Position: Process Development Scientist I

Position Type: Full-Time Employee

Department: R&D

Location: Boulder, CO, onsite

Experience: Minimum of BS/BA with 8 yrs industry experience, MS with 6 yrs, PhD with no industry experience for Research Scientist I. Open to applicants with more experience.

Position Summary

Watchmaker is inviting applications for the full-time position of Process Development Scientist I based in Boulder, CO, reporting to the Senior Engineer II on the Process Development team. This role will design, optimize, and transfer robust formulation and manufacturing processes for new and existing molecular biology products, serving as technical lead on assigned design transfer, process improvement, and validation projects.

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.

The position provides an opportunity to take technical ownership of projects that move new products from R&D into production and keep on-market products performing reliably, working closely with R&D, Manufacturing, Quality, and Product Management in a company scaling across sites in Boulder and Cape Town.

Responsibilities

Process Development & Execution

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 sets using appropriate statistical methods, draw technical conclusions, and recommend next steps to project teams
Define and characterize critical process parameters and provide the technical rationale for process ranges and specifications
Lead the 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 the evaluation and implementation of new methods, equipment, or technologies
Contribute to process characterization and process monitoring to establish process capability metrics

Technical Transfer & Manufacturing Support

Own the design transfer of assigned products or processes into manufacturing once project scope is defined, leading execution from transfer planning through training and transfer assessments
Plan and execute process validation and related validation activities for assigned processes in partnership with Validation and Quality
Lead troubleshooting of process and product performance issues on assigned products and processes using structured, data-driven approaches
Lead root cause investigations for assigned projects, and drive NCR and CAPA actions through to effective resolution
Identify, propose, and implement process improvements in partnership with cross-functional teams

Collaboration & Project Leadership

Act as the PD technical point of contact for R&D, Manufacturing, Quality, and Product Management on assigned new product development (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

Documentation & Quality Systems

Author and review technical documentation including protocols, reports, work instructions, and batch records
Perform risk assessments (e.g., FMEA) and requirements definition for assigned projects
Ensure work is conducted in accordance with internal QMS and applicable standards, and identify gaps in existing documentation or practices
Develop and deliver training for new or updated processes

Laboratory Operations

Define equipment and material requirements for assigned projects and support qualification of new equipment
Ensure laboratory readiness, organization, and calibration status in support of project timelines