Asks for

The ad says“ISO 9001 and/or ISO 13485 standards or operating within a structured quality management system (QMS).”
The ad says“ISO 9001 and/or ISO 13485 standards or operating within a structured quality management system (QMS).”
The ad says“General statistical techniques such as regression analysis and significance testing (e.g., Analysis of Variance (ANOVA), t-tests).”
The ad says“Principles of recombinant protein expression and protein purification, including chromatography.”
The ad says“Designing and monitoring processes using statistical methods such as Design of Experiments (DOE) and Statistical Process Control (SPC).”
The ad says“Basic protein biochemistry (e.g., physical properties, experimental methods, enzyme kinetics, etc.)”
The ad says“Risk management and hazard analysis frameworks or tools, such as Failure Modes and Effects Analysis (FMEA).”
The ad says“Assessing analytical measurement methods and process capabilities, using statistical techniques such as Measurement Systems Analysis (MSA) or Gauge Repeatability & Reproducibility (Gauge R&R).”
The ad says“Assessing analytical measurement methods and process capabilities, using statistical techniques such as Measurement Systems Analysis (MSA) or Gauge Repeatability & Reproducibility (Gauge R&R).”
The ad says“PCR and next-generation sequencing (NGS) techniques.”
The ad says“PCR and next-generation sequencing (NGS) techniques.”
The ad says“Basic protein biochemistry (e.g., physical properties, experimental methods, enzyme kinetics, etc.)”
The ad says“Principles of recombinant protein expression and protein purification, including chromatography.”
The ad says“ISO 9001 and/or ISO 13485 standards or operating within a structured quality management system (QMS).”
The ad says“Principles of recombinant protein expression and protein purification, including chromatography.”
The ad says“General statistical techniques such as regression analysis and significance testing (e.g., Analysis of Variance (ANOVA), t-tests).”
The ad says“Designing and monitoring processes using statistical methods such as Design of Experiments (DOE) and Statistical Process Control (SPC).”
The ad says“General statistical techniques such as regression analysis and significance testing (e.g., Analysis of Variance (ANOVA), t-tests).”

Position: Senior Process Development Associate

Focus Area: Enzyme Manufacturing

Department: Process Development

Position Type: Full-Time Employee

Location: Boulder, CO, onsite

Experience: Bachelor’s degree (ideally in Biochemistry or Biochemical Engineering) + min of 5 years relevant experience in process development or bioprocess manufacturing; or Masters and 3 years.

Position Summary

We are seeking a Senior Process Development Associate to join our Process Development team in Boulder, CO.

As part of the Process Development team, you will apply your expertise in process engineering to design and transfer recombinant protein expression and purification processes, reporting to one of our Senior Scientists. You will contribute directly in delivering high-quality, innovative products to our customers. In this highly collaborative role, you will work closely with various departments, including R&D, Production, IT, and Quality Assurance across our global sit

Responsibilities

The Process Development team supports the transfer of new products from R&D to manufacturing. This involves translating product requirements into process specifications and developing efficient, scalable processes to meet these needs. After product launch, the team provides ongoing support for process updates to maintain product quality.

Specific responsibilities include:

Building and optimizing recombinant protein expression and purification processes for use in routine manufacturing.
Contributing to robust, rigorous experimental design and execution for the development and testing of new processes and comprehensively documenting outcomes.
Identifying and documenting process risks, assessing potential impacts, and developing appropriate mitigations.
Identifying critical process parameters (CPPs) to ensure critical-to-quality attributes (CQAs) are consistently achieved.
Developing or adapting processes to meet CPPs by investigating new methods, equipment, and controls and confirming suitability through experimentation.
Identifying opportunities for process streamlining, standardization, and alignment with industry best practices.
Planning and executing assigned project deliverables and proactively communicating status and outcomes.
Contributing to process, equipment, and computer systems validation, as well as material qualification, by establishing clear, testable specifications based on CPPs and CQAs, along with associated experimental planning.
Having a working understanding of the ISO 13485 standard and internal standard operating procedures (SOPs) to effectively apply these principles.
Supporting on-market products by investigating process-related issues through data trending, analysis, or experimentation.
Authoring and revising work instructions, batch record templates, and other production-facing documentation that are clear and concise to ensure reproducible results.
Preparing training materials and conducting classroom and on-the-job training for operators on new or revised procedures.

Skills and Requirements

Specific skills and requirements include:

Principles of recombinant protein expression and protein purification, including chromatography.
Basic protein biochemistry (e.g., physical properties, experimental methods, enzyme kinetics, etc.)
Predisposition for systems-level thinking, as applied to designing and implementing robust, scalable processes for enzyme manufacturing.
Demonstrated scientific excellence in technical work, written communication, and presenting technical information to groups with various scientific backgrounds.
Adaptability, curiosity, and the ability to grasp and apply new concepts quickly.
Critical thinking and problem-solving skills.
Commitment to a culture of excellence and advocacy for continuous improvement.
Strong interpersonal skills with the ability to effectively communicate across multi-level, cross-functional teams.
Excellent organizational skills and attention to detail.
Strong personal task management skills and a high level of self-motivation.
Excellent written and verbal communication skills.

Technical understanding of and/or experience with:

PCR and next-generation sequencing (NGS) techniques.
Risk management and hazard analysis frameworks or tools, such as Failure Modes and Effects Analysis (FMEA).
Assessing analytical measurement methods and process capabilities, using statistical techniques such as Measurement Systems Analysis (MSA) or Gauge Repeatability & Reproducibility (Gauge R&R).
Designing and monitoring processes using statistical methods such as Design of Experiments (DOE) and Statistical Process Control (SPC).
General statistical techniques such as regression analysis and significance testing (e.g., Analysis of Variance (ANOVA), t-tests).
ISO 9001 and/or ISO 13485 standards or operating within a structured quality management system (QMS).

Education and Experience

Bachelor’s degree (ideally in Biochemistry or Biochemical Engineering) + min of 5 years relevant experience in process development or bioprocess manufacturing; or Masters and 3 years

Compensation

The base compensation for the Sr PD Associate Enzyme role starts at $75,000-85,000 + 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.