(Senior) Bioanalytical Principal Investigator LBS / GLP Study Director (100%)

Multiscreensite

Zürich

Ibrido

CHF 110.000 - 170.000

Tempo pieno

13 ore fa
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Vantaggi offerti da questo lavoro

Extra holidays
Company-paid sickness and accident 보험
Commuting allowance
Reka-Checks
Flexible working hours
Flat organizational structure

Descrizione del lavoro

Celerion in Fehraltorf/Zurich is seeking a (Senior) Bioanalytical Principal Investigator to lead GLP/GxP bioanalytical studies and method validations. You will act as Study Director/PI with full responsibility for studies and serve as the primary client contact, delivering high-quality data to support drug development globally.

This role requires strong scientific leadership, expertise in LBA and cell-based assays, and experience in regulated environments.

Competenze

  • BSc or MSc in Life Sciences or related field is required.
  • 2+ years of professional bioanalytical experience; 6+ years for senior level.
  • Experience in regulated GLP/GxP environments (GLP, GCP, GMP, ISO).
  • Strong analytical and problem-solving skills with high attention to detail.
  • Excellent English; German skills are advantageous.
  • Experience as Study Director or PI in leadership role is required for senior level.

Mansioni

  • Lead GLP/GxP bioanalytical studies and method validations.
  • Serve as Study Director/PI with responsibility for studies.
  • Develop and approve study plans, protocols, reports, and documentation.
  • Review data for scientific integrity and regulatory compliance.
  • Coordinate client communications and lead study discussions and audits.
  • Train and mentor laboratory staff; drive process improvements.
  • Lead complex client programs and contribute to business initiatives.

Conoscenze

GLP/GxP compliance
Study leadership
Bioanalytical techniques
Client management
Regulatory knowledge
English communication

Formazione

BSc/MSc in Life Sciences or related

Strumenti

LBA
Cell-based assays

Descrizione del lavoro

(Senior) Bioanalytical Principal Investigator LBS / GLP Study Director (100%)

Shape the future of bioanalysis for innovative medicines

Celerion is one of the world's leading bioanalytical contract research organizations and has been supporting pharmaceutical and biotech drug development programs around the world for more than 40 years.

To strengthen our bioanalytical laboratory in the Ligand Binding Service Team in Fehraltorf / Zurich, we are looking for a

(Senior) Bioanalytical Principal Investigator (100%)*

In this role, you will take scientific and operational ownership of regulated bioanalytical studies and method validations. You will serve as the primary client contact, lead study execution from planning through reporting, and play a key role in delivering high-quality data to support drug development programs worldwide.

* This is a dual-level posting. The hiring team will determine the final level and title of the role based on the skills, experience, and capabilities required for the level offered.

Main responsibilities

Study Leadership & Scientific Oversight

  • Lead and oversee GLP/GxP-compliant bioanalytical studies and method validations within the Ligand Binding Services (LBS) department.
  • Act as Study Director and/or Principal Investigator with full responsibility for assigned studies or study phases.
  • Develop and approve study plans, validation protocols, analytical reports and associated study documentation.
  • Review, evaluate and approve analytical data to ensure scientific integrity and regulatory compliance.
  • Ensure all study activities are conducted in accordance with applicable SOPs, regulatory requirements and client expectations.

Client Management

  • Serve as the primary scientific and operational contact for assigned clients.
  • Provide regular project updates and maintain strong communication throughout the study lifecycle.
  • Support client meetings, scientific discussions and audits as required.

Operational Excellence

  • Coordinate laboratory activities and ensure efficient study execution.
  • Train, mentor and support assigned laboratory personnel.
  • Contribute to process improvements and continuous enhancement of laboratory operations and quality standards.
  • Support bioanalytical data management activities and documentation review processes.

Additional Responsibilities for Senior-Level Candidates

  • Lead complex or strategic client programs.
  • Provide scientific mentoring and guidance to junior Principal Investigators and laboratory staff.
  • Act as a subject matter expert for ligand-binding and cell-based assay technologies.
  • Contribute to business development activities, client presentations and scientific initiatives.
Our requirements
  • BSc / MSc in Life Sciences, Biochemistry, Biotechnology, Immunology or related field
  • At least 2 years professional experience, at least 6 years for senior position
  • Practical experience in relevant bioanalytical techniques (e.g. LBA, cell-based), preferably in an industry setting
  • Experience working in a regulated environment (GLP, GCP, GMP and/or ISO standards)
  • Strong analytical and problem-solving skills
  • Detail-oriented and highly organized, with the ability to manage multiple projects while maintaining a high level of quality and attention to detail
  • Excellent computer and time management skills
  • Highly self-motivated, reliable, and flexible, with a commitment to providing excellent service to clients.
  • Strong team player with the ability to collaborate effectively across functions
  • Excellent English (written and spoken), good German skills are advantageous
  • Previous experience as a Study Director, Principal Investigator or equivalent scientific leadership role is required for the senior position
  • Knowledge of biomarker, pharmacokinetic (PK), immunogenicity (ADA) or biologics bioanalysis
  • Experience working directly with pharmaceutical or biotechnology clients is advantageous
We provide an opportunity to assume work independently, secure long-term employment, and enjoy a competitive salary.
Your workplace will be located within our state-of-the-art equipped automated facilities in cantone Zurich as part of an international organization.
Additionally, you will experience the advantages of flexible working hours and experience the benefits of a medium-sized company with flat organizational structure within a dynamic and international team.
Our benefits: extra holidays, company-paid sickness and accident insurance, commuting allowance and access to Reka-Checks.
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