Planet Pharma is seeking an experienced Bioanalytical Scientist to join our client and work within the Bioanalytical and Molecular Assays team. This role will support regulated clinical studies and play a key part in bridging bioanalytical science and translational research, enabling programs to progress into the clinic and leveraging clinical findings to inform future pipeline development.
This is an 18-month fixed-term contract opportunity.
Key Responsibilities
- Lead the design and execution of phase-appropriate bioanalytical strategies, including:
- Quantification of therapeutic proteins
- Immunogenicity assessments (ADA and neutralizing antibody assays)
- PK/PD assay development, validation, and sample analysis under GCLP
- Ensure delivery of timely assay development aligned with program timelines
- Drive assay validation and qualification, ensuring methods are:
- Fit-for-purpose
- Fully compliant with regulatory requirements
- Effectively troubleshot across internal teams and external CRO partners
- Develop and optimize assays using:
- ELISA
- MSD / ECL platforms
- Multiplex ligand-binding assays (LBAs)
- Immunoblotting and other relevant technologies
- Contribute to building internal bioanalytical capabilities to support the broader pipeline
- Support:
- Equipment qualification
- SOP authoring and maintenance
- Critical reagent control and lifecycle management
- Collaborate cross-functionally with operations and sample management teams to define and streamline the sample journey
Required Qualifications & Experience
- PhD in Immunology, Immuno-oncology, Cancer Biology, or a related discipline
- (MSc candidates with extensive bioanalytical industry experience will also be considered)
- 5+ years of experience in biotech/pharma within a regulated bioanalytical environment
- Strong knowledge of GLP and GCP, with a solid understanding of regulatory expectations in bioanalysis
- Proven expertise with ligand binding assays, including:
- ECL platforms (e.g. MSD)
- Cell-based assays
- Experience with Watson LIMS
Preferred Experience
- Background working with:
- RNA therapeutics
- Biologics
- Cell & gene therapies
- Prior experience in a CRO or regulated bioanalytical lab
- Familiarity with:
- LIMS systems and electronic lab notebooks (eLNB)
Key Skills & Competencies
- Exceptional attention to detail and ability to manage multiple projects in a fast-paced environment
- Strong communication skills, with the ability to:
- Present complex scientific data clearly
- Collaborate effectively within a matrix organisation
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