Analytical Project Leader, Quality Control

About the role

The Analytical Project Leader serves as the single technical voice to the sponsor for their assigned early-stage programs. Each APL typically manages active programs under sponsor-batched governance.

Responsibilities

• Serve as single technical voice to the sponsor for five (5) to seven (7) active programs on average.
• Own the program-level analytical strategy: method selection, validation strategy, transfer plan.
• Accept risk against the ATP for assigned programs (within pre-agreed thresholds).
• Sign off on validation protocol scope and acceptance criteria.
• Exercise authority to call a stage-gate "Red" and pause downstream work.
• Own analytical sections of CMC narrative shared with client (IND/BLA contributions).
• Cook up with Validation/Tech Transfer Leads (Method Owners) on validation/transfer activities.
• Run sponsor-level standing meetings under batched governance.

Requirements

• PhD and three (3) years of experience; OR, Master’s degree and six (6) years of relevant experience; OR, Bachelor’s and eight (8) years of relevant experience.
• Experience working in or interfacing with a regulated GMP environment is desirable.
• Experience working in a contract manufacturing or testing organization is preferred.

Qualifications

The optimal candidate will have a keen eye for detail, excellent writing skills, and desire to engage in a positive manner with clients.

Skills

• Sr/Principal Scientist-level technical breadth.
• Technical breadth across multiple analytical platforms (mAb or VGT focus).
• CMC regulatory fluency; PMP or equivalent project management training preferred.
• Sponsor management.
• PMP-lite project management.
• Client-facing communication.

Benefits

Nestled between major hubs, it’s a dynamic location that blends convenience with innovation.

Pay

Salary commensurate with experience.

Schedule

Flexible work environment.

Company Overview

The work we do at FUJIFILM Biotechnologies Texas has never been more important—and we are looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you’re ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we’re proud to cultivate a culture that will fuel your passion, energy, and drive—what we call Genki.

Job Description

Essential Functions:

• Serve as single technical voice to the sponsor for five (5) to seven (7) active programs on average.
• Own the program-level analytical strategy: method selection, validation strategy, transfer plan.
• Accept risk against the ATP for assigned programs (within pre-agreed thresholds).
• Sign off on validation protocol scope and acceptance criteria.
• Exercise authority to call a stage-gate "Red" and pause downstream work.
• Own analytical sections of CMC narrative shared with client (IND/BLA contributions).
• Cook up with Validation/Tech Transfer Leads (Method Owners) on validation/transfer activities.
• Run sponsor-level standing meetings under batched governance.