• 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

• 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

• 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.

• 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

• 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