Sr. Deviation Investigator

United States, Portsmouth (New Hampshire)

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. Lonza Pharma & Biotech has an opening for a Senior Principal Investigator at their Portsmouth, NH Location.

The Sr. Deviation Investigator is responsible for the investigation of process deviations aimed at identification of root cause and implementation of correct actions to prevent recurrence and is seen as an investigational technical expert.  A Senior Investigator Level II is expected to work in a cGMP environment, have an expert level working knowledge of mammalian manufacturing processes, the ability to manage multiple ongoing projects concurrently as well as mentor and train others within the group, have excellent meeting facilitation and conflict resolution skills, a professional and expert technical writing capability, be action oriented, and be compliant minded while performing investigations. 

The Principal Investigator serves as the primary technical interface with the client and internal multi-disciplinary technical teams to define strategy for formulation, process, and product development and interface as the CMC lead for clients. They will oversee multiple cross functional product development teams for client programs to execute work plans against specific hypothesis and problem statements.  They will review, interpret, and react to data to make tactical and strategic decisions in order to maintain or change product development plans for the portfolio and/or technology. 

Key Responsibilities:

  • Lead the design of tools, systems, or trainings which will improve the investigations requirements definition, matching investigation priorities to industry best practices and balance site needs to positively impact quality and delivery at the site.
  • Coach and Mentor as well as share knowledge in order to significantly enhance performance within the organization with the long term view of constructing sustainable, high performing investigation teams.
  • Provide direction on deviation approach for the investigators and associated investigation teams, and as this occurs, transfer knowledge to the personnel involved to elevate expertise of the teams.
  • Work to achieve >80% Right First Time on customer deviation reviews.
  • Drive for effective CAPA such that deviations do not recur.
  • Perform investigations for complex events.
  • Set up certification for investigators such the level of expertise is confirmed quantitatively to meet expectations.

Key Requirements:

  • Seasoned professional in pharmaceutical or related field
  • Bachelors degree or higher in Biotechnology, Biology or chemistry (or similar field)
  • Experience with tech transfer, regulatory, and GMP operations
  • Experience working with oral drug products (Tablets, capsules, multi-particulates) and/or orally inhaled drug products
  • Experience with oral bio-availability enhancement formulation approaches and unit operations

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: R34670