Process Development Scientist I
About The Position
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.
Requirements
- Understanding of design transfer, change control, and product lifecycle management within a QMS
- Familiarity with ISO 13485 and regulated quality systems
- Experience supporting cross-functional projects and process improvement initiatives
- Strong technical writing and controlled documentation skills
- Experience with quality tools including CAPA, root cause analysis, change controls, deviations, and FMEA
- Familiarity with process validation and equipment qualification (IQ/OQ/PQ)
- Strong organizational, analytical, and problem-solving skills
- Effective communication and collaboration skills
- Proficiency with Microsoft Office and/or Google Workspace
- Familiarity with business systems such as ERP, MES, QMS, or inventory management platforms
Nice To Haves
- Experience in biotechnology, diagnostics, or regulated manufacturing environments
- Experience supporting design transfer or technical transfer activities
- Familiarity with Quality by Design (QbD), including CQAs and CPPs
- Experience with molecular biology or biochemistry techniques such as PCR, protein purification, enzymology, or NGS
- Experience with new product development and post-market product changes
- Knowledge of statistical and process improvement tools such as DOE, ANOVA, Lean, Six Sigma, or Kaizen
- Experience with stability studies, shelf-life extensions, or raw material qualification
- Familiarity with project management tools such as Smartsheet, Jira, Monday.com, or MS Project
- Experience working across multiple sites or global teams
- Training or certification in project management, quality systems, or process improvement methodologies
Responsibilities
- Support and execute on design transfer deliverables for new products in compliance with ISO 13485 and internal quality system requirements
- Coordinate cross-functional and cross-site technical transfer activities between global manufacturing and development sites
- Support 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 coordination
- Contribute to raw material qualification & setup, process validation, equipment qualification (IQ/OQ/PQ), and associated change management activities
- Participate in product launch planning, product configuration, and pre-launch operational coordination
- Support change control and product lifecycle management activities for existing products and processes
- Help identify process gaps and implement improvements across new product development, design transfer, and operational workflows
- Drive continuous improvement initiatives related to raw material qualification, shelf-life extension programs, and process standardization
- Contribute to development and maintenance of scalable Process Development workflows, templates, and best practices
- Support data-driven process monitoring, trending, and performance evaluation activities
- Participate in non-conformance investigations, root cause analyses, risk assessments, and CAPA activities
- Support Process Development project execution through timeline tracking, meeting coordination, and stakeholder status updates
- Author, maintain and organize controlled documentation including process maps, work instructions, change controls, and FMEAs
- Develop training materials and support training for new and updated processes
- Communicate process updates, risks, and project status clearly with technical and non-technical stakeholders
- Collaborate globally with cross-functional teams to support Process Development and operational initiatives
- Support additional Process Development activities and strategic initiatives as assigned
Benefits
- 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
- 401(k) retirement plan with a 4% match
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
