R&D Scientist, Test Method Development

at  Watchmaker Genomics

Position: R&D Scientist, Test Method Development
Position Type: Full-Time Employee
Department: Research and Development
Location: Cape Town, South Africa, onsite
Experience: A PhD in Biochemistry, Molecular Biology, Chemistry, or MSc with 3+ years of relevant test method development and validation experience

POSITION SUMMARY

We are seeking a talented and motivated R&D Scientist to join our Process Development team in Cape Town, South Africa. This role reports to the Process Development Team Lead and will focus on data-driven test method development, validation, and continuous improvement. The successful candidate will thrive in a dynamic, fast-paced environment and will contribute directly to our company culture and success. This position provides an opportunity to lead test method development and validation, ensuring that we continue to deliver world-class products to our customers. In this highly collaborative role, you will work closely with various departments, including R&D, Production, IT, and Quality Assurance across our global sites.

SKILLS AND REQUIREMENTS

• Proven experience in test method development and validation for biotechnology reagents.
• Expertise in statistical tools, including Design of Experiments (DOE), Statistical Process Control (SPC), Regression Analysis, Analysis of Variance (ANOVA), and Gage Repeatability & Reproducibility (Gage R&R).
• Strong understanding of data models, manipulations, and analyses, including descriptive statistics, parametric and non-parametric approaches, and data visualisation.
• Experience with ISO 13485, ISO 9001, and/or cGMP in Test Method Development, Quality Assurance, Quality Systems, Operations, or related fields.
• Broad technical knowledge of life science reagents, genomics, next-generation sequencing (NGS), PCR, and/or recombinant protein production is highly desirable.
• Demonstrated scientific excellence in technical work, written communication, and presenting technical information to diverse audiences.
• Ability to multitask, perform under pressure, and work independently.
• Strong interpersonal skills with a proven ability to drive results in cross-functional teams.
• Exceptional organisational skills and attention to detail.
• Strong written and verbal communication skills.

EDUCATION AND EXPERIENCE

• PhD in Biochemistry, Molecular Biology, Chemistry, or Statistics OR MSc with 3+ years of relevant experience in test method development and validation.

APPLICATION REQUIREMENTS

To apply for the position, please submit the following in a PDF format on watchmakergenomics.com:

• Letter of motivation (upload where it says cover letter)
• Resume or Curriculum vitae, highlighting relevant qualifications and experience

Applications without a Letter of Motivation will not be considered. Local candidates preferred.
If selected to participate in the interview process, the names and contact information of three professional references who are able to assess your suitability for the position in terms of the specified requirements will be requested.
To ensure your application is considered, please submit it by Monday, 14 October 2024. Please note that this position may close earlier if we receive a high volume of applications. We encourage you to apply as soon as possible.

• Lead test method activities throughout the Product Life Cycle, from development to continuous improvement.
• Collaborate with key stakeholders to define and implement test method development and validation strategies.
• Work with R&D and Production teams to develop and transfer test methods, including defining critical parameters and mitigating risks.
• Manage and execute projects focused on test method development and validation, ensuring that robust methods are transferred to Production.
• Design statistically powered test method validation studies.
• Analyse data using advanced statistical methods.
• Communicate results and provide guidance on product specifications.
• Train Quality Control analysts on test methods, laboratory procedures, and quality systems, including good documentation practices and data review.
• Contribute to validation activities, including process validation, computer systems validation, and equipment qualification.
• Identify and implement test method requirements, such as materials, equipment, software, and facilities design.
• Conduct experiments with scientific rigour and accurately record, communicate, and present findings.
• Support laboratory maintenance, including ordering materials, maintaining equipment, and ensuring a clean and organised lab.
• Operate under Watchmaker’s Quality System, contributing to the implementation and adherence to ISO13485 standards, including leading non-conformance and corrective action investigations.