Sommario
We are seeking a Senior Manager in Analytical Operations SI (TRD) in Mengeš. In this role, you will be heading and developing young and motivated team of GMP Analytical Experts, who manage scientific projects in clinical phase and are responsible for enabling the release of clinical material, conducting stability studies and actively supporting the tasks of validation, transfer, implementation of analytical methods and preparation of analytical documentation according to GMP standards.
About the Role
Key Responsibilities:
- Leading, coaching, mentoring and managing the team of Analytical Experts with the accountability of the development and motivation of the associates.
- Actively supporting the Training and Learning program of all Project-related activities/roles (including GMP AE on-boarding program/curricula)
- Shaping the strategy of the team among other AO SI teams; connecting and tightly collaborating with the global Analytical Development organization.
- Planning and ensuring capacities within the team, to enable and support our AO core business.
- Promoting quality and assuring all GMP activities are performed in a compliant way and on time.
- Drive and encourage optimization, harmonization, actively promote and run project-related digitalization and automation initiatives within the team and across the TRD organization.
- 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 2 years relevant experience or Master of Science with 6 years of relevant experience
- Experience with analytical lab designs and processes, preferable in an industrial setting (biotechnology) and a solid understanding of Analytical methods, techniques and instruments, as well as knowledge on GMP standard and regulations
- Strong decision making and provide leadership direction, determination and development of solution approaches by coordinating multiple resources to solve complex analytical problems
- Excellent communication, presentation, advanced coaching, mentoring and management skills
- Proficiency in oral and written English.
Desirable Requirements:
- Experience with People management would be an advantage.
- Knowledge of Project management would be highly desirable.
- Knowledge of GMP standard and regulation would be highly desirable.
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 Vodja oddelka Analitskih operacij v Mengešu boste vodili in razvijali mlade in motivirane ekipe analitičnih strokovnjakov GMP, ki vodijo znanstvene projekte v klinični fazi in so odgovorni za omogočanje sproščanja kliničnega materiala, izvajanje študij stabilnosti in aktivno podporo nalogam validacije, prenosa, izvajanja analitskih metod in priprave analitične dokumentacije v skladu s standardi GMP.
Vaše ključne odgovornosti:
- Vodenje, coaching, mentorstvo in vodenje ekipe analitičnih strokovnjakov z odgovornostjo za razvoj in motivacijo sodelavcev.
- Aktivno podpiranje programa usposabljanja in učenja za vse dejavnosti/vloge, povezane s projektom (vključno s programom/učnimi načrti za uvajanje GMP AE)
- oblikovanje strategije ekipe med drugimi ekipami AO SI; povezovanje in tesno sodelovanje z globalno organizacijo za analitični razvoj.
- Načrtovanje in zagotavljanje zmogljivosti znotraj ekipe, ki omogočajo in podpirajo našo osnovno dejavnost AO.
- Spodbujanje kakovosti in zagotavljanje, da se vse dejavnosti GMP izvajajo na skladen način in pravočasno.
- Spodbujati optimizacijo, usklajevanje, aktivno spodbujati in izvajati pobude za digitalizacijo in avtomatizacijo, povezane s projekti, znotraj ekipe in v celotni organizaciji TRD.
- Zagotavljanje skladnosti dejavnosti s standardi kakovosti (GMP), varnostnimi standardi (HSE) in drugimi standardi Novartis
Vaš doprinos k delovnem mestu:
- Tehnični strokovnjak s področja farmacevtske tehnologije, biotehnologije, biokemije, kemijskega inženirstva ali druge ustrezne discipline z doktoratom in 2 leti ustreznih izkušenj ali magisterijem s 6 leti ustreznih izkušenj
- Izkušnje z analitičnimi laboratorijskimi načrti in procesi, po možnosti v industrijskem okolju (biotehnologija) in dobro razumevanje analitičnih metod, tehnik in instrumentov ter poznavanje standardov in predpisov GMP
- Močno odločanje in zagotavljanje vodstvene usmeritve, odločnosti in razvoja pristopov k rešitvam z usklajevanjem več virov za reševanje kompleksnih analitičnih problemov
- Odlične komunikacijske, predstavitvene, napredne coaching, mentorske in vodstvene sposobnosti
- Znanje ustne in pisne angleščine.
Zaželene izkušnje:
- Izkušnje z upravljanjem ljudi bi bile prednost.
- Zaželeno poznavanje projektnega vodenja.
- Zaželeno poznavanje standardov in predpisov GMP.
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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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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.
