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

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 expertise in process engineering to design and transfer recombinant protein expression and purification processes, reporting to one of our Senior Scientists. 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 sit

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.

• 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.

• 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…