Process Development Scientist I

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
• Model and promote safe laboratory practices

Please note: The above responsibilities are not exhaustive and other similar duties may be required from time to time.

Skills and Requirements

The candidate should have experience in biotech and a start-up environment are highly desirable.

The following skills and experience are requirements for the position:

• Demonstrated ability to independently design, execute, and interpret experiments with scientific rigor.
• Hands-on experience with molecular biology techniques (PCR, qPCR, electrophoresis, nucleic acid quantification and fragment analysis, NGS workflows, etc.).
• Experience with reagent or enzyme formulation and associated analytical measurements (gravimetric/volumetric, spectrophotometry, fluorometry, pH/conductivity, osmolality/freezing point depression, viscometry, densitometry).
• Experience designing, characterizing, and implementing processes in a manufacturing or regulated environment, including scale-up or technical transfer.
• Strong problem-solving skills, with 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 an ability to work as an effective member of a team.
• High level of accuracy in documentation, record-keeping, and reporting.

The following skills and experience are preferred for the position:

• 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 (DOE, ANOVA, regression, capability analysis; JMP, Minitab, or similar).
• Working knowledge of quality systems (e.g., ISO 13485) including NCR, CAPA, and change control processes.
• Experience training or providing technical guidance to junior staff.

Education and 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.

Compensation

The base compensation for the Scientist I role starts at $80,000-$95,000 + 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 experience

Applications without a Letter of Motivation will not be considered. Local candidates preferred.

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 PLEASE

We 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 EMPLOYER

Watchmaker 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.