Bioassay Scientist I Endpoint Manager

3 weeks ago

Cape Town, South Africa Hutchinson Center Research Institute of South Africa Full time

**Responsibilities**:
**Management and Training of the Endpoints Lab Team (30%)**
- Supervise a team of laboratory technologists performing assays for clinical trials and research purposes, including assays such as multiparameter flow cytometry, multiplex protein detection and molecular assays.
- Develop and maintain a relevant and dynamic training program, monitoring retraining as needed.
- Perform and oversee hands-on lab training and conduct frequent lab observations to ensure high quality lab technique and strict adherence to SOPs
- Facilitate and guide capacity development within the team.

**Conduct of Laboratory Studies (30%)**
- Plan and execute studies to answer immunological questions related to vaccination by performing and overseeing laboratory assays, troubleshooting experiments as required
- Communicate findings in presentations, reports or other written formats
- Follow, update, modify and write lab protocols, Standard Operating Procedures (SOPs), Study
- Specific Procedures (SSP), Final Study Reports (FSRs) and other study-related documents/reports.
- Ensure all necessary reagents and equipment are available, directing others as necessary.
- Work closely with other laboratory teams to ensure seamless and accurate execution of sample analysis.
- Work closely with lab operations team to ensure lab maintenance is up to date by scheduling weekly/monthly related activities
- Manage projects, interfacing with laboratory leadership, lab personnel, statistical and clinic staff as required to ensure the success of the overall study goals
- Work closely with data management (SCHARP) on data transfer plan, subsequent data uploads and reviewing of QC reports.
- Attend, lead and participate in appropriate laboratory meetings.
- Work with team on continuous process improvements related to the running of the studies to ensure efficiency and improved working environment.

**Laboratory Documentation (20%)**
- Ensure the Endpoints team conducts all work according to Good Clinical Laboratory Practice (GCLP) guidelines and auditable-standards, ensuring accurate and timely reporting and record keeping.
- Review laboratory documentation to ensure accuracy, completeness and compliance with appropriate GCLP regulations and requirements

**Quality Assurance (20%)**
- Act as Study Director for clinical studies performed according to Division of AIDS GCLP guidelines. This includes the writing of study related documentation and study related training of staff, ensures the integrity of data collected, clearly document and follow-up on deviations and archiving of all related study documents.
- Monitor assay quality in conjunction with the Biomarker team throughout clinical sample analysis
- Develop and manage relevant components of quality systems (documentation, training, deviation reporting etc.)
- Lead assay-related parts of external and internal audits with QA unit.
- Work closely with the QA Associate to create and maintain an environment of continual quality improvement, including monitoring of key measures of quality and incident management

Other duties as required

**Qualifications**:
**MINIMUM QUALIFICATIONS**:

- PhD in immunology or related field with at least 3 years of management experience or Masters degree in immunology or related field with 10 years of experience in clinical bioassays, including at least 5 years of management experience.
- Experience in multi-parameter flow cytometry, especially intracellular cytokine staining assays preferred.
- Experience working in a GCLP laboratory in a clinical trial setting preferred.
- Experience supervising others in a fast-paced, deadline-driven team environment.
- Experience in leading, managing and developing people, including an ability to motivate others to create and a culture that is supportive and proactive.
- Data analysis skills using FlowJo and other computer programs (e.g., GraphPad Prism, JMP), basic statistics, data interpretation
- Strong scientific writing skills

**PREFERRED QUALIFICATIONS**:

- Strong leadership and management abilities to effectively manage a team.
- Excellent attention to detail.
- Advanced project management skills, excellent time management skills and ability to work within set deadlines.
- Understanding of importance, implementation and maintenance of GCLP principles.
- Highly flexible and adaptable to the changing needs of a fast-paced and dynamic environment with a desire to learn.
- Flexibility around working hours to accommodate operational and study needs
- Effective communication (oral, written and presenting) and interpersonal skills.
- Ability to take initiative and work independently, multitasking as required
- Advanced problem-solving skills.

Pay: From R50 000,00 per month

Application Deadline: 2024/06/30

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