The (Senior) Fellow (d/f/m) Program Mgmt. Bioanalytics Temporary, Full Time
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Job Description 20 years of experience in biosimilar development have equipped us with extensive knowledge and outstanding expertise in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide. This opportunity is waiting for you to contribute to Sandoz success story in the area of biosimilar.
The (Senior) Fellow (d/f/m) Program Management Bioanalytics (limited from 01.01.2022 till 31.12.2022) actively drives the bioanalytical and immunogenicity strategy for our biosimilar programs by representing Clinical Bioanalytics in cross-functional global teams, during health authority interactions, in audits and inspections as well as in due diligence activities.
Your responsibilities :
• Provide expert knowledge for bioanalytical methods and data evaluation (PK/PD and immunogenicity) to global program teams as bioanalytical representative and lead the bioanalytical and immunogenicity non-clinical and clinical program strategy throughout different stages in biosimilar development
• Write excellent scientific reports, briefing books for health authority interactions and registration documents (eCTD modules; Immunogenicity Risk Assessment)
• Review and interpret results, evaluate data and draw relevant conclusions; perform complex tasks without having established procedures
• Participate in audits, inspections and due diligence activities where appropriate
• Independently lead and manage projects and handle several activities at a time
• Proactively identify potential project hurdles, provide solutions and implement contingency plans
• Present scientific/strategic topics at conferences and publish internally or externally; may require up to 10% travel
Art des Stellenangebotes:
Minimum requirementsWhat you’ll bring to the role:
• Science degree with PhD and a minimum of six years relevant industrial experience, demonstrated experience in working with interdisciplinary teams as recognized expert in the international scientific community with excellent leadership skills
• Thorough understanding of development activities and strategic thinking
• Excellent theoretical and scientific knowledge in the relevant area (e.g. large molecule analytics, immunogenicity) as well as scientific project management skills
• Excellent knowledge on relevant regulatory guidelines and very good understanding of regulatory expectations paired with excellent knowledge and experience with laboratory and/or technical tools
• Good knowledge of software and computer tools
• Proficient scientific/technical writing skills
• Demonstrated successful experience with working in interdisciplinary teams, problem solving and productivity in projects
• Fluent in English (oral and written)
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!
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.
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 Novartis 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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