Leading Scientist (m/f/d)

Sandoz; Holzkirchen; Vor Ort; EUR 75.000 - 140.000; Vollzeit

Benefits dieser Stelle

30 vacation days per year

1,200€ vacation payment

Capital-forming benefits €40/month

Company pension

Flex-hybrid working 50% in office

Learning platforms Skillsoft & Learnl

Employee share program OurShare

Zusammenfassung

Sandoz, based in Holzkirchen, Germany, seeks a biopharmaceutical analytical scientist to design and execute advanced methods for biosimilar characterization. You will lead DoE-driven method development, coordinate qualification, and contribute to regulatory documentation.

Applicants should have a PhD or MSc with substantial instrumental analytics experience, with strong HPLC/CE-based methods and scripting skills in Python or R. On-site role with international collaboration is expected.

Qualifikationen

• Minimum: PhD in Bioanalytical Chemistry or related field with 3 years in biopharma; or MSc with 6 years in instrumental analytics.
• Excellent knowledge in analytical characterization of biopharmaceutical products using physico-chemical methods, incl. ADCs.
• Strong Method Development & Qualification knowledge

Aufgaben

• Design, develop, optimize and execute analytical methods for biologics characterization (e.g., mAbs, biosimilars).
• Coordinate method development and qualification according to DoE and ICH Q14.
• Support regulatory submissions with analytical sections and responses.
• Automate data processing and statistical evaluation using Python or R.
• Mentor and coach scientists; present results internally and externally.

Kenntnisse

Analytical characterization

Method development

DoE (Design of Experiments)

Programming (Python/R)

HPLC/UHPLC

Chromeleon CDS

Team collaboration

English proficiency

Ausbildung

PhD in Bioanalytical Chemistry or related

MS with 6+ years instrumental analytics experience

Tools

Chromeleon

ESI-MS

Ion Mobility MS

HCP-MS

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.

What you’ll bring to the role:

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

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”
• Pay frequency: Monthly
• Expected weekly working hours: 40 hours
• Contract type: full time

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!

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.

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.

#Sandoz

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