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.

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.

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).
• Coordinate with Validation/Tech Transfer Leads (Method Owners) on validation/transfer activities.
• Run sponsor-level standing meetings under batched governance.

Requirements

• 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.

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

Qualifications

Minimum Qualifications: 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. Degree in Analytical Chemistry, Biochemistry or related field. A minimum of two (2) or more years in program coordination.

Preferred Qualifications: Experience working in or interfacing with a regulated GMP environment is desirable. Experience working in a contract manufacturing or testing organization is preferred.

Working Conditions & Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Experience prolonged standing, some bending, stooping, and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Ability to sit for long periods to work on a computer.
• Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
• Ability to wear personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required in most areas associated with this position.
• Lift up to 30 pounds on occasion.
• Attendance is mandatory.