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Documentation Specialist, Work Instructions, Specifications, and Labeling

CDI
Daly City
Salaire : Non spécifié
Télétravail non autorisé
Expérience : > 5 ans

DNA Script
DNA Script

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Le poste

Descriptif du poste

DNA Script

DNA Script is a leading company in manufacturing de novo synthetic nucleic acids using enzymatic DNA synthesis (EDS) technology. The company aims at accelerating innovation in life science and technology through the decentralization of rapid, on demand and high-quality DNA synthesis. DNA Script's approach leverages nature's billions of years of evolution in synthesizing DNA to set a new standard for customizing nucleic acid synthesis thus accelerating discovery in genetics, genomics, and synthetic biology. Discovery disciplines with profound impacts upon humanity such as biopharma, translational genetics and even molecular information storage all start with synthetic DNA. The company has recently initiated the commercialization of its first EDS powered platform, the SYNTAX system.

To date, DNA Script has raised over $315M of financing, with leading investors such as Coatue Management, Fidelity Management and Research, Catalio Capital Management, Casdin Capital, LSP, Bpifrance Large Ventures, Danaher, Illumina Ventures, Agilent, Merck Ventures, Sofinnova Partners, Kurma Partners, T Rowe Price, Baillie Gifford and Eurazeo.

DNA Script also partners on technology and product development with leading organizations such as DARPA, IARPA, Moderna Therapeutics, GE Research, Illumina, the Broad Institute, Harvard University, Institut Pasteur and the French Department of Defense.

DNA Script has its research and manufacturing facilities headquartered in Paris, France, and is in the process of expanding its commercial and development teams in South San Francisco.

Opportunity and Challenges :

We are looking to assemble a team of best-in-class, innovative and passionately eager people. We want to gather their talents and skills to achieve one goal: unlock the power of “DNA-write.” We offer the opportunity of joining a dynamic, international, and highly skilled team in a pioneering startup. Our DNA On Demand platform not only has the potential to change the way the world makes and uses synthetic DNA, but also to accelerate the rate of discovery by delivering upon the promise of same-day results.

This is an opportunity to join a rapidly growing company and to have a large impact on developing a technology that will have far-reaching impacts across biological sciences.

The Role

DNA Script is actively searching for a Documentation Specialist / Technical Writer to author, review and release documentation supporting the Product Development team. This person will work cross-functionally with R&D, Product Development, Marketing, Operations, and Support Engineering as needed to ensure timely completion of documentation in accordance with project plans and timelines. This is an opportunity to join a rapidly growing company and to have a large impact on developing a technology that will have far-reaching impact across biological sciences.

Responsibilities

  • Author, edit and release documentation produced within a GMP environment required for the production of DNA Script products including but not limited to:
    • Raw material and finished product specifications
    • Label design specifications
    • Forms and document templates
    • Incoming, in-process, and final acceptance test methods
    • Standard operating procedures
    • Manufacturing work instructions and batch records
  • Coordinate with Product Development and Program Management to identify and prioritize closure of gaps in specifications, labeling, work instructions and test methods.
  • Trace specifications to product requirements and identify gaps/optimize requirement documentation.
  • Prepare change order documentation and work with stakeholders to align on and approve documents.
  • Analyze upstream and downstream processes and make recommendations regarding effective documentation
  • Work on technical writing assignments that are complex in nature where action and a high degree of initiative are required to resolve challenges associated with new processes
  • Track documentation project deliverables and manage to timelines
  • Provide training related to documents generated, as needed
  • Assist in documentation audits as necessary

Ideal Candidate will have

  • Demonstrated technical writing skills with the ability to create clear and concise written instructions and intuitive recording forms.
  • Knowledge of biological sciences, DNA applications and technology generally obtained through Associated or 4-year degree in life science related discipline.
  • Foundational knowledge and experience in reagent formulation and manufacturing in biotechnology industry
  • Working knowledge of GMP and GDP
  • Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected
  • Strong proficiency with computer systems, including JIRA, eQMS system, OneDrive, and MS Office suite, particularly Word, Excel, and PowerPoint.
  • Strong organization skills, with the ability to organize, plan, prioritize work, and manage multiple projects effectively, within agreed upon timelines.
  • Strong interpersonal skills, with the ability to positively interface with individuals at all levels of the organization.
  • Strong communication skills, including written, verbal, and presentation.
  • Strong team orientation, with the ability to self-start, as well as work independently.
  • Strong attention to detail with the ability to perform tasks with a high degree of accuracy.
  • A minimum of 5+ years process operations experience in a manufacturing facility subject to GMP regulations with at least one year experience with technical writing
  • The ability to represent the Company in front of customers, collaborators, industry peers and scientists
  • The highest level of personal honesty, integrity and commitment; unquestionably walks the talk so others want to follow

Miscellaneous

  • Start date: Q1 2022

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