337980BR
Apr 26, 2022
Slovenia

Job Description

+ 1300! In TRD Biologics & CGT, more than 1,300 associates spread across 5 geographies are fully committed to deliver on our evolving pipeline of transformative treatments. We develop Biologics and Cell & Gene Therapies drug substance and drug products from candidate selection up to launch and drive competitive advantage thru agility, innovation, and scale to best serve our portfolio, partners and patients.

The position focuses on leading development activities for sterile biologics drug product covering different phases of the development - formulation development, support to toxicological studies and PhI/II/III clinical studies, development and characterization of sterile DP manufacturing processes (PhI/II/III, commercial), transfer of manufacturing processes from laboratory to production scale, support of validation and registration activities.

Your key responsibilities
• Leads the drug product sub-team and is accountable for the drug product project activities, owns the drug product project strategy in alignment with the technical development plan (TDP) and represents the project drug product sub-team in the CMC project team.
• Sets priorities and objectives within the drug product sub-team.
• Is responsible for and track project progress according to defined timelines, define the critical path within the sub-team project plan, identify together with the sub-team roadblocks/risks and issues, develop solutions and mitigation plans/scenarios.
• Assesses and consolidates resources needs (internal and external costs).
• Coordinates and timely delivery of high quality source documents for submission, review of regulatory documents (e.g. CMC modules, briefing books); provides content to HA questions or Investigator Brochure.
• Actively participates in knowledge exchange.
• Trains and coaches associates and peers with regard to special responsibility.
• Leads and manages the technology transfers of drug product manufacturing processes from development sites and partners to clinical and commercial internal/external manufacturing sites until technical transfer closure.


Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

What you will bring to the role
• Advanced degree (desirable PhD) in pharmaceutical technology, biotechnology, chemical engineering or other relevant discipline.
• Experience (minimum 3 years) of work related to pharmaceutical industry experience in relevant roles e.g. project leader, formulation or manufacturing processes development, desirable knowledge in sterile DP manufacturing.
• Solid understanding about quality principles, QbD, GMP, regulatory aspects of pharmaceutical industry.
• Experience with working in interdisciplinary and cross-cultural teams.
• Excellent communication/presentation skills and scientific/technical writing skills.
• Active knowledge of English language required (oral & written).


We are looking for candidates with good project management and organization skills, communication skills, team spirit, who are result driven and open for new challenges in a global, cross-functional environment..

You’ll receive:
Flexible working schedule, competitive compensation package, annual bonus, possibility to work from home, pension scheme, employee recognition scheme, sports club membership, employment at Top SI employer, learning and development opportunities and much more.

We offer permanent contract, work in a dynamic environment, collaboration with different teams, knowledge and experience sharing within the global Novartis system. You are kindly encouraged to submit your application, including CV, by 10th of May, 2022.


Why consider Novartis?
769 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network. If this role is not suitable to your experience but you wish to stay connected to Novartis and our career opportunities in the same field, we encourage you to join the Novartis Talent Pool on link below.

https://talentnetwork.novartis.com/network
Global Drug Development
TECHNICAL R & D GDD
Slovenia
Menges
Research & Development
Full Time
Regular
No
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337980BR

Drug Product Project Lead (m/f/d) (Senior Expert Science & Technology)

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