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

Synexa Life Sciences (Pty) Ltd.; Cape Town; Presencial; ZAR 1 000 000 - 1 800 000; Tempo integral

Resumo da oferta

Synexa Life Sciences in Cape Town seeks a Principal Scientist I (Immunoassays) to provide scientific leadership across immunoassay‑based bioanalytical programmes supporting PK, ADA, and PD studies. You will mentor colleagues, support assay development, validation, troubleshooting, and client‑facing scientific activities.

The role requires PhD with ≥2 years industry or MSc with ≥7 years, deep immunology knowledge, expertise in immunoassay formats, and strong leadership and project management

Qualificações

• PhD with ≥2 years industry experience or MSc with ≥7 years hands-on experience.
• Deep immunology knowledge for effective immunoassay design.
• Experience with assay development, validation, and troubleshooting.

Responsabilidades

• Lead development, validation, and transfer of immunoassay methods.
• Mentor scientists and support audits and SOP maintenance.
• Collaborate with clients and internal teams to deliver projects.
• Support business growth through technical input for proposals.

Conhecimentos

Immunology

Molecular Biology

Biochemistry

Immunoassay development

Leadership

Project management

English communication

Data analysis software

Bioanalytical instrumentation

Formação académica

PhD in Immunology / Molecular Biology / Biochemistry (≥2 yrs industry)

MSc in relevant field (≥7 yrs hands-on)

Ferramentas

LIMS

Statistical software

Bioanalytical instrumentation

Descrição da oferta de emprego

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).

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