338097BR
Feb 08, 2022
Austria

Job Description

Drug Product Project Lead (m/f/d) (Senior Expert Science & Technology), Global Drug Development, Schaftenau, Austria

45+ curious and engaged scientists are developing together 15+ New Biological Entity and Biosimilar projects in the Drug Product Development team in Schaftenau! We are seeking you to join the team as an experienced scientist with project management skills to drive a wide range of activities ranging from formulation development and process development to process characterization and validation studies. Enjoy an inspired environment with a clear purpose – bringing medicines to patients! with your help and contribution as a Drug Product Project Lead (m/f/d) (Senior Expert Science & Technology.

Your responsibilities include, but are not limited to:
• Drug Product Project Leader (DPPL) is the strategic lead of overall DP technical development (DPD) and is accountable for agreed-upon deliverables to the CMC team, the scientific content of the development program.
• Represents DPD on the CMC core team & leads the global drug product sub-team with the cross-functional member.
• Leads and coordinates timely delivery of high-quality source documents for submission, review of regulatory documents (e.g. CMC modules, briefing books).
• May design, plan, perform, interpret, and document scientific experiments for the pharmaceutical development, characterization of formulation, and process; upscale and transfer of processes and supports process validation and registration of the product.
• Proactively communicates overall project strategy, assesses and consolidates resources needs (internal and external costs) and eventually applies general make-versus-buy strategy.
• Sets priorities for the DP team; supports the growth of DP team members and motivates them as appropriate by encouraging and servant leadership.
• Leads and manages the technology transfers of drug product manufacturing processes from development sites and partners to internal/external manufacturing sites.
• Develops, mentors and coaches fellows and other scientific associates helping them grow their potential; present scientific/technical results internally and contribute to publications, presentations, and patents.

Diversity & Inclusion / EEO

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

Minimum Requirements

What you’ll bring to the role:
• Ideally Ph.D. in pharmaceutical technology, biotechnology, chemical engineering or another relevant discipline.
• Experience (minimum 3 years) of work related to the pharmaceutical industry in relevant roles e.g. project leader, formulation or manufacturing processes development, technical transfer, validation and submission, desirable knowledge in sterile DP manufacturing.
• Proficient in quality principles, QbD, GMP, regulatory aspects of the pharmaceutical industry
• Experience with leading 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 proficient project management and organizational skills, communication skills, team spirit, who are results-driven and open to new challenges in a global, cross-functional environment.

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 invited to submit your application, including CV.

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position, the minimum salary is € 52.204,04/year (on a full-time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications, and individual competencies.

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.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.

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
Global Drug Development
TECHNICAL R & D GDD
Austria
Schaftenau
Research & Development
Full Time
Regular
No
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338097BR

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

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