{"schemaVersion":"jobsearcher.job.v1","id":"7f992369ec3bfb381a784541","url":"https://jobsearcher.com/jobs/7f992369ec3bfb381a784541","canonicalUrl":"https://jobsearcher.com/jobs/7f992369ec3bfb381a784541","title":"Process Development Scientist I","description":"Position: Process Development Scientist IFocus Area: SystemsPosition Type: Full-Time EmployeeDepartment: R&DLocation: Boulder, CO, onsiteExperience: Minimum of BS/BA with 5+ yrs industry experience, or minimum of MS with 3+ years of industry experience, or minimum of PhD + 0 years industry experience.Watchmaker Genomics is a global life science company based in Boulder, Colorado with an R&D and Production facility in Cape Town, South Africa. Our team is passionate about innovation and values collaboration, creativity, and scientific rigor.We believe that the intersection of biology, engineering, and computer science presents exciting opportunities for developing novel technologies that promote research and improve human health. Watchmaker Genomics specializes in the design, development, and production of DNA- and RNA-modifying enzymes that enable high-growth applications in genomics, molecular diagnostics, and personalized medicine.Position Summary Watchmaker is inviting applications for the full-time position of Process Development Scientist I based in Boulder, CO, USA. The successful candidate will thrive in a dynamic, fast-paced working environment and contribute directly to our company culture and success. This is an onsite/in-office position with flexibility to work from home one day a week.This role will support the successful transfer of new products into manufacturing while contributing to the continuous improvement and lifecycle management of existing products and operational processes. The Scientist I will work cross-functionally with Process Development, R&D, Quality Assurance, Operations, Supply Chain, and Product Management teams to support design transfer activities in compliance with ISO 13485 and internal quality system requirements.This position is focused on two core areas: (1) supporting design transfer and new product development activities, and (2) driving process improvement and change management initiatives across product lifecycle and operational workflows. The Scientist I will help coordinate projects, maintain process documentation, improve process standardization, and support scalable systems that enable efficient product launches and ongoing product support. This role is well suited for an organized and collaborative scientist with strong project coordination, technical writing, and problem-solving skills who is interested in process systems, quality-driven product development, and operational excellence in a regulated biotechnology environment.ResponsibilitiesDesign Transfer & New Product Development (NPD)Support and execute on design transfer deliverables for new products in compliance with ISO 13485 and internal quality system requirementsCoordinate cross-functional and cross-site technical transfer activities between global manufacturing and development sitesSupport implementation of Quality by Design (QbD) principles, including alignment of critical quality attributes (CQAs) with critical process parameters (CPPs)Support manufacturing readiness activities including pilot builds, material transfers, and production setup coordinationContribute to raw material qualification & setup, process validation, equipment qualification (IQ/OQ/PQ), and associated change management activitiesParticipate in product launch planning, product configuration, and pre-launch operational coordinationChange Control, Lifecycle Management & Continuous ImprovementSupport change control and product lifecycle management activities for existing products and processesHelp identify process gaps and implement improvements across new product development, design transfer, and operational workflowsDrive continuous improvement initiatives related to raw material qualification, shelf-life extension programs, and process standardizationContribute to development and maintenance of scalable Process Development workflows, templates, and best practicesSupport data-driven process monitoring, trending, and performance evaluation activitiesParticipate in non-conformance investigations, root cause analyses, risk assessments, and CAPA activitiesProject Coordination, Documentation & CommunicationSupport Process Development project execution through timeline tracking, meeting coordination, and stakeholder status updatesAuthor, maintain and organize controlled documentation including process maps, work instructions, change controls, and FMEAsDevelop training materials and support training for new and updated processesCommunicate process updates, risks, and project status clearly with technical and non-technical stakeholdersCollaborate globally with cross-functional teams to support Process Development and operational initiativesSupport additional Process Development activities and strategic initiatives as assignedPlease note: The above responsibilities are not exhaustive and other similar duties may be required from time to time.Skills and RequirementsThe following skills and experience are requirements for the position:Understanding of design transfer, change control, and product lifecycle management within a QMSFamiliarity with ISO 13485 and regulated quality systemsExperience supporting cross-functional projects and process improvement initiativesStrong technical writing and controlled documentation skillsExperience with quality tools including CAPA, root cause analysis, change controls, deviations, and FMEAFamiliarity with process validation and equipment qualification (IQ/OQ/PQ)Strong organizational, analytical, and problem-solving skillsEffective communication and collaboration skillsProficiency with Microsoft Office and/or Google WorkspaceFamiliarity with business systems such as ERP, MES, QMS, or inventory management platformsPreferred skills and experience:Experience in biotechnology, diagnostics, or regulated manufacturing environmentsExperience supporting design transfer or technical transfer activitiesFamiliarity with Quality by Design (QbD), including CQAs and CPPsExperience with molecular biology or biochemistry techniques such as PCR, protein purification, enzymology, or NGSExperience with new product development and post-market product changesKnowledge of statistical and process improvement tools such as