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Associate Director, Analytical Strategy (m/w/x)

CSL Behring -
Bern, BE

Jetzt bewerben

Details zur Stelle

100% | Pensum: 90-100%

Leistungen

Unterkunft

Qualifikationen

Doktorat
R
Master
Führungserfahrung

Vollständige Stellenbeschreibung

Entity: CSL Behring

Job Category: Research Development & Sciences

Job Family: Discovery & Product Development

Job Type: Full Time

Location: Bern, Berne, Switzerland

Employer Reference: R-287031

Job Description

Associate Director, Analytical Strategy (m/f/x)

The Associate Director, Analytical Strategy will lead the development and execution of analytical strategies to support biopharmaceutical development programs. This role
requires deep molecular knowledge, expertise in analytical testing and molecule characterization, and a strong understanding of Quality by Design (QbD) principles and
regulatory requirements. The successful candidate will drive analytical decision-making, ensure robust characterization of molecules, and support regulatory submissions
with scientific rigor.

Main Responsibilities & Accountabilities

Strategic Leadership

Develop and lead the global analytical strategy aligned with program and corporate goals
post-marketing)
Drive innovation in analytical technologies, platforms, and workflows

Scientific Oversight

Oversee development, validation, and implementation of analytical methods (e.g., LC-MS/MS, ligand binding assays, biomarkers, immunogenicity)
Ensure high-quality data generation for PK, PD, biomarker, and immunogenicity studies
Review and approve analytical study designs, reports, and regulatory documentation

Regulatory & Compliance

Ensure compliance with global regulatory guidelines (FDA, EMA, ICH, GLP, GCP)
Lead analytical sections of regulatory submissions (IND, CTA, NDA, BLA, MAA)
Interface with regulatory agencies and respond to health authority queries

Cross-Functional Collaboration

Partner with Clinical Pharmacology, DMPK, Toxicology, Biomarkers, and Clinical Operations
Support translational strategy and dose selection decisions

Leadership & Management

Lead and mentor analytical scientists and project leaders
Manage budgets, timelines, and resource allocation

Qualifications & Experience Requirements

PhD in analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field (or MSc with extensive experience)
Typically 8+ years in bioanalysis within biotech, pharma, or CRO environments
Deep expertise in LC-MS/MS, ligand binding assays, biomarkers, and immunogenicity testing
Strong knowledge of regulatory requirements and analytical validation standards
Proven leadership and strategic program experience
Experience supporting regulatory submissions and health authority interactions

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

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research associate Jobs in bern, be

Associate Director, Analytical Strategy (m/w/x)

Assistant Professor with Tenure Track (open rank) or Associate Professor of Palliative Medicine combined with the role of Head Physician of the UZP

Discover related jobs

Ich möchte aktuelle Job-E-Mails für Stellen als research associate in bern, be erhalten

Weitere Job-Standorte erkunden

Job Description

Associate Director, Analytical Strategy (m/f/x)

About CSL Behring

Our Benefits

You Belong at CSL

Equal Opportunity Employer

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