Process Development Scientist

Position: Scientist Process Development

Position Type: Full-Time Employee

Location: Salt River, Cape Town, onsite

Experience: Minimum of BSc/BEng with 5+ yrs industry experience, or minimum of MSc with 3+ years of industry experience, or minimum of PhD + 0 years industry experience.

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 rigour. 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 personalised medicine.

We are seeking a Process Development Scientist/Engineer to join our team in Cape Town, South Africa. This role will support the successful transfer of new products into manufacturing while contributing to the continuous improvement and lifecycle management of existing products and operational processes. The incumbentI will work cross-functionally with Process Development, R&D, Quality Assurance, Operations, Supply Chain, and Product Management teams to support design transfer activities in compliance with ISO 13485 and internal quality system requirements.

Responsibilities

Design Transfer & New Product Development (NPD)

Support and execute on design transfer deliverables for new products in compliance with ISO 13485 and internal quality system requirements

Coordinate cross-functional and cross-site technical transfer activities between global manufacturing and development sites

Support implementation of Quality by Design (QbD) principles, including alignment of critical quality attributes (CQAs) with critical process parameters (CPPs)

Support manufacturing readiness activities including pilot builds, material transfers, and production setup coordination

Contribute to raw material qualification & setup, process validation, equipment qualification (IQ/OQ/PQ), and associated change management activities

Participate in product launch planning, product configuration, and pre-launch operational coordination

Change Control, Lifecycle Management & Continuous Improvement

Support change control and product lifecycle management activities for existing products and processes

Help identify process gaps and implement improvements across new product development, design transfer, and operational workflows

Drive continuous improvement initiatives related to raw material qualification, shelf-life extension programs, and process standardization

Contribute to development and maintenance of scalable Process Development workflows, templates, and best practices

Support data-driven process monitoring, trending, and performance evaluation activities

Participate in non-conformance investigations, root cause analyses, risk assessments, and CAPA activities

Project Coordination, Documentation & Communication

Support Process Development project execution through timeline tracking, meeting coordination, and stakeholder status updates

Author, maintain and organize controlled documentation including process maps, work instructions, change controls, and FMEAs

Develop training materials and support training for new and updated processes

Communicate process updates, risks, and project status clearly with technical and non-technical stakeholders

Collaborate globally with cross-functional teams to support Process Development and operational initiatives

Support additional Process Development activities and strategic initiatives as assigned

The following skills and experience are requirements for the position

Understanding of design transfer, change control, and product lifecycle management within a QMS

Familiarity with ISO 13485 and regulated quality systems

Experience supporting cross-functional projects and process improvement initiatives

Strong technical writing and controlled documentation skills

Experience with quality tools including CAPA, root cause analysis, change controls, deviations, and FMEA

Familiarity with process validation and equipment qualification (IQ/OQ/PQ)

Strong organizational, analytical, and problem-solving skills

Effective communication and collaboration skills

Proficiency with Microsoft Office and/or Google Workspace

Familiarity with business systems such as ERP, MES, QMS, or inventory management platforms

Preferred skills and experience

Experience in biotechnology, diagnostics, or regulated manufacturing environments

Experience supporting design transfer or technical transfer activities

Familiarity with Quality by Design (QbD), including CQAs and CPPs

Experience with molecular biology or biochemistry techniques such as PCR, protein purification, enzymology, or NGS

Experience with new product development and post-market product changes

Knowledge of statistical and process improvement tools such as DOE, ANOVA, Lean, Six Sigma, or Kaizen

Experience with stability studies, shelf-life extensions, or raw material qualification

Familiarity with project management tools such as Smartsheet, Jira, Monday.com, or MS Project

Experience working across multiple sites or global teams

Training or certification in project management, quality systems, or process improvement methodologies

Education and Experience

PhD in life science or engineering and a minimum of 3+ years of industry experience; or

MS and a minimum of 6+ yrs industry experience; or

BS and a minimum of 8+ yrs industry experience

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. We will also request a current payslip.

To ensure your application is considered, please submit it by Friday, 7 August 2026. 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.

NO RECRUITMENT AGENCIES PLEASE

We are only accepting direct applications for this position. We are not working with external recruiters or agencies at this time. Unsolicited resumes or candidate submissions from third-party recruiters will not be considered and will be deemed the property of Watchmaker Genomics

All applicants will be asked if currently eligible to work in South Africa; and if now or in the future will require visa sponsorship to continue working in South Africa.

This position may be subject to pre-employment checks, including driving history check, drug screening and a background check for any convictions directly related to its duties and responsibilities. All pre-employment checks will comply with all applicable laws.