Process Development Associate (Formulations)

watchmakergenomics; Cape Town; On-site; ZAR 480,000 - 640,000; Full time

Job summary

Watchmaker Genomics in Cape Town, South Africa, is seeking a Process Development Associate to join the Formulations focus area. This full-time on-site role requires a BSc/BEng in Process/Chemical Engineering with 0–2+ years of related experience.

You will collaborate with R&D, Production, IT and Quality Assurance to design, transfer, and optimize reagent manufacturing processes. You will translate product requirements into scalable processes, support product transfers from R&D to manufacturing,

Qualifications

• Minimum BSc/BEng in Process/Chemical Engineering with 0-2+ years relevant experience in process engineering or biotechnology.
• Experience applying process engineering to design and transfer reagent manufacturing processes.
• Familiarity with ISO13485 and SOPs is advantageous but not mandatory.

Responsibilities

• Translate product requirements into process specifications and develop scalable processes.
• Support transfer of new products from R&D to manufacturing and provide ongoing process updates.
• Document outcomes, write work instructions and batch templates for reproducibility.
• Assist in validation of processes, equipment and computer systems, and material qualification.
• Identify CPPs/CQAs and mitigate process risks through data trending and experimentation.

Skills

Systems thinking

Technical excellence

Analytical thinking

Adaptability

Curiosity

Problem solving

Cross-functional collaboration

Attention to detail

Self-motivation

Excellent communication

Education

BSc/BEng in Process/Chemical Engineering

Job description

Position: Process Development Associate

Focus Area: Formulations

Position Type: Full-Time Employee

Location: Cape Town, South Africa (on-site)

Experience: Minimum BSc/BEng in Process/Chemical Engineering with 0 - 2+ years relevant experience in process engineering or biotechnology

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 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.

Position Summary

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

As part of the Process Development team, you will apply your expertise in process engineering to design and transfer reagent manufacturing processes. You will contribute directly in delivering high-quality, innovative 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 manufacturing. This involves translating product requirements into process specifications and developing efficient, scalable processes to meet these needs. After product launch, the team provides ongoing support for process updates to maintain product quality.

Specific responsibilities include:

• Identifying critical process parameters (CPPs) that ensure critical-to-quality attributes (CQAs) are consistently achieved.


• Assisting in developing or adapting processes to meet CPPs by investigating new methods, equipment and controls, and confirming suitability through experimentation.


• Identifying opportunities for process streamlining, standardization, and alignment with industry best practices.


• Planning and executing assigned project deliverables and proactively communicating status and outcomes.


• Contributing to process, equipment, and computer systems validation, as well as material qualification, by establishing clear, testable specifications based on CPPs and CQAs, along with associated experimental planning.


• Identifying and documenting process risks, assessing potential impacts, and developing appropriate mitigations.


• Contributing to robust, rigorous experimental design for the development and testing of new processes and comprehensively document outcomes.


• Having a working understanding of the ISO13485 standard and internal standard operating procedures (SOPs) to effectively apply these principles.


• Supporting on-market products by investigating process-related issues through data trending, analysis, or experimentation.


• Authoring and revising work instructions, batch record templates, and other production-facing documentation that are clear and concise to ensure reproducible results.


• Preparing training materials and conducting classroom and on-the-job training of operators on new or revised procedures.

Required skills

• Predisposition for systems-level thinking, as applied to designing and implementing robust, scalable processes for reagent manufacturing.


• Demonstrated scientific excellence in technical work, written communication and presenting technical information to groups with various scientific backgrounds.


• Adaptability, curiosity and ability to grasp and apply new concepts quickly.


• 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

Technical understanding of and/or experience with:

• PCR, next-generation sequencing (NGS) techniques, and basic protein biochemistry (e.g., physical properties, experimental methods, enzyme kinetics, etc.).


• Mid-scale life science reagent manufacturing and scale-up.


• Analytical measurement methods and assessing process capabilities, using statistical techniques such as Measurement Systems Analysis (MSA) or Gauge Repeatability & Reproducibility (Gauge R&R).


• Designing and monitoring processes using statistical methods such as Design of Experiments (DOE) and Statistical Process Control (SPC).


• General statistical techniques such as regression analysis and significance testing (e.g., Analysis of Variance (ANOVA),