QC Principal Scientist - Microbiology (Cell Therapy)

Lonza•Portsmouth, NH

1d•Onsite

About The Position

As a QC Principal Scientist in our Microbiology department, you serve as the Subject Matter Expert (SME) and technical anchor for our Cell Therapy operations. You are responsible for the strategic oversight of microbial control activities, including method transfers, validation projects, and complex trend analysis. This is a high-level individual contributor role that acts as a technical advisor to site leadership and a mentor to junior staff, ensuring our personalized therapies meet global regulatory standards through scientific excellence.

Requirements

Bachelor’s degree in Microbiology, Biochemistry, or a related Science discipline is required.
5–10+ years of relevant experience in a professional GMP environment.
Proven track record of managing complex QC projects and leading technical investigations.
Extensive knowledge across multiple disciplines, including Sterility Testing, Endotoxin analysis, and Microbial ID/Genomics.
Expert knowledge of cGMP principles and global pharmacopeia (USP, EP, JP).
Advanced experience with Quality Systems such as TrackWise and LIMS.
Ability to mentor junior staff and resolve technical problems with little to no day-to-day instruction.
Strong ability to organize technical information into logical, coherent reports and present with confidence to site leadership and regulatory auditors.
A champion for change who drives successful implementation of new initiatives.

Nice To Haves

An Advanced Graduate Degree (Master’s or PhD) is highly preferred.

Responsibilities

Serve as a primary SME for Microbiology, influencing site-wide quality strategy and representing the department in cross-functional leadership teams.
Lead high-visibility investigations and continuous improvement projects that directly impact the efficiency and compliance of the Cell Therapy asset.
Play a key role in regulatory inspections, acting as a primary technical witness and SME in both front and back-room settings.
Lead the authoring and execution of protocols for method transfers, qualifications, and validations.
Identify technical risks and implement mitigation strategies to ensure on-time program completion.
Provide expert guidance to internal operations and contracted suppliers across a broad spectrum of microbiology disciplines.
Act as the technical resource for cross-functional teams involving Manufacturing and Quality Assurance.
Actively participate in internal and external audits (FDA, EMA, etc.).
Defend technical data, explain complex microbial processes, and support the "back-room" strategy team.
Perform and lead high-complexity deviation and investigation activities.
Apply root cause analysis (RCA) to identify systemic issues and implement effective CAPAs.
Perform high-level review of laboratory records and author/approve QC SOPs, protocols, and specifications to ensure 100% adherence to cGMP and global regulatory guidelines (USP, EP, JP).
Troubleshoot assay and instrumentation issues through advanced data mining and trend analysis to support long-term laboratory operational health.