Environmental Monitoring and Sterility Assurance Principal, Quality Control

United States, Lexington (Massachusetts)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The Environmental Monitoring and Sterility Assurance Principal will be responsible for all aspects of Environmental Monitoring for the drug substance and drug product manufacturing suites.

The Environmental Monitoring and Sterility Assurance Principal will develop a strategic plan and expertise for development and implementation of the site microbial contamination strategy. This individual will be the site Lead for all required Environmental Monitoring responsibilities and activities.

Must have strong leadership abilities, communication and interpersonal skills. Responsible for meeting deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously. Capable of strategic thinking and  proposing innovative solutions. Must be capable of collaborating in a team environment. Should be able to influence through effective communication and be flexible and responsive to changes in priorities and planning.

S/he will provide guidance, oversight and support to all departments at the Lexington site to ensure that Sterility Assurance and aseptic controls meet the requirements of site and global documents, and regulatory standards. S/he will assist in building and maintaining strong working relationships with technical internal and external business partners. Formulates and meets quality control objectives. Sets priorities to ensure quality and timelines are met and samples are tested, reviewed and reported within the accepted time frames. Interprets data and resolves technical issues.

Key responsibilities:

  • Design and manage method suitability and environmental monitoring for routine testing.
  • Generation of monthly, quarterly, and annual Environmental Monitoring reports and data trending.
  • Leads QC investigations for Environmental Monitoring OOS, deviations and investigations and provides investigation closure.
  • Leads and participates in providing the necessary information for client regulatory filings and inspections.
  • Leads and supports CAPA/Continuous Improvement Initiatives.
  • Supports sterility/microbial specification development for incoming raw materials and components.
  • Collaborates with internal and external business partners, including other CGT business units or departments and external suppliers, in support of continuous improvement initiatives.
  • Resolves technical problems through scientific understanding, options assessment, and application of innovative solutions.
  • Supports compliance of site manufacturing programs, processes, and facility systems.
  • Generates complete, accurate, and concise cGMP documentation.
  • Adheres to industry regulations and guidance documents when assisting in the creation and implementation of standards, policies, and site procedures

Key requirements:

  • B.S degree in Biochemistry, cell biology or similar Science field of study
  • Master of Science degree in biochemistry, cell biology or similar Science field of study preferred
  • Proficient in Sterility Assurance and Environmental Monitoring environment
  • Experienced knowledge in cGMP, ICH, EU and FDA regulations
  • Strong analytical, communication, presentation, and writing skills
  • Able to review and interpret data
  • Perform assigned, complex and/or varied tasks
  • Ability to plan, organize, and manage multiple projects simultaneously
  • Ability to develop and implement EM program for site activities
  • Ability to work cross-functionally in a fast-paced team environment as well as maintain successful relationships with external vendors
  • Proven track record of being personable, energetic, responsive, empowering, inclusive, action-oriented, accountable, and an effective communicator

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. 

Reference: R50556