Principal Scientist I – Immunoassay Bioanalysis (PK/ADA/PD)

Synexa Life SciencesCape Town, Western CapeOn-siteFull-timeNew grad, 0–1 yearsListed 1 hour ago

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About this role

Job Purpose

The Principal Scientist I (Immunoassays) provides scientific leadership across immunoassay-based bioanalytical programmes supporting pharmacokinetic (PK), anti-drug antibody (ADA), and pharmacodynamic (PD) studies. This role serves as a senior scientific resource within the immunoassay group, supporting assay development/optimisation, validation, troubleshooting, and client-facing scientific activities.

The successful candidate will contribute to scientific excellence, mentor colleagues, support business growth initiatives, and help ensure the long-term success and robustness of immunoassay platforms and methodologies.

Main Areas of Responsibility

Scientific Leadership & Technical

- Serve as SME in the development, validation, and/or transfer of ligand-binding and cell-based assays across a variety of platforms (ELISA, MSD ECL, FL, LUM), ensuring methods are scientifically appropriate and fit-for-purpose according to regulatory guidelines.

- Lead investigations of assay challenges, including matrix effects, assay variability, sensitivity limitations, and non-specific binding.

- Mentor and train junior and mid-level scientists on assay design, troubleshooting and best practices.

- Drive operational and scientific improvement through support of internal audits, protocol enhancements, and corrective-preventive action initiatives.

- Author/review/maintain SOPs, guidance documents, and policies where applicable.

- Represent the group in scientific forums, workshops, webinars or publications where appropriate.

Business Development & Client Engagement

- Participate in scientific discussions with clients regarding assay progress and data interpretation.

- Build effective working relationships with clients and internal stakeholders to support successful project delivery and cultivate long-term relationships.

- Support proposal preparation, bid-defence activities, and technical input for new business opportunities.

Qualifications & Experience

Required:

- PhD in Immunology, Molecular Biology, Biochemistry, or related discipline with ≥2 years’ industry experience OR MSc in a relevant field with ≥7 years’ hands-on experience.

- Deep understanding of immunology, and how to leverage principles for effective immunoassay design.

- Expertise in immunoassay formats and methodology, as well as development and/or troubleshooting. Experience in any degree of assay validation/transfer or fit-for-purpose testing will be advantageous.

- Understanding of key bioanalytical principles including sensitivity, selectivity, precision, robustness, and assay performance monitoring will be advantageous.

- Excellent leadership and cross-functional collaboration skills.

- Strong communication (in English) and project management skills.

- Proficiency with data analysis software and common bioanalytical laboratory instrumentation.

Preferred:

- Experience in one or more of the following areas would be advantageous:

Therapeutic proteins and monoclonal antibodies.

- Cell-based functional assays.

- Multiplex or emerging immunoassay platforms.

- Experience in SOP and report writing.

- Prior involvement in client-facing activities, proposal/grant writing, scientific presentations and publications.

- Exposure to GxP environments and associated quality management systems advantageous.

- Experience with laboratory informatics systems (LIMS or similar).

PLEASE ENSURE THAT YOUR CV/RESUME IS SUBMITTED IN ENGLISH.

Synexa Life Sciences is committed to achieving transformation and will take it’s EE plan and targets into consideration during the selection process.