Process Validation Associate Principal Scientist at US02 Lonza Biologics Inc. in Portsmouth, New Hampshire

Job Description:

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 in Portsmouth, NH is growing, and we are seeking an experienced Process Validation Associate Principal Scientist.  Individual responsible for being a primary technical support person for MSAT PV.  This person has developed a core competency in supporting Process Validation Lifecycle activities (Stages 1-3) as defined by FDA and EMA.  The supervisor provides general direction and minimal oversight, as this level of Scientist is expected to have a good grasp of the requirements of the role.  The individual is a subject matter expert for all aspects of the role.

Key Responsibilities

• PV Best Practices and Global Point of Contact (POC): Works with global and other Lonza sites to incorporate best practices and align local procedures with GROUP procedures.  Recommends and drives improvements to PV practices and procedures via review of industry work groups technical documentation (ICH, FDA, EMA, PDA, ISPE, BPOG).


• Problem Solving: Represents PV on project teams and interfaces with customers on an ad hoc basis when complex technical issue(s) arise. Able to identify potential solutions and lead multidisciplinary teams in developing and implementing solutions.  Identifies process changes and assesses change controls for impact of process / equipment or procedural changes that can affect both process performance and product quality.


• General Support. Participates in customer and regulatory Audits. Supports documentation preparation for regulatory purposes. Performs global group document and global audit/quality gap assessments.     


• Training and Learning Modules: Implements and drives training / learning modules / process improvements across the team.


• Training: Follows all training and policy guidelines established for the facility as well as all cGMP requirements.  Ensures employee training profile is up to date at all times by regular monitoring of training lists (e.g., ComplianceWire, SAP Learning Portal) and completing all training in a timely fashion.


• Strong communication, technical writing, organizational and interpersonal skills; Strong computer skills (including Word, Excel, Outlook and PowerPoint.); Experienced in PV, QC, QA and MSAT mammalian cell culture processing; Demonstrates critical thinking skills in problem solving and decision making; Attention to detail and high level of accuracy; Has the confidence and credibility to influence discussions and resolve issues internally and externally; The capacity to motivate and encourage others, in the achievement of specific objectives, and to carry ultimate responsibility.

Key Requirements

Bachelor of Science degree Field of Study: Chemical Engineering, Mechanical, Biology, Biochemistry is preferred. 

12+ years of biotech industry experience (8+ years for Ph.D.). 

Experience with large scale manufacturing support (mammalian preferred), current Good Manufacturing Practices, US / EU regulations.

Experienced in PV, QC, QA and MSAT mammalian cell culture processing; Demonstrates critical thinking skills in problem solving and decision making; Attention to detail and high level of accuracy; Has the confidence and credibility to influence discussions and resolve issues internally and externally; The capacity to motivate and encourage others, in the achievement of specific objectives, and to carry ultimate responsibility.

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.