Analytical Project Leader, Quality Control

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.

Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit:

Overview

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.

External US

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

Required Skills & Abilities:

• 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.

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. While performing the duties of this job, the employee is regularly required to:

• 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.

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.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (View email address on hirelifescience.com or View phone number on hirelifescience.com).