Process Development Scientist

Position: Process Development Scientist, Test Method Development

Focus Area: Test Methods

Position Type: Full-Time Employee

Location: Cape Town, South Africa, onsite

Experience: PhD with 0 - 5+ years of relevant test method development and validation experience

Company Summary

Watchmaker Genomics is a global life sciences company with R&D and production facilities in Cape Town, South Africa, and headquarters in Boulder, Colorado. Our team is driven by a passion for innovation and a commitment to collaboration, creativity, and scientific rigor. We believe that the intersection of biology, engineering, and computer science offers exciting opportunities to develop novel technologies that advance research and enhance human health. We leverage our enzyme engineering and computational biology capabilities to develop products that support high-growth applications in genomics, molecular diagnostics, and personalized medicine.

Position Summary

We are seeking an R&D Scientist to join our Process Development team in Cape Town, South Africa.

As part of the Process Development team you will apply your expertise to data-driven test method development, validation, and continuous improvement. You will contribute directly in delivering 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.

Key Responsibilities

• The Process Development team supports the transfer of new products from R&D to Production. This includes the risk-based identification and development of robust and precise quality control tests. After product launch, the team provides ongoing support for process updates to maintain product quality.

Specific responsibilities include:

• Support test method development activities throughout the Product Life Cycle, from development to continuous improvement.

• Work with R&D and Production teams to develop and transfer test methods, including defining critical parameters and mitigating risks.

• Plan 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.

• Additional responsibilities as assigned.

• Skills and Requirements

Required skills are:

• Demonstrated technical knowledge of and practical expertise in enzyme kinetics, PCR & qPCR and/or NGS
• Strong understanding of data models, manipulations, and analyses, including descriptive statistics, parametric and non-parametric approaches, and data visualisation
• Demonstrated scientific excellence in technical work, written communication, and presenting technical information to diverse audiences
• Critical thinking and problem-solving skills.
• Commitment to a culture of excellence and advocacy for continuous improvement.
• Strong interpersonal skills and an excellent ability to drive results in multi-level, cross-functional teams.
• Excellent organizational skills and outstanding attention to detail.
• Strong personal task management skills and a high level of self-motivation.
• Excellent written and verbal communication skills.

Advantageous skills are:

• Proven experience in test method development and validation for biotechnology reagents under ISO 13485.

• Expertise in statistical tools for process and test method design and evaluation, including Design of Experiments (DOE), Statistical Process Control (SPC), Regression Analysis, Analysis of Variance (ANOVA)

• Experience with ISO 13485, ISO 9001, and/or cGMP in Test Method Development, Quality Assurance, Quality Systems, Operations, or related fields

• Education and Experience

• PhD in molecular biology/enzymology or related fields with 0 - 5+ years of demonstrated experience in test method design

• Note: This description is intended to describe the general content of and requirements for the performance of this role. It is not intended to be an exhaustive list of qualifications, responsibilities, or working conditions.