Operations Manager Early Translational Sciences (ETS) (d/f/m)

Posted 2 Days Ago
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Holzkirchen, Bayern
Junior
Biotech • Pharmaceutical
The Role
The Operations Manager will oversee bioassay operations and nonclinical studies, manage vendor contracts, and support quality management systems, ensuring compliance with guidelines.
Summary Generated by Built In

Job Description Summary

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our ‘new’ Sandoz!


 

Job Description

Your Key Responsibilities:

Your responsibilities include, but not limited to:

  • All operational activities regarding planning, initiating and managing of state-of-the-art bioassays for functional characterization of biosimilars (including method development) as well as innovative and tailored nonclinical studies (in vitro, in vivo) at external vendors from set-up to reporting in strict adherence to any applicable guidelines, regulations and laws
  • Operational activities for bioassays and nonclinical studies include support with respect to:
    • Request for project/cost proposals (RFPs) from external vendors
    • Review and negotiation of vendor documents including proposals (study outline, cost proposal), service agreements, and quality agreements
    • Contract management
    • Vendor qualification
  • Sponsor oversight to ensure operational execution of bioassays and nonclinical studies in collaboration with other line functions
  • Support cross-functional task forces or sub-teams
  • Coordinate review and approval of documents (e.g. qualification/study plans and reports)
  • Coordinate drug supply and tracking of samples, data and documentation as well as other Sponsor documentation
  • Plan and monitor ETS project budgets
  • Support set-up and improvement of quality management system (including SOP generation) for ETS team and ensure a high-level quality standard in ETS processes, including conformity to applicable guidelines (bioassays, GLP)

What you’ll bring to the role:

Essential Requirements:

  • Doctorate/BS/MS degree in related scientific discipline
  • 2+ years of industry experience in Research and Development
  • Excellent project management and research skills
  • Excellent communication and inter-personal skills
  • Experience in effectively negotiating and managing study costs and contracts
  • Ability to work in a multi-functional team
  • Ability to handle issues with initiative and integrity
  • Attention to detail
  • Excellent communication skills in English

Desirable Requirements:

  • Experience with GLP standards
  • Experience with different IT tools (e.g. SAP)
  • German is a plus

You’ll receive:

Sandoz has an employee-first approach and that’s why your personal growth is so important to us. You will have access to Coursera and other learning platforms with more than 200,000 learning videos and 5000+ courses.

In addition to the various learning opportunities, we offer company benefits, such as:

  • 30 days of annual leave
  • Holiday allowance
  • Additional rewards for special occasions (e.g. service length awards, marriage celebration, etc.)
  • Company pension schemes and capital formation benefits
  • Parental leave
  • Other offerings, such as bike leasing

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:

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

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Join our Sandoz Network:

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

#Sandoz


 

Skills Desired

Clinical Trial Protocol

Top Skills

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The Company
HQ: Basel
110,000 Employees
Hybrid Workplace
Year Founded: 1996

What We Do

Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.

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