Senior Process Development Associate

Position: Senior Process Development Associate

Focus Area: Enzyme Manufacturing

Department: Process Development

Position Type: Full-Time Employee

Location: Boulder, CO, onsite

Experience: Bachelor’s degree (ideally in Biochemistry or Biochemical Engineering) + min of 5 years relevant experience in process development or bioprocess manufacturing; or Masters and 3 years.

Watchmaker Genomics is a global life science company based in Boulder, Colorado with an R&D and Production facility in Cape Town, South Africa. Our team is passionate about innovation and values collaboration, creativity, and scientific rigor.

We believe that the intersection of biology, engineering, and computer science presents exciting opportunities for developing novel technologies that promote research and improve human health. Watchmaker Genomics specializes in the design, development, and production of DNA- and RNA-modifying enzymes that enable high-growth applications in genomics, molecular diagnostics, and personalized medicine.

Position Summary

We are seeking a Senior Process Development Associate to join our Process Development team in Boulder, CO.

As part of the Process Development team, you will apply your process engineering expertise to design and transfer recombinant protein expression and purification processes. Reporting to a Senior Scientist, you will contribute directly to the development and delivery of high-quality, innovative products for our customers. In this highly collaborative role, you will work closely with teams across R&D, Production, IT, and Quality Assurance at our global sites.

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:

• With guidance, building and optimizing recombinant protein expression and purification processes for use in routine manufacturing.
• Contributing to robust, rigorous experimental design and execution for the development and testing of new processes and comprehensively documenting outcomes.
• Identifying and documenting process risks, assessing potential impacts, and developing appropriate mitigations.
• Identifying critical process parameters (CPPs) to ensure critical-to-quality attributes (CQAs) are consistently achieved.
• 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.
• Having a working understanding of the ISO 13485 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 for operators on new or revised procedures.

Skills and Requirements

Specific skills and requirements include:

• Principles of recombinant protein expression and protein purification, including chromatography.
• Basic protein biochemistry (e.g., physical properties, experimental methods, enzyme kinetics, etc.)
• Predisposition for systems-level thinking, as applied to designing and implementing robust, scalable processes for enzyme manufacturing.
• Demonstrated scientific excellence in technical work, written communication, and presenting technical information to groups with various scientific backgrounds.
• Adaptability, curiosity, and the 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 with the ability to effectively communicate across multi-level,…