Principal Scientist – Regulatory Analytics (m/f/x)

  • Kundl
  • Vollzeit
  • Berufserfahrung
  • 13.1.2021
  • Stelleninserat
  • Arbeitgeber Einblicke
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Principal Scientist - Regulatory Analytics (m/f/x)

Verantwortungsgebiet

Principal Scientist - Regulatory Analytics (m/f/x), Sandoz Development Center, Kundl, Austria

500 million! That is how many patients we reach with our products every year, improving their lives. It is our aim to expand this to more than 1 billion - with your help and contribution as a Principal Scientist (m/f/x) in our team.

Your Responsibilities:

Your responsibilities include, but are not limited to:
• Leading and managing the entire late phase analytical development activities (specifications/justification, establishment of procedures, validations, transfers, stability studies, various documents required for file submission, lifecycle management)
• Coordination of analytical and related activities between internal and external organizations
• Subject matter expert in audits and inspections, answering deficiency letters and other authority requests, investigations
• Ensuring adherence to requirements of cGMP, pharmacopoeias, authorities and company quality system
• Working in development teams together with technical, quality and regulatory experts including close interaction with relevant functions within the Sandoz network as well as CMOs and CROs

Qualifikationen

What you'll bring to the role:
• University degree in chemistry or pharmacy or related science with focus on analytical chemistry or equivalent
• Industry experience in analytical GMP areas and a proficient university background in instrumental analytical chemistry combined with a distinct quality focus
• Proficient in English (written and spoken), German of advantage
• A deep understanding of the pharmaceutical development requirements, analytical-technological questions as well as scientific and process-oriented thinking
• Strength in organizational skills and proactive working, hands-on attitude as well as excellent communication and team orientation are essential

Desirable requirements:
• Ability to coordinate a number of tasks simultaneously, prioritize and deliver against tight timelines
• Excellent problem solving mind-set, attitude to resolve challenges, interdisciplinary thinking.
• Ability of properly balancing between efforts, risks and benefit

Contact: Jennifer Kriedemann, Talent Acquisition & Staffing Business Partner, +44 7525 702920

Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Imagine what you could do at Sandoz!

We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least EUR 51,180.50 per year on a full time basis).

Commitment to Diversity & Inclusion:
Sandoz, a Novartis company, 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 Group Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

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