Operations Manager Early Translational Sciences (m/f/d) 50% temp 05/25
Job Details
Job Description
2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!
Together we will shape the future of Sandoz... are you ready to make a difference?
8 biosimilars across immunology, oncology and endocrinology are already on the market, Sandoz Biopharmaceuticals has a leading biosimilars pipeline with additional molecules in various stages of development. As Preclinical Development Manager, you contribute to the future success of our biosimilar development. You are responsible for providing nonclinical expertise to assigned global cross-functional biosimilar program teams, leading the timely planning and execution of innovative and tailored nonclinical development programs.
In Holzkirchen we are looking for an Operations Manager Early Translational Sciences in part time 50% limited until 05/2025.
Your key responsibilities:
The Manager Operations ETS is responsible for the planning and execution of innovative and tailored nonclinical studies (in vitro, in vivo) from set-up to reporting in strict adherence to any applicable guidelines, regulations and laws.
• With general direction, operationally plan, initiate and manage nonclinical studies
• Support cross-functional task forces or sub-teams
• Support nonclinical studies with respect to:
o Procurement of project proposals (RFPs) from external vendors
o Review and negotiation of vendor documents including proposals (study outline, cost proposal), service agreements, and service agreement amendments
o Contract management
o CRO qualification
• As study monitor ensure operational execution of nonclinical studies in collaboration with other line functions and external partners
• Coordinate review and approval of study plans and reports
• Coordinate study drug supply and sample, data and documentation tracking as well as nonclinical study file set-up and maintenance
• 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 GLP guidelines
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’ll bring to the role:
• Doctorate/BS/MS degree in related scientific discipline
• Excellent communication skills in English
• Excellent project management and research skills
• Excellent communication and inter-personal skills
• Experience in effectively managing costs and contracts
• Experience in negotiating study costs and contracts
• Ability to work in a multi-functional team
• Ability to handle issues with initiative and integrity
• 2+ years of industry experience in Research and Development
• Experience with GLP standards
• Attention to detail
Desirable Requirements:
• German is a plus
Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
How will we do this? 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 Sandoz!
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.
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 hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com)
2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!
Together we will shape the future of Sandoz... are you ready to make a difference?
8 biosimilars across immunology, oncology and endocrinology are already on the market, Sandoz Biopharmaceuticals has a leading biosimilars pipeline with additional molecules in various stages of development. As Preclinical Development Manager, you contribute to the future success of our biosimilar development. You are responsible for providing nonclinical expertise to assigned global cross-functional biosimilar program teams, leading the timely planning and execution of innovative and tailored nonclinical development programs.
In Holzkirchen we are looking for an Operations Manager Early Translational Sciences in part time 50% limited until 05/2025.
Your key responsibilities:
The Manager Operations ETS is responsible for the planning and execution of innovative and tailored nonclinical studies (in vitro, in vivo) from set-up to reporting in strict adherence to any applicable guidelines, regulations and laws.
• With general direction, operationally plan, initiate and manage nonclinical studies
• Support cross-functional task forces or sub-teams
• Support nonclinical studies with respect to:
o Procurement of project proposals (RFPs) from external vendors
o Review and negotiation of vendor documents including proposals (study outline, cost proposal), service agreements, and service agreement amendments
o Contract management
o CRO qualification
• As study monitor ensure operational execution of nonclinical studies in collaboration with other line functions and external partners
• Coordinate review and approval of study plans and reports
• Coordinate study drug supply and sample, data and documentation tracking as well as nonclinical study file set-up and maintenance
• 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 GLP guidelines
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’ll bring to the role:
• Doctorate/BS/MS degree in related scientific discipline
• Excellent communication skills in English
• Excellent project management and research skills
• Excellent communication and inter-personal skills
• Experience in effectively managing costs and contracts
• Experience in negotiating study costs and contracts
• Ability to work in a multi-functional team
• Ability to handle issues with initiative and integrity
• 2+ years of industry experience in Research and Development
• Experience with GLP standards
• Attention to detail
Desirable Requirements:
• German is a plus
Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
How will we do this? 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 Sandoz!
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.
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 hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com)
Company
At Novartis, we are reimagining medicine.
Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.
Novartis has one of the industry’s most competitive pipelines. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide.
We have entered an exciting era in health and biomedical innovation. Powered by our incredible colleagues, supported by our flexible-hybrid working model, new AI powered learning, personal growth and career platform and a refreshed commitment to diversity, equity & inclusion, we are well-poised to help lead this transformative moment for our industry and for ourselves. Join Us!
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