Group Head Analytical Development Biosimilars

Job Description
With
over 25 biosimilar assets
currently in development, Sandoz is at the forefront of innovation and development in this field. From the initial stages of research and development to the final submission for regulatory approval, Process Analytical Sciences is involved at every step of the way ensuring the quality and safety of our products.

Join us as
Group Head of Analytical Development (d/f/m)
and become a key contributor to our Sandoz mission of »making access happen« for all patients.

Your Key Responsibilities
Your responsibilities include, but not limited to:

• Management of activities in accordance with biosimilar drug product development strategy, resources, timelines and professional standards.
• Managing the group in accordance with the annual plan (resources / activities / timelines) and targets and assuring group development and personal development (knowledge, skills, values, behaviors).
• Finding innovative solutions in the drug product development of biosimilars.
• Ensuring operational, digital and scientific excellence that is consistent with existing and anticipated trends in the profession and legal regulations.
• Coordinates international teams to deliver drug product projects on time in full.
• Is accountable to present Drug Product related aspects and communicate learnings to top management.
• Coach scientists including identification of roadblocks/risks with the aim to leverage their development and is responsible for collaboration excellence during analytical method transfers.
• Ensuring compliance of activities with standards in the field of quality (GMP), in the field of ensuring health and safety at work and other Sandoz standards.

What You Will Bring To The Role

• Advanced degree (desirable PhD) in life sciences with strong background in biotechnology, biology, biochemistry, analytics, pharmacy, chemistry or other related Life sciences.
• At least 5 years of experience in analytical development and 3 years of leadership experience.
• Solid understanding about quality principles, QbD, GMP, regulatory aspects of pharmaceutical industry.
• Coaching and mentorship experience.
• Excellent understanding of regulatory expectations and requirements and excellent scientific/technical writing skills.
• Experience with working in interdisciplinary and cross-cultural teams.
• Strong soft skills, means the ability to communicate in an open, clear, assertive, organized and concise manner to be influential in scientific meetings and ability to work together as one team in a global environment.
• Scientific Excellence, Digital Excellence and Operational Excellence. Ability to implement new approaches and strives for improvement and simplifications.

You'll Receive
Employment at the most reputable employer in Slovenia offers 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), Unlimited learning and development opportunities.

Possible job locations: Slovenia (Ljubljana)

We offer
permanent contract with 6-month of probation period
.

You are kindly invited to submit your application in English language, including CV, by

Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged

The future is ours to shape

Commitment To Diversity & Inclusion
Sandoz is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.

_____________________________________________________________________________________________________________________________________________________

Sandoz je z
več kot 25 biološko podobnimi zdravili
v razvoju na čelu inovacij in razvoja na tem področju. Od začetnih faz raziskav in razvoja do končne vložitve dokumentacije za regulativno odobritev je procesna analitika vključena v vsak korak, da zagotovi kakovost in varnost naših izdelkov.

Pridružite se nam kot
Vodja skupine za analitski razvoj za podobna biološka zdravila (d/ž/m)
in postanite ključni sodelavec pri naši misiji Sandoza - »omogočiti dostop« vsem bolnikom.

Vaše Ključne Odgovornosti

• Upravljanje dejavnosti v skladu s strategijo razvoja podobnih bioloških zdravil, viri, roki in strokovnimi standardi.
• Upravljanje ekipe v skladu z letnim načrtom (viri/dejavnosti/roki) in cilji ter zagotavljanje osebnega in ekipnega razvoja (znanje, spretnosti, vrednote, vedenje).
• Iskanje inovativnih rešitev pri razvoju podobnih bioloških zdravil.
• Zagotavljanje operativne, digitalne in znanstvene odličnosti, ki bo skladna z obstoječimi in pričakovanimi trendi v stroki ter pravnimi predpisi.
• Odgovornost za predstavljanje vidikov, povezanih z zdravili in najnovejših ugotovitev najvišjemu vodstvu.
• Odgovornost za odličnost sodelovanja pri prenosu analitičnih metod.
• Coaching strokovnjakov, vključno s prepoznavanjem ovir/tveganj, z namenom spodbujanja njihovega razvoja.
• Zagotavljanje skladnosti dejavnosti s standardi na področju kakovosti (GMP), na področju zagotavljanja zdravja in varnosti pri delu ter drugimi Sandozovimi standardi.

Vaš Doprinos k Delovnem Mestu

• Visokošolska izobrazba (zaželen doktorat) na področju naravoslovnih znanosti z dobrim znanjem s področja biotehnologije, biologije, biokemije, analitike, farmacije, kemije ali drugih sorodnih naravoslovnih znanosti.
• Najmanj 5 let izkušenj na področju analitičnega razvoja in 3 leta vodstvenih izkušenj.
• Dobro razumevanje načel kakovosti, QbD, GMP, regulativnih vidikov farmacevtske industrije.
• Izkušnje na področju coachinga in mentorstva.
• Odlično poznavanje regulativnih pričakovanj in zahtev in odlične sposobnosti znanstvenega/tehničnega pisanja.
• Izkušnje z delom v interdisciplinarnih in medkulturnih ekipah.
• Dobre mehke veščine, kar pomeni sposobnost odprtega, jasnega, odločnega, organiziranega in jedrnatega komuniciranja, ki omogoča vpliv na strokovnih srečanjih, ter sposobnost sodelovanja kot samostojna enota med ekipami v globalnem okolju.
• Znanstvena odličnost, digitalna odličnost in operativna odličnost. Sposobnost uvajanja novih pristopov ter prizadevanje za izboljšave in poenostavitve.

Kaj Nudimo
Zaposlitev pri najuglednejšem delodajalcu v Sloveniji vam prinaša 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.

Možne lokacije dela: Slovenija (Ljubljana)

Z izbranim kandidatom bomo sklenili delovno razmerje
nedoločen čas s poskusno dobo 6 mesecev
.

Prijave z življenjepisom v angleškem in slovenskem jeziku lahko oddate najkasneje do

preko spletne povezave.

Zakaj Sandoz in Lek?
Generična in podobna biološka zdravila so hrbtenica svetovne industrije zdravil. Sandoz se je kot vodilni v tem sektorju lani dotaknil življenj skoraj 500 milijonov bolnikov. Na ta dosežek smo ponosni, a si želimo še več

Z naložbami v nove razvojne zmogljivosti, najsodobnejše proizvodne lokacije, nove pridobitve in partnerstva imamo priložnost oblikovati prihodnost Sandoza in Leka ter še večjemu številu bolnikov omogočiti trajnostni dostop do cenovno ugodnih in visokokakovostnih zdravil.

Naša zagon in podjetniški duh temeljita na odprti kulturi sodelovanja, katere srce so naši talentirani in ambiciozni sodelavci in sodelavke. V okolju, kjer je raznolikost dobrodošla in kjer se spodbuja osebna rast, imajo v zameno za uporabo svojih znanj, možnost v celoti izkusiti delo v agilnem in povezovalnem okolju in z možnostjo fleksibilnega in hibridnega dela razvijati svojo kariero.

Prihodnost je v naših rokah

Predani Smo Raznolikosti In Vključenosti
Sandoz se zavzema za raznolikost, enake možnosti in vključenost. Prizadevamo si za oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo.