Senior Process Development Associate

Watchmaker Genomics•Boulder, CO, CO

7d•$75,000 - $85,000•Onsite

About The Position

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.

Requirements

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, cross-functional teams.
Excellent organizational skills and attention to detail.
Strong personal task management skills and a high level of self-motivation.
Excellent written and verbal communication skills.
Technical understanding of and/or experience with: PCR and next-generation sequencing (NGS) techniques.
Risk management and hazard analysis frameworks or tools, such as Failure Modes and Effects Analysis (FMEA).
Assessing analytical measurement methods and 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), t-tests).
ISO 9001 and/or ISO 13485 standards or operating within a structured quality management system (QMS).

Responsibilities

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.