Clinical Bioanalytical Expert (LC-MS & Small Molecules)
Direct message the job poster from Opterion Health AG
We are seeking an experienced Clinical Bioanalytical Expert with strong expertise in Small Molecule Characterization (LC-MS) and small molecule bioanalysis to join our Clinical Development team. The successful candidate will play a key role in the design, execution, oversight and interpretation of clinical and pre‑clinical bioanalytical activities, ensuring compliance with GxP standards and alignment with clinical program objectives. The selected expert will manage vendors and drive method development and validation.
This position requires a combination of deep scientific understanding, hands‑on laboratory experience, and strong project management and vendor oversight skills. The ideal candidate is proactive, collaborative, and capable of managing complex scientific projects while maintaining clear communication across internal and external stakeholders.
Workload: 50% (consultant or employee contract possible) for 3 months, reducing to 30% or less thereafter.
Eligibility: Applicants must hold a valid Swiss work permit or otherwise be legally authorized to work in Switzerland.
We are open to both employment and consulting arrangements for this position. To be considered, you must already hold a valid Swiss work authorization (e.g., Swiss or EU/EFTA nationality, or an existing Swiss work permit). Unfortunately, we are not able to sponsor new permits for this role.
Responsibilities
* Develop and implement bioanalytical techniques to support clinical bioanalytics.
* Oversee method development, validation, and transfer for regulated bioanalytical assays (LC-MS/MS).
* Review and interpret complex bioanalytical data to ensure data integrity, scientific accuracy, and regulatory compliance (GLP/GCLP/GCP).
* Provide expert input to clinical study designs, sample collection strategies, and bioanalytical endpoints.
* Author, review, and approve bioanalytical documentation (protocols, reports, validation summaries, regulatory submissions, lab manuals, analytical plans, supporting instructions for clinical sites).
* Train clinical staff on basics of sample handling if required.
* Lead and manage relationships with external bioanalytical laboratories (CROs) to ensure high‑quality, timely, and compliant study execution.
* Support due diligence of CROs.
* Oversee vendor qualification, contracting, and performance monitoring, ensuring adherence to quality and regulatory standards.
* Troubleshoot and resolve analytical or operational issues promptly to minimize impact on clinical timelines.
* Act as primary interface between internal teams and CROs for technical discussions, issue escalation, and delivery alignment.
* Collaborate closely with Clinical Development, Pharmacometrics, Regulatory Affairs, and Quality Assurance to ensure integrated clinical development execution.
* Communicate complex scientific findings clearly and effectively to diverse audiences, including non‑technical stakeholders.
* Represent bioanalytics in clinical project teams, audits, and regulatory inspections when required (EU and USA).
* Lead the management of bioanalytical deviations, emergencies, and data discrepancies, ensuring timely investigation and resolution.
* Drive implementation of corrective and preventive actions (CAPAs) and continuous improvement initiatives.
* Anticipate risks and establish contingency plans for critical clinical milestones.
Qualifications
* Ph.D. or M.Sc. in Chemistry, Biochemistry, Pharmacology, or a related field.
* 8+ years of relevant experience in bioanalysis with a focus on clinical‑stage studies.
* Demonstrated expertise in small molecule LC‑MS/MS bioanalysis.
* Proven experience in CRO oversight and vendor management, including method development, validation, transfer and troubleshooting.
* Strong understanding of regulatory guidelines (FDA, EMA, ICH, GCP/GLP) relevant to clinical bioanalysis.
* Experience contributing to clinical study submissions (EMA, FDA).
* Experience in PK and PD would be a plus.
* Experience with pre‑clinical studies would be appreciated.
* Experience with carbohydrate chemistry is a plus.
* Excellent communication and interpersonal skills, capable of navigating complex cross‑functional discussions.
* Strong problem‑solving and decision‑making ability, especially under time‑sensitive conditions.
* Strategic and hands‑on mindset — able to both define and operationalize bioanalytical strategies.
* Fluent in English (spoken and written); additional languages are a plus.
Why Join Us
Our Vision is: Revolutionizing dialysis care to set a new global standard in peritoneal dialysis.
Our Mission is: To relentlessly innovate for those living with chronic kidney disease, creating breakthrough therapies that put patients first. We are driven by science, guided by compassion, curiosity, and the belief that every person deserves a future free from the burdens of outdated treatments.
You Will
* Work at the interface of science and clinical development, driving impact on real‑world therapies.
* Collaborate in a cross‑functional, international environment that values scientific excellence and teamwork.
* Receive competitive compensation, professional development opportunities, and a culture focused on integrity and innovation.
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