Leading Scientist (m/f/d)

DE71 (FCRS = DE071) HEXAL AG; Holzkirchen; Vor Ort; EUR 75.000 - 140.000; Vollzeit

Benefits dieser Stelle

30 vacation days

Vacation payout

Capital-forming benefits

Company pension

Hybrid working 50% in office

Learning platforms Skillsoft & LearnlI

OurShare employee equity

Zusammenfassung

Sandoz is seeking a senior Biopharma Analytical Scientist to join the Holzkirchen team. You will design and optimize analytical methods for complex biologics and lead DoE-based method development, with emphasis on quality and regulatory readiness.

Based on-site in Holzkirchen, you will collaborate with international teams, drive data interpretation, and contribute to submissions and scientific outputs while mentoring junior staff and promoting best practices.

Qualifikationen

• PhD in bioanalytical chemistry or related field with 3 years bioscience industry experience; or MSc with 6 years instrumental analytics.
• Strong knowledge of biopharmaceutical analytics and ADC characterization.
• Experience in Method Development and Method Qualification.
• Familiarity with Chromeleon chromatography software.
• Proficiency in scripting for data analysis (Python, R).
• Business fluent English.

Aufgaben

• Design and optimize analytical methods for biologics characterization.
• Coordinate method development and qualification using DoE.
• Interpret data and review raw data.
• Support regulatory submissions with analytical sections.
• Provide expert input in audits and inspections.
• Mentor scientists and contribute to publications.

Kenntnisse

Analytical chemistry

Biopharma

HPLC/UHPLC

DoE

Python/R

Chromeleon

Data analysis

English

Regulatory writing

Teamwork

Ausbildung

PhD in Bioanalytical Chemistry

PhD in Chemistry

PhD in Biotechnology

MSc in Chemistry

MSc in related field

Tools

Chromeleon

Python

Excel

Jobbeschreibung

Job Description Summary

The role is part of Biopharma Technical Development and will be based in Holzkirchen, Germany. Our Analytical Characterization Department applies a wide range of analytical methods and interesting strategic decisions in order to investigate physicochemical properties of our biosimilar products and to support biosimilar development from early stage until market entry. 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. Center of all our activities is the cooperation of all team members and the contribution of each individual Job Description Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

Your Key Responsibilities

Your responsibilities include, but not limited to:

• Independently design, develop, optimize and execute analytical methods for the characterization of biologics (e.g. monoclonal antibodies, biosimilars, ADCs and other complex molecules) using techniques such as HPLC/UHPLC techniques, capillary electrophoresis (CE-SDS, cIEF) and other physicochemical analytical methods.
• Contribute to scientific discussions, investigations and problem-solving activities within the analytical group to support project-related strategic decisions.
• Interpret analytical results, evaluate data, draw scientifically sound conclusions and review and approve raw data generated by others.
• A main focus of the role will be the coordination and supervision of method development and qualification activities according to state-of-the art method development principles including Design of Experiments (DoE) and method robustness (ICH_Q14).
• Skills in techniques as ESI-MS, ion mobility MS, HCP-MS are beneficial for the role.
• Act as a subject matter expert in global workstreams supporting strategy development, troubleshooting methods and scientific decision-making.
• Participate in global and local digitalization initiatives like LIMS Implementation and drive administration, configuration and continuous improvement of the Chromeleon Chromatography Data System (CDS) to support compliant and efficient analytical laboratory operations.
• Author development reports, study protocols, analytical procedures, method development reports, qualification/pre-validation reports and analytical method handover documents.
• Contribute to the preparation of regulatory submissions, including the drafting of analytical sections and responses to regulatory authorities, particularly for topics related to structural and physicochemical characterization.
• Act as a technical expert during audits, inspections and health authority interactions as required.
• Develop and apply scripting/programming solutions (e.g., Python, R or similar tools) to automate, improve and accelerate analytical data processing, evaluation, visualization and statistical analysis.
• Conduct literature reviews and scientific assessments, drive knowledge sharing and support the implementation of best practices.
• Train, mentor and coach scientists and laboratory personnel.
• Present scientific results internally and externally and contribute to publications, conference presentations, regulatory interactions and intellectual property activities.
• Ensure compliance with Good Documentation Practices data integrity requirements and applicable quality standards.
• Maintain accurate and complete documentation of analytical activities and ensure adherence to internal procedures and regulatory expectations.

The job will be based in Holzkirchen and requires on-site presence for most of the days.

Essential Requirements

Minimum: Degree with ideally PhD in Bioanalytical Chemistry, Chemistry, Biotechnology, Food Chemistry or other natural sciences and with 3 years of relevant experience in the biopharmaceutical industry; or Master of Science with 6 years relevant experience in the area of instrumental analytics.

• Excellent knowledge in analytical characterization of biopharmaceutical products (proteins, peptides, oligonucleotides, etc.) applying physico-chemical methods, ideally experience on characterization of ADCs.
• Excellent knowledge in Method Development and Method Qualification
• Excellent knowledge of chromatography software (i.e. Chromeleon) and computer tools.
• Excellent communication and presentation skills; willingness to work in interdisciplinary, international teams, strong record of creativity, problem solving and productivity in projects.
• Good knowledge in scripting/programming (e.g., Python, R) to drive automated data analysis and statistical evaluation is a strong advantage.
• Business fluent language skills in English

Compensation Structure & Criteria

Sandoz compensation is determined by job level, qualifications, niche skills, experience, and location within company salary ranges. Fully proficient and highly effective employees can expect a starting salary around market median, with those new to the level or with less functional depth at the lower end of the range and those with sustained superior or niche skills towards the higher end of the range. Internal equity and external market data inform our range placement. Annual salary reviews consider performance outcomes, market alignment, and business needs.

Job location: Holzkirchen, Germany Starting pay range: EUR 75,100 - 140,400 Variable compensation:5% performance-based bonus Additional benefits include: 30 vacation days per year (in full time), 1.200€ vacation payment (in full time), €40/month in capital-forming benefits (in full time), company pension, flex-hybrid working 50% per week in the office, access to our learning & development platforms Skillsoft & Learnlight, Access to our employee share program “OurShare”

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health. With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.

Our momentum 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 careers, where diversity of thought is welcomed and where personal growth is supported! Join us, help us make healthcare fairer and faster.

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.

Skills Desired

Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Project Management

Our Purpose here at Sandoz

Pioneering access for patients. As the global leader in 'off-patent' high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more! Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!