Fujifilm Manufacturing USA, Inc

Analytical Project Leader, Quality Control

Fujifilm Manufacturing USA, Inc • $90K — $120K *
College Station, TX 77840In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • PhD with 3+ years, or a Master's with 6+ years, or Bachelor's with 8+ years in Analytical Chemistry, Biochemistry, or related field.
  • Minimum two years of program coordination experience required.
  • Strong technical knowledge across multiple analytical platforms, with a focus on mAb or VGT.
  • Fluent in CMC regulatory processes; PMP training preferred but not mandatory.
  • Demonstrated ability in sponsor management and client-facing communication.
  • Detail-oriented with excellent writing skills and a positive client engagement style.

Responsibilities

  • Serve as the single technical voice for 5-7 active programs.
  • Own and implement the analytical strategy for assigned programs.
  • Manage risk against the analytical target product profile (ATP) for programs.
  • Sign off on validation protocols and acceptance criteria.
  • Coordinate and manage validation and tech transfer activities with method leads.
  • Lead standing meetings with sponsors under batched governance.
  • Contribute to the analytical sections of CMC narratives for client submissions.

Benefits

  • Opportunities for professional development and advancement.
  • Collaborative work environment with cross-functional teams.
  • Flexibility in work arrangements to accommodate personal needs.
  • Comprehensive health and wellness benefits.
Full Job Description
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 4Red4 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,
  • Master9s degree and six (6) years of relevant experience; OR,
  • Bachelor9s 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.


About Fujifilm Manufacturing USA, Inc

Fujifilm Manufacturing USA, Inc is a subsidiary of Fujifilm Holdings Corporation, a Japanese multinational conglomerate that specializes in imaging and photography. Fujifilm Manufacturing USA, Inc is responsible for the manufacturing of photographic paper, film, and other imaging products in the United States. The company was established in 1988 and has its headquarters in Valhalla, New York. Fujifilm Manufacturing USA, Inc operates as a subsidiary of Fujifilm North America Corporation.
Learn more about Fujifilm Manufacturing USA, Inc
Size
72,332 employees
Industry
Manufacturing & Automotive
NASDAQ
FUJIF
* Ladders Estimates

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