Analytical Project Leader, Quality Control

Fujifilm•College Station, TX

3d•Onsite

About The Position

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. 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.”

Requirements

Sr/Principal Scientist-level technical breadth.
Technical breadth across multiple analytical platforms (mAb or VGT focus).
CMC regulatory fluency.
Sponsor management.
PMP-lite project management.
Client-facing communication.
A keen eye for detail, excellent writing skills, and desire to engage in a positive manner with clients.
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.

Nice To Haves

PMP or equivalent project management training preferred.
Experience working in or interfacing with a regulated GMP environment is desirable.
Experience working in a contract manufacturing or testing organization is preferred.

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.