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Software Test Manager

Company: Lykan Bioscience
Location: Hopkinton
Posted on: August 7, 2022

Job Description:

WHO WE ARELykan Bioscience is a fast-growing and innovative contract development and manufacturing organization (CDMO) focused on cell-based therapies. Cell therapy, one of the most transformative innovations in modern biotechnology, holds enormous potential for treating patients suffering from a variety of diseases. We are on a mission to improve patients' lives by innovating and delivering advanced cell-based therapies.OUR PASSIONWorking at Lykan is not just a job, it's an opportunity to work with a great team with diversified backgrounds and top-tier innovative biotechnology companies to contribute to the development and manufacture of revolutionary, life-saving treatments. Our team's passion for patients uniquely defines us. It's not about what we do; it's about why we do what we do. THE LYKAN WAYHere at Lykan, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Innovation, Excellence, Teamwork, Integrity, Trust, and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success, at Lykan we focus on developing our corporate culture, people's development, growth, and the ability to impact patients. ACCELERATING YOUR FUTURE The Software Test Manager is responsible for managing the team developing and executing test protocols ensuring compliance of Lykan's GxP computerized manufacturing systems with Lykan's Computer Systems Standards and in alignment with applicable GxP guidance and regulations, including GAMP5, 21 CFR Part 11 (US) and EU Annex 11. These activities include management of multiple projects that include testing of MES, Electronic Batch Record (EBR), LIMS, CMMS, and other computerized systems used in the manufacture of biological products.HOW YOU WILL MAKE AN IMPACT

  • Lead software testing projects to meet deliverables, technical, budget, and schedule goals including managing the work of internal and external resources, following up to ensure the desired result has been achieved.
  • Function as a site cross functional SME and technical expert for all questions and issues related to the MES, EBR, and software system testing supporting the manufacturing of cell therapy products.
  • Be a site leader in cGMP software testing technology and Lykan standards - develop technical expertise, conduct on-site training, etc.
  • Manage the testing of GxP software projects including test protocol development, test execution and compilation of test summary reports.
  • The Test Manager will provide software testing guidance to the site and will provide software testing education and awareness as needed.
  • Participate, as needed, in related audits of computerized systems, both internal and external.
  • Responsible for providing recommendations to improve and optimize the GxP testing strategy.Minimum Qualifications:
    • Bachelor's Degree in biological or computer science, or equivalent experience in a Pharma/Biologics environment
    • Minimum of 5+ years of pharmaceutical experience with specific experience applying 21 CFR Part 11 and EU Annex 11 requirements to testing scenarios.
    • Ability to prepare effective reports and present to management.
    • Ability to critically evaluate data summaries and conclusions.
    • Proficient in all MS Office applications (Excel, PowerPoint, etc.)Preferred Qualifications:
      • Evidence of teamwork, leadership and initiative taking is strongly desired.
      • An established record of successful project execution for GxP software testing, employing proven risk-based CSV principles and practice.OUR COMMITMENT All Lykanians embrace the principles of the Lykan Bio culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Lykan is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.

Keywords: Lykan Bioscience, Worcester , Software Test Manager, Executive , Hopkinton, Massachusetts

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