DOE, ANOVA, Lean, Six Sigma, or KaizenExperience with stability studies, shelf-life extensions, or raw material qualificationFamiliarity with project management tools such as Smartsheet, Jira, Monday.com, or MS ProjectExperience working across multiple sites or global teamsTraining or certification in project management, quality systems, or process improvement methodologiesEducation and ExperiencePhD in life science or engineering and a minimum of 0+ years of industry experience;MS and a minimum of 3+ yrs industry experience; orBS and a minimum of 5+ yrs industry experienceCompensationThe base compensation for the Process Development Scientist I role starts at $80,000 - 90,000 + bonus + equity; actual pay will be adjusted based on skills and experience. Employees are eligible for Flexible Time Off, Holidays, employer covers 75% of base medical plan with buy-up options, EAP (employee assistance program), employer paid dental with a buy-up option, employer paid vision, employer paid $25,000 life/AD&D policy, paid parental leave, and a 401(k) retirement plan with a 4% match.Application Requirements To apply for the position, please submit the following in a PDF format on watchmakergenomics.com:Letter of motivation (upload where it says cover letter)Resume or Curriculum vitae, highlighting relevant qualifications and experienceApplications without a Letter of Motivation will not be considered.Applications will be accepted on a rolling basis and the position will remain open until filled; however, early submission is encouraged as review will begin immediately.If selected to participate in the interview process, the names and contact information of three professional references who are able to assess your suitability for the position in terms of the specified requirements will be requested.*** NO RECRUITMENT AGENCIES PLEASEWe are only accepting direct applications for this position. We are not working with external recruiters or agencies at this time. Unsolicited resumes or candidate submissions from third-party recruiters will not be considered and will be deemed the property of Watchmaker Genomics.*** WE ARE AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYERWatchmaker Genomics is committed to being an equal opportunity employer and creating a culturally diverse environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics as protected by applicable law.All applicants will be asked if currently eligible to work in the United States of America; and if now or in the future will require visa sponsorship to continue working in the United States.This position may be subject to pre-employment checks, including driving history check, drug screening and a background check for any convictions directly related to its duties and responsibilities. All pre-employment checks will comply with all applicable federal, state, and local laws.","company":"Watchmaker Genomics","rawCompany":"watchmaker genomics","city":"Boulder","state":"CO","isRemote":false,"isActive":false,"createdAt":"2026-05-24T14:46:16.510Z","occupations":[{"code":"11-9121.00","title":"Natural Sciences Managers","slug":"natural-sciences-managers"},{"code":"19-1029.02","title":"Molecular and Cellular Biologists","slug":"molecular-and-cellular-biologists"},{"code":"19-1029.00","title":"Biological Scientists, All Other","slug":"biological-scientists-all-other"}],"industries":[{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Development Scientist I","description":"Position: Process Development Scientist IFocus Area: SystemsPosition Type: Full-Time EmployeeDepartment: R&DLocation: Boulder, CO, onsiteExperience: Minimum of BS/BA with 5+ yrs industry experience, or minimum of MS with 3+ years of industry experience, or minimum of PhD + 0 years industry experience.Watchmaker Genomics is a global life science company based in Boulder, Colorado with an R&D and Production facility in Cape Town, South Africa. Our team is passionate about innovation and values collaboration, creativity, and scientific rigor.We believe that the intersection of biology, engineering, and computer science presents exciting opportunities for developing novel technologies that promote research and improve human health. Watchmaker Genomics specializes in the design, development, and production of DNA- and RNA-modifying enzymes that enable high-growth applications in genomics, molecular diagnostics, and personalized medicine.Position Summary Watchmaker is inviting applications for the full-time position of Process Development Scientist I based in Boulder, CO, USA. The successful candidate will thrive in a dynamic, fast-paced working environment and contribute directly to our company culture and success. This is an onsite/in-office position with flexibility to work from home one day a week.This role will support the successful transfer of new products into manufacturing while contributing to the continuous improvement and lifecycle management of existing products and operational processes. The Scientist I will work cross-functionally with Process Development, R&D, Quality Assurance, Operations, Supply Chain, and Product Management teams to support design transfer activities in compliance with ISO 13485 and internal quality system requirements.This position is focused on two core areas: (1) supporting design transfer and new product development activities, and (2) driving process improvement and change management initiatives across product lifecycle and operational workflows. The Scientist I will help coordinate projects, maintain process documentation, improve process standardization, and support scalable systems that enable efficient product launches and ongoing product support. This role is well suited for an organized and collaborative scientist with strong project coordination, technical writing, and problem-solving skills who is interested in process systems, quality-driven product development, and operational excellence in a regulated biotechnology environment.ResponsibilitiesDesign Transfer & New Product Development (NPD)Support and execute on design transfer deliverables for new products in compliance with ISO 13485 and internal quality system requirementsCoordinate cross-functional and cross-site technical transfer activities between global manufacturing and development sitesSupport implementation of Quality by Design (QbD) principles, including alignment of critical quality attributes (CQAs) with critical process parameters (CPPs)Support manufacturing readiness activities including pilot builds, material transfers, and production setup coordinationContribute to raw material qualification & setup, process validation, equipment qualification (IQ/OQ/PQ), and associated change management activitiesParticipate in product launch planning, product configuration, and pre-launch operational coordinationChange Control, Lifecycle Management & Continuous ImprovementSupport change control and product lifecycle management activities for existing products and processesHelp identify process gaps and implement improvements across new product development, design transfer, and operational workflowsDrive continuous improvement initiatives related to raw material qualification, shelf-life extension programs, and process standardizationContribute to development and maintenance of scalable Process Development workflows, templates, and best practicesSupport data-driven process monitoring, trending, and performance evaluation activitiesParticipate in non-conformance investigations, root cause analyses, risk assessments, and CAPA activitiesProject Coordination, Documentation & CommunicationSupport Process Development project execution through timeline tracking, meeting coordination, and stakeholder status updatesAuthor, maintain and organize controlled documentation including process maps, work instructions, change controls, and FMEAsDevelop training materials and support training for new and updated processesCommunicate process updates, risks, and project status clearly with technical and non-technical stakeholdersCollaborate globally with cross-functional teams to support Process Development and operational initiativesSupport additional Process Development activities and strategic initiatives as assignedPlease note: The above responsibilities are not exhaustive and other similar duties may be required from time to time.Skills and RequirementsThe following skills and experience are requirements for the position:Understanding of design transfer, change control, and product lifecycle management within a QMSFamiliarity with ISO 13485 and regulated quality systemsExperience supporting cross-functional projects and process improvement initiativesStrong technical writing and controlled documentation skillsExperience with quality tools including CAPA, root cause analysis, change controls, deviations, and FMEAFamiliarity with process validation and equipment qualification (IQ/OQ/PQ)Strong organizational, analytical, and problem-solving skillsEffective communication and collaboration skillsProficiency with Microsoft Office and/or Google WorkspaceFamiliarity with business systems such as ERP, MES, QMS, or inventory management platformsPreferred skills and experience:Experience in biotechnology, diagnostics, or regulated manufacturing environmentsExperience supporting design transfer or technical transfer activitiesFamiliarity with Quality by Design (QbD), including CQAs and CPPsExperience with molecular biology or biochemistry techniques such as PCR, protein purification, enzymology, or NGSExperience with new product development and post-market product changesKnowledge of statistical and process improvement tools such as DOE, ANOVA, Lean, Six Sigma, or KaizenExperience with stability studies, shelf-life extensions, or raw material qualificationFamiliarity with project management tools such as Smartsheet, Jira, Monday.com, or MS ProjectExperience working across multiple sites or global teamsTraining or certification in project management, quality systems, or process improvement methodologiesEducation and ExperiencePhD in life science or engineering and a minimum of 0+ years of industry experience;MS and a minimum of 3+ yrs industry experience; orBS and a minimum of 5+ yrs industry experienceCompensationThe base compensation for the Process Development Scientist I role starts at $80,000 - 90,000 + bonus + equity; actual pay will be adjusted based on skills and experience. Employees are eligible for Flexible Time Off, Holidays, employer covers 75% of base medical plan with buy-up options, EAP (employee assistance program), employer paid dental with a buy-up option, employer paid vision, employer paid $25,000 life/AD&D policy, paid parental leave, and a 401(k) retirement plan with a 4% match.Application Requirements To apply for the position, please submit the following in a PDF format on watchmakergenomics.com:Letter of motivation (upload where it says cover letter)Resume or Curriculum vitae, highlighting relevant qualifications and experienceApplications without a Letter of Motivation will not be considered.Applications will be accepted on a rolling basis and the position will remain open until filled; however, early submission is encouraged as review will begin immediately.If selected to participate in the interview process, the names and contact information of three professional references who are able to assess your suitability for the position in terms of the specified requirements will be requested.*** NO RECRUITMENT AGENCIES PLEASEWe are only accepting direct applications for this position. We are not working with external recruiters or agencies at this time. Unsolicited resumes or candidate submissions from third-party recruiters will not be considered and will be deemed the property of Watchmaker Genomics.*** WE ARE AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYERWatchmaker Genomics is committed to being an equal opportunity employer and creating a culturally diverse environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics as protected by applicable law.All applicants will be asked if currently eligible to work in the United States of America; and if now or in the future will require visa sponsorship to continue working in the United States.This position may be subject to pre-employment checks, including driving history check, drug screening and a background check for any convictions directly related to its duties and responsibilities. All pre-employment checks will comply with all applicable federal, state, and local laws.","datePosted":"2026-05-24T14:46:16.510Z","dateModified":"2026-05-24T14:46:16.510Z","hiringOrganization":{"@type":"Organization","name":"Watchmaker Genomics","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Boulder","addressRegion":"CO","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"7f992369ec3bfb381a784541"},"url":"https://jobsearcher.com/jobs/7f992369ec3bfb381a784541"}}