337751BR
Apr 13, 2022
Germany

Job Description

1996! In this year Sandoz initiated the world’s first biosimilar development program. The exciting field of analytical characterization deals with the analysis of the physicochemical properties of our therapeutic proteins and is part of the global Novartis Technical Research and Development (TRD) department.
We focus on the analysis of our biosimilar products and exciting new biological entities, which we support from early development until market entry.

If you have a minimum of 6 years of relevant experience in the biopharmaceutical industry and Ph.D. degree in biotechnology, chemistry or other natural sciences, this might be a great opportunity for you to join Sandoz.

As Sandoz Characterization Analytical Expert you will be supporting the characterization of DS / DP through various project phases from clone selection to process characterization, method transfers, comparability studies, similarity and submission. A wide range of analytical methods and interesting strategic decisions shape your mission. Center of all our activities is the cooperation of all team members and the contribution of each individual.


Your responsibilities:

• Independently manage project activities in the area of analytical characterization (e.g. method-development for characterization of the API, as well as their optimization, validation, -transfer including the know-how and troubleshooting, and ensure their implementations etc.) and contribute to project-specific strategy decisions.
• Represent own function in technical teams (e.g. global CMC team); perform all project tasks (e.g. design, plan, and support conducting scientific experiments; actively contribute to budget and resource forecast etc.) and responsibilities related to own scope of work, as well as assist leadership team in setting goals, performance evaluations, and development planning discussions with team members.
• Review and approve analytical results. Ensure integrity of data. Interpret results within relevant context, draw the right conclusions and share with the analytical sub-team.
• Prepare protocols, scientific reports, laboratory procedures, or project-related SOPs; write scientific documents for external partners (e.g., other line units, health authorities). In particular: coordinate and compile high quality analytical registration documents for HA submissions and write publications, patents; interact with Health Authorities where appropriate; act as technical expert in audits, inspections, and etc.

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

.Minimum Requirements:

• Ph.D. degree in biotechnology, chemistry or other natural sciences + a minimum of 6 years relevant experience in the biopharmaceutical industry.
• Expert knowledge in the area of analytical characterization of biopharmaceutical products, excellent laboratory and technical expertise (analysis of proteins, antibodies, data evaluation). Experience for Analytical Project Management is a plus
• Thorough understanding of development activities and –processes in biopharmaceutical industry; excellent knowledge on relevant regulatory guidelines and very good understanding of regulatory expectations
• Proficient scientific/technical writing skills (to compile analytical reports and submission documents in English), and excellent presentation and communication skills
• Expertise in Mass spectrometry, monoclonal antibodies, biopharmaceuticals physicochemical characterization, Surface plasma resonance and Project management


Desirable Requirements:

• Proficiency level of English (verbal 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.

Join us, and help reimagine access to medicine.

Sandoz stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
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Global Drug Development
TECHNICAL R & D GDD
Germany
Oberhaching (near Munich)
Research & Development
Full Time
Regular
No
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337751BR

Characterization Analytical Expert - Fellow (m/f/d)

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