QC Principal Scientist - Microbiology (Cell Therapy)

Lonza•Portsmouth, NH

23h•Onsite

About The Position

As a QC Principal Scientist in the Microbiology department, you will serve as the Subject Matter Expert (SME) and technical anchor for Cell Therapy operations. This role involves strategic oversight of microbial control activities, including method transfers, validation projects, and complex trend analysis. It is a high-level individual contributor position, acting as a technical advisor to site leadership and a mentor to junior staff, ensuring personalized therapies meet global regulatory standards through scientific excellence. You will serve as a primary SME for Microbiology, influencing site-wide quality strategy and representing the department in cross-functional leadership teams. The position also entails leading high-visibility investigations and continuous improvement projects that directly impact the efficiency and compliance of the Cell Therapy asset, and playing a key role in regulatory inspections, acting as a primary technical witness and SME in both front and back-room settings.

Requirements

Bachelor’s degree in Microbiology, Biochemistry, or a related Science discipline.
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 microbiology 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.
Ability to 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)

Responsibilities

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 during audits.
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.
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.
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.
Act as a technical advisor to site leadership and a mentor to junior staff.