Process Development Scientist I

Watchmaker Genomics•Boulder, CO, CO

6d•$80,000 - $95,000•Onsite

About The Position

Watchmaker Genomics is hiring a full-time, onsite Process Development Scientist I for its R&D department in Boulder, Colorado. Reporting to the Senior Engineer II on the Process Development team, the scientist will design, optimize, and transfer robust formulation and manufacturing processes for new and existing molecular biology products. The role serves as technical lead on assigned design transfer, process improvement, and validation projects. The position offers technical ownership of projects moving new products from R&D into production and maintaining reliable performance of on-market products. The scientist will work with R&D, Manufacturing, Quality, and Product Management as the company scales across Boulder and Cape Town. The work is onsite/in-office, with flexibility to work from home one day per week. Local candidates are preferred. Applicants should have a bachelor’s degree and at least eight years of industry experience, a master’s degree and at least six years of industry experience, or a PhD with no industry experience for Research Scientist I. Applicants with more experience are welcome. Experience in biotech and a start-up environment is highly desirable. The base compensation starts at $80,000–$95,000, plus bonus and equity; actual pay is adjusted based on skills and experience. Employees are eligible for Flexible Time Off, holidays, employer-paid portions of medical, dental, vision, and life/AD&D coverage, buy-up options for medical, dental, and vision plans, an employee assistance program, paid parental leave, and a 401(k) plan with a 4% employer match.

Requirements

Bachelor’s degree with at least 8 years of industry experience, master’s degree with at least 6 years of industry experience, or PhD; the posting specifies no industry experience for a PhD for Research Scientist I.
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 or volumetric measurements, spectrophotometry, fluorometry, pH or conductivity, osmolality or freezing point depression, viscometry, and 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 level of accuracy in documentation, record-keeping, and reporting.
Experience in biotech and a start-up environment is highly desirable.
Applicants must submit a letter of motivation and a resume or curriculum vitae in PDF format. Applications without a letter of motivation will not be considered.
Applicants will be asked whether they are currently eligible to work in the United States and whether they will require visa sponsorship now or in the future.

Nice To Haves

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 designing a stable, capable process.
Proficiency with statistical tools and methods, including DOE, ANOVA, regression, and capability analysis; 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.
More experience than the stated minimum is welcome.
Local candidates are preferred.

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 evaluating and implementing 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, leading execution from transfer planning through training and transfer assessments.
Plan and execute process validation and related validation activities in partnership with Validation and Quality.
Lead troubleshooting of process and product performance issues using structured, data-driven approaches.
Lead root cause investigations for assigned projects 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 new product development and continuous improvement projects.
Plan and prioritize 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 the 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.
Perform other similar duties as required from time to time.