Quality Control Project Lead

Lonza; Pearland (TX); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance

Disability insurance

Employee assistance programs

Paid time off

Job summary

Lonza in Pearland, TX (on-site) seeks a QC Project Lead to drive the introduction of new methods and processes into the QC department through technology transfer. The role provides technical support for investigations, and acts as the QC representative on project teams involved in cell and gene therapy product testing.

The successful candidate will lead transfer plans, review regulatory guidance, and ensure CGMP compliance while writing and approving test records and QC documentation.

Qualifications

• Minimum 3–5 years of experience in Quality Control.
• Bachelor’s degree in a scientific discipline is required.
• Experience with method validation/qualification and technology transfer in a QC environment.
• Knowledge of biological and cell-based assays (flow cytometry, ELISA, HPLC, ddPCR, qPCR) preferred.

Responsibilities

• Lead tech transfer activities including development of transfer plans, protocols, and reports.
• Provide QC representation in project team meetings and communicate project status and timelines.
• Review regulatory guidance and internal policies to ensure compliance with cGMP standards.
• Write, review, and approve test records, sampling plans, specifications, and QC documentation.
• Support stability programs and track testing progress and deliverables.
• Collaborate with cross-functional teams including QA, MSAT, and manufacturing.
• Assist with deviations, OOS investigations, CAPAs, and audit responses.

Skills

Quality Control

Regulatory compliance

Project management

Cross-functional collaboration

Education

Bachelor's degree in a scientific discipline

Tools

Flow cytometry

ELISA

HPLC

ddPCR

qPCR

Job description

Location:This is an on-sitepositionlocatedin Pearland, TX.

Available shift: 8:00 am to 5:00 pm Monday through Friday

TheQuality Control (QC) Project Leadwilllead the introduction of new methods and processes into the Quality Control (QC) department through technology transfer, provide technical support for investigations, and act as the QC representative on project teams. This role supports method validation, ensures compliance with regulatory requirements, and contributes to the successful execution of QC testing for cell and gene therapy products.

What you will get:

• Performance-related bonus.
• Medical, dental and vision insurance.
• 401(k) matching plan.
• Life insurance, as well as short-term and long-term disability insurance.
• Employeeassistanceprograms.
• Paid time off (PTO).

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What you will do:

• Lead tech transfer activities including development of transfer plans, protocols, and reports.
• Provide QC representation in project team meetings and communicate project status and timelines.
• Review regulatory guidance and internal policies to ensure compliance with cGMP standards.
• Write, review, and approve test records,samplingplans, specifications, and QC documentation.
• Support stability programs and track testing progress and deliverables.
• Collaborate with cross-functional teams including QA, MSAT, and manufacturing.
• Assistwith deviations, OOS investigations, CAPAs, and audit responses.

What we are looking for:

• Experience from 3 to 5 years in Quality Control.
• Minimum ofBachelor’sdegreerequiredin a scientific discipline.
• Experience with method validation/qualification and technology transfer in a QC environment.
• Knowledge of biological and cell-based assays such as flow cytometry, ELISA, HPLC,ddPCR, and qPCRis preferred.
• Familiarity with cell and gene therapy products preferred.
• Strong understanding of cGMP principles and regulatory compliance.
• Demonstratedability to manage complex projects and prioritize tasks effectively.
• Strong communicationskills, including writing technical procedures and presenting project updates.
• Proven ability to collaborate, lead teams, and build cross-functional relationships.
• Proficient in using spreadsheets, databases, and word processing software.

About Lonza:

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence,Passionand Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, andthat’sthe kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. Ifyou’reready to help turn our customers’ breakthrough ideas intoviabletherapies, we look forward to welcoming you on board.

Reference: R80117

You will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.