Job Description Summary
We are seeking Associate Director to lead our Clinical Manufacturing Operations unit in Biocampus, our new Clinical manufacturing facility in TRD Mengeš. Role will be responsible for overseeing compliant manufacturing processes, including production support, material/sample management, HSE, T&L, and infrastructure qualifications. Setting up the required overarching operations and procedures of the plant in close alignment with Drug Substance (DS)and Drug Product (DP) Clinical Manufacturing units and the business needs.
Advertising closing date: 31 August 2024.
Job Description
Responsibilities:
- Responsible for setting and fulfilling the department's objectives, in close collaboration with Drug Substance (DS) and Drug Product (DP) Clinical Manufacturing Units
- Leadership and control of manufacturing operations activities to ensure their quality, timeliness and compliance with the production plans
- Management of the aligned ancillary production support processes and support of process technology for Drug Substance and Drug Product manufacturing
- Support on the introduction of new technologies and techniques, and process optimization
- Coordination of work within the department, setting priorities, and ensuring fulfillment of the department's objectives including the management of resources, responsibility for human resource development, and provision of expertise
- Takes a holistic view, recognizing the interdependencies and interactions between different operational areas and departments from GMP and Development
Requirements:
- University degree in Biotechnology, Pharmacy or related science (advanced degree in scientific or relevant discipline or equivalent preferred).
- 5+ years relevant production experience in the pharmaceutical industry (Aseptics GMP and/or Technical Development), with at least 2 years of managing teams.
- Detailed knowledge of GMP requirements and its applications, industry HSE processes and procedures and a good understanding of risk management and the use of it.
- Good understanding of Development processes of NBEs and NCEs and the relevant interfaces for transfer to Clinical Manufacturing.
- Applications of Lean Manufacturing principles.
- Very good understanding of production equipment and infrastructure; ability to evaluate business opportunities and/or remediate risks jointly with relevant teams.
- Knowledge of (micro-)biology and biotechnology principles.
- Good understanding of material and sample management systems (e.g. SAP, LIMS).
- Knowledge of facility design (e.g. HVAC, cleanliness zoning), cleanroom gowning, personnel and material flows, clean utilities, product change-over (cleaning validation) and EM sampling.
- Excellent project management skills, good communication skills, and a problem-solving mindset with a proactive approach to finding solutions.
- Fluent in written and oral English.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive:
Competitive salary, Annual bonus, Flexible working schedule, 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, Unlimited learning and development opportunities.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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Vodja operacij klinične proizvodnje (m/ž/d)
Kot Vodja operacij klinične proizvodnje (m/ž/d se boste pridružili našemu operativnemu oddelku Klinične proizvodnje v Biokampu. Odgovorni boste za vodenje in nadzor, da proizvodni procei ustrezajo zahtevam. Delovali boste kot podpora proizvodnji, postali boste del HSE, T&L itd. Del vaših nalog bo tudi razvoj in vzpostavljanje operacij in procesov v oddelku s tesnim prilagajanjem skladnosti klinične proizvodnje.
Vaše ključne odgovornosti:
- Odgovorni boste za vzpostavljanje in izpolnjevanje ciljev oddelka, z tesnim sodelovanjem z drugimi oddelki (Drug Product in Drug Substance).
- Vodenje in nadzor operacij proizvodnje, da bi zagotovili kakovostno, pravočasno in skladno delovanje s cilji proizvodnje.
- Vodenje in usklajevanje sorodnih proizvodenj, ki med seboj sodelujejo, za podporo procesom proizvodnje v oddelkih Drug Product in Drug Substance.
- Podpora in pomoč pri uvajanjuj novih tehnologij in tehnik, odgovorni boste za optimizacijo procesov.
- Koordinacija dela znotraj oddelka, postavljanje prioritet, zagotavljanje doseganja zastavljenih ciljev, vodenje resursov in zagotavljanje razvoja človeških virov.
- Vaša naloga bo tudi zagotavljanje, da imate celoten in celosten pogled na delo, da prepoznate nuje in potrebe svojega oddelka in med različnimi operativnimi področji.
Vaš doprinos k delovnem mestu:
- Visokošolska stopnja izobrazbe iz smeri Biotehnologije, Farmacije ali podobne ustrezne smeri.
- Minimalno 5 let izkušenj na področju proizvodnih procesov v farmacevtski industriji in vsaj 2 leti na vodilnih položajih.
- Odlično poznavanje GMP regulativ, HSE in razumevanje procesov s področja upravljanja tveganj.
- Dobro poznavanje razvojnih procesov in infrastructure, sposobnost prepoznavanja poslovnih priložnosti in prepoznati tveganja.
- Poznavanje sistemov za vodenje materialov in vzorcev (SAP, LIMS).
- Odlično poznavanje procesov načrtovanja objektov (HVAC), poznavanje pravli za oblačenje v proizvodnji, vodenje osebja in materialov.
- Odlične sposobnosti vodenja projektov, dobre komunikacijske veščine in motiviranost za reševanje težav.
- Aktivno znanje angleškega jezika.
Prijave z življenjepisom v angleškem in slovenskem jeziku lahko oddate preko spletne povezave.
Zakaj Novartis?
Naš namen je soustvarjati medicino za izboljšanje in podaljševanje življenja ljudi, naša vizija pa je postati najbolj cenjeno in zaupanja vredno farmacevtsko podjetje na svetu. Kako lahko to dosežemo? S pomočjo naših ljudi. Prav naši sodelavci nas vsak dan spodbujajo, da dosežemo svoje ambicije. Postanite del te misije in se nam pridružite! Več na spodnji povezavi: https://www.novartis.com/about/strategy/people-and-culture
Kaj nudimo:
Konkurenčen plačni paket, letni bonus, fleksibilen način dela, z možnostjo prilagajanja urnika in delom od doma, 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.
Pridružite se naši mreži Novartis: V kolikor se ne prepoznate v zgornjem opisu delovnega mesta, vas vabimo, da se vpišete na spodnji povezavi v Novartisovo bazo talentov saj lahko tako vašo vlogo upoštevamo za podobne pozicije v prihodnosti: https://talentnetwork.novartis.com/network
Skills Desired
Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Management, Supply Chain Planning, Technical Requirements, Waterfall Project Management, Wms (Warehouse Management Systems)
