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Description

Watchmaker Genomics is an early-stage life science company based in Boulder, Colorado. Our team is passionate about innovation and values collaboration, creativity and scientific rigor. We believe 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 Specialist, Technical Writer.

The successful candidate will thrive in a dynamic, fast-paced working environment and contribute directly to our company culture and success. The position provides an opportunity to develop as a process development technical writer at the intersection of Operations, Quality Assurance (QA), and Research & Development (R&D). This role will focus on devising, optimizing, implementing and monitoring the effectiveness of written processes within the organization.

Responsibilities

  • Collaborate with QA, Operations (including production, accounting and facilities), R&D, Product Management and Business Development to improve the quality, efficiency and scalability of high level processes
  • Author, review and publish Standard Operating Procedures (SOPs) for the manufacture of genomics products
  • Create and maintain technical documents related to the process development and optimization of products for genomic applications, such as batch records, change controls, and protocols
  • Create training content, train process users, and build scalable training programs
  • Independently, or as part of a team, contrive, support and drive continuous improvement projects to completion
  • Participate in, provide guidance and lead in non-conformance investigations, root cause analyses, risk assessments and corrective and preventive action plans
  • Support and strive to improve the quality and efficiency of various process systems, such as:
    • New Product Development (NPD)
    • Validation and verification
    • Product stability
    • Design transfers including ERP and MES part creation
    • Post market product care
  • Ensure compliance with all relevant regulatory requirements, including ISO-13485 guidelines
  • Other duties as assigned

Skills and Requirements

Experience in quality assurance, biotechnology and a start-up environment are highly desirable. The following skills and experience are requirements for the position:

  • Computer proficiency and ability to use complex electronic QMS and/or business systems including process mapping software and Microsoft and/or Google Suite software (word/docs, excel/sheets, etc.)
  • A strong passion for and demonstrated excellence in technical writing
  • Knowledge and an understanding of production processes and manufacturing technologies
  • A basic understanding of various laboratory techniques used in enzymology and/or molecular biology such as, but not limited to, protein purification, PCR and next generation sequencing (NGS)
  • Experience using various quality tools/mechanisms such as nonconformance investigations, root cause analysis, corrective and preventive action (CAPA), change control, process validation and design verification, and risk management tools like failure mode and effect analysis (FMEA)
  • Proven knowledge of ISO13485 standards and how to operate within a structured quality management system (QMS)
  • Excellent organizational skills and attention to detail
  • The ability to multitask, be able to work at a high standard, perform consistently under pressure along with pre-determined deadlines and work without supervision
  • Strong interpersonal skills and an ability to work as an effective member of a team
  • Good communication and personal task management skills and a high level of self-motivation and initiative
  • A creative and disciplined approach to problem-solving

The following skills and experience are preferred for the position:

  • Familiarity with various business systems/softwares such as Inventory Management and Enterprise Resource Management (ERP), Quality Management Systems (QMS), and Manufacturing Execution Systems (MES)
  • Six sigma, 5S, ASQ, Kaizen or other training/certifications relevant to process improvement
  • Experience in product development and presenting information to groups with various backgrounds
  • Experience in statistical analysis techniques such as Design of Experiments (DOE), Analysis of Variation (ANOVA), measurements of central tendency, etc.

Education and Experience

  • PhD in life science or engineering and 0-3+ yrs industry experience, or:
  • MS/MA and 3-6+ yrs industry experience, or:
  • BS/BA and 5-8+ yrs industry experience

Compensation

The base compensation for the Process Development Specialist – Technical Writer role starts at $70,000 – $85,000 + bonus + equity; actual pay will be adjusted based on skills and experience. Employees are eligible for Flexible Time Off, Holidays, Medical, Dental, Vision, Life/AD&D, Short Term Disability, EAP, and a 401(k) retirement plan.

Application Procedure

To apply for the position, please submit the following in a PDF format on watchmakergenomics.com:

  • Letter of motivation
  • Resume or Curriculum vitae, highlighting relevant qualifications and experience

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

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.

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.