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.

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 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

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:

• 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.