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Lek, a Sandoz company

Director Technical Portfolio and Project Management Biosimilars - Technical Project Leader Biosimilars (d/f/m)

Lek, a Sandoz company
Slovenia · Full-time · Director

Job Description

1996! In this year Sandoz initiated the world’s first biosimilar development program. Almost 30 years of experience in biosimilar development have equipped us with extensive knowledge and outstanding expertise in the development, manufacturing and commercialization of biosimilar medicines.

This opportunity is waiting for you! Join us as a Technical Project Lead and become a key contributor to our Sandoz mission of »making access happen« for all patients.

For the technical development of our biosimilar pipeline, we are looking for a Director Technical Portfolio and Project Management Biosimilars (Technical Project Lead) (d/f/m) who will represent technical development in global program and project teams and define the global CMC strategy for the development, submission, approval and life cycle management of the assigned product(s). You will lead the CMC team comprising subject matter experts with strong strategic focus, quality awareness as well as scientific and technical expertise in biologics/biosimilar development and manufacturing. With your strong and agile leadership skills, you will act as the advocate for your projects(s) and communicate with global projects teams, CMC line functions and your team.

Your Key Responsibilities

  • Lead the establishment and execution of a scientifically sound and business driven CMC strategy for biosimilar projects including technical risk assessments and contingency planning, together with assigned CMC team and in line with the overall program and project global strategies.
  • Seek alignment with departments and functions in- and outside of Sandoz Biologics Technical Development (e.g. Regulatory, Technical Operations, Quality, Clinical, Marketing, Safety) and proactively communicate the overall CMC project strategy, progress and key risks as well as any other critical topics timely to the defined management levels, customers and stakeholders.
  • Drive the resolution of technical challenges in a timely manner.
  • Lead the CMC team(s) in a complex international matrix organization and in line with the culture, values and behaviors of Sandoz.
  • If required, support in- and out-licensing of biosimilar project activities.

What You Will Bring To The Role

  • Minimum: Advanced degree in life sciences or relevant technical discipline.
  • Fluent knowledge of business English.
  • 5+ years project management experience in a matrix organization or cross-functional team organization or 5+ years multi- / cross-functional leadership experience with biosimilars/biologics technical development, manufacturing and registration.
  • Strog knowledge of technical development and manufacturing technologies (Drug Substance, Drug Product devices), Good Manufacturing Practice and quality systems, and regulatory processes; fundamental cross-functional knowledge (clinical, commercial) regarding drug development.
  • Strong people skills: Ability to facilitate communication between technical, clinical and commercial participants / different functions for effective global team collaboration.
  • Strong leadership skills: Experience with development, coaching and mentoring of team members; excellent influencing, communication and presentation skills (oral and written).

You’ll Receive

Employment at a most reputable employer in Slovenia/Austria/Germany 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 / Germany / Austria.

We offer permanent contract with 6-month of probation period. You are kindly invited to submit your application in English language, including CV, by May 4th, 2025.

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.

Join Our Sandoz Network

If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool

#Sandoz #BioRampUp

Key Skills

Ranked by relevance

technical expertise
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Posted
Apr 11, 2025
Type
Full-time
Level
Director
Location
Ig

Industries

Pharmaceutical Manufacturing

Categories

Finance Sales

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