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 *** SOUTH AFRICA - WE ARE AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER Watchmaker Genomics is committed to being an equal opportunity employer and creating a culturally diverse environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics as protected by applicable law. 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.