Senior CMC Project Leader (Analytical)

FUJIFILM Biotechnologies; College Station (TX); On-site; USD 130,000 - 180,000; Full time

Job summary

FUJIFILM Biotechnologies Texas seeks a highly experienced scientist to lead analytical strategy across multiple programs. You will own method selection, validation plans, and regulatory coordination with clients, ensuring risk is managed within defined thresholds.

Ideal candidates hold a PhD with years in GMP environments, strong writing and communication skills, and a track record in sponsor management and cross‑functional collaboration. This on‑site role is based in College Station, TX.

Qualifications

• PhD with 3+ years of relevant experience; or Masters 6+ years; or Bachelor’s 8+ years in analytical roles.
• Degree in Analytical Chemistry, Biochemistry or related field.
• Two or more years in program coordination.

Responsibilities

• Serve as single technical voice to sponsor for 5–7 active programs.
• Own program-level analytical strategy: method selection, validation strategy, transfer plan.
• Accept risk against ATP for assigned programs within 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).
• Coordinate with Validation/Tech Transfer leads on validation/transfer activities.
• Run sponsor-level standing meetings under batched governance.

Skills

Senior Scientist breadth

Analytical platform breadth

CMC regulatory fluency

