Process Development Scientist I

Watchmaker Genomics•Boulder, CO

5d•Onsite

About The Position

Watchmaker Genomics is hiring a full-time Process Development Scientist I for its R&D department in Boulder, Colorado. The position reports to the Senior Engineer II on the Process Development team and is onsite, with flexibility to work from home one day per week. The scientist will design, optimize, and transfer robust formulation and manufacturing processes for new and existing molecular biology products, and serve as the technical lead on assigned design transfer, process improvement, and validation projects. The role provides technical ownership of work moving products from R&D into production and supporting reliable performance of products already on the market. It involves close collaboration with R&D, Manufacturing, Quality, and Product Management as the company scales across Boulder and Cape Town. The successful candidate will independently conduct process and formulation development, lead technical transfers and validation work, troubleshoot performance issues, and drive process improvements. They will also contribute technical guidance, project coordination, documentation, quality-system compliance, and laboratory readiness. The position suits someone able to work in a dynamic, fast-paced environment and manage multiple projects with minimal supervision. The stated experience qualifications are a minimum of a BS/BA and eight years of industry experience, an MS and six years, or a PhD with no industry experience (the posting refers to this last qualification as being for Research Scientist I). Candidates with more experience are welcome. Biotech and startup-environment experience are highly desirable. Compensation starts at $80,000–$95,000, plus bonus and equity, with actual pay adjusted based on skills and experience.

Requirements

BS/BA with at least 8 years of industry experience, MS with at least 6 years, or PhD with no industry experience (the posting labels this last qualification as being for Research Scientist I); candidates with more experience are welcome.
Demonstrated ability to independently design, execute, and interpret experiments with scientific rigor.
Hands-on experience with molecular biology techniques such as PCR, qPCR, electrophoresis, nucleic acid quantification and fragment analysis, and NGS workflows.
Experience with reagent or enzyme formulation and associated analytical measurements, including gravimetric/volumetric measurement, spectrophotometry, fluorometry, pH/conductivity, osmolality/freezing point depression, viscometry, or densitometry.
Experience designing, characterizing, and implementing processes in a manufacturing or regulated environment, including scale-up or technical transfer.
Strong problem-solving skills and experience leading root cause investigations to resolution.
Ability to translate data into clear technical recommendations for audiences with varied scientific backgrounds.
Strong organizational skills and ability to manage multiple projects and priorities with minimal supervision.
Strong interpersonal skills and ability to work effectively as a team member.
High accuracy in documentation, record-keeping, and reporting.

Nice To Haves

Biotech experience and experience in a startup environment are highly desirable.
Experience developing and optimizing automated liquid-handling methods for reagent preparation, formulation, or filling workflows.
Experience validating spreadsheets in a regulated environment, including documented verification of calculations and access controls.
Working understanding of process validation (IQ/OQ/PQ/PPQ) and how to design a stable, capable process.
Proficiency with statistical tools and methods such as DOE, ANOVA, regression, and capability analysis, using JMP, Minitab, or similar.
Working knowledge of quality systems such as ISO 13485, including NCR, CAPA, and change-control processes.
Experience training or providing technical guidance to junior staff.

Responsibilities

Independently design and execute formulation and process development studies, including DOE-based experiments, to support scale-up, optimization, and technical transfer.
Analyze and interpret complex data using appropriate statistical methods, draw technical conclusions, and recommend next steps to project teams.
Define and characterize critical process parameters and provide technical rationale for process ranges and specifications.
Lead translation of lab-scale processes into robust, manufacturing-ready workflows for assigned projects or workstreams.
Lead qualification and implementation of new or alternate raw materials for assigned products.
Contribute to evaluation and implementation of new methods, equipment, or technologies.
Contribute to process characterization and monitoring to establish process capability metrics.
Own design transfer of assigned products or processes into manufacturing, from transfer planning through training and transfer assessments.
Plan and execute process validation and related activities with Validation and Quality.
Lead troubleshooting of process and product performance issues using structured, data-driven approaches.
Lead root cause investigations and drive NCR and CAPA actions through effective resolution.
Identify, propose, and implement process improvements with cross-functional teams.
Serve as the Process Development technical point of contact for R&D, Manufacturing, Quality, and Product Management on assigned NPD and continuous-improvement projects.
Plan and prioritize own work and coordinate supporting team members to meet project milestones.
Present experimental results, technical recommendations, and risks clearly to cross-functional teams and stakeholders.
Provide technical guidance and training to Research Associates.
Author and review technical documentation, including protocols, reports, work instructions, and batch records.
Perform risk assessments such as FMEA and define requirements for assigned projects.
Ensure work follows internal QMS and applicable standards, and identify gaps in documentation or practices.
Develop and deliver training for new or updated processes.
Define equipment and material requirements and support qualification of new equipment.
Ensure laboratory readiness, organization, and calibration status in support of project timelines.
Model and promote safe laboratory practices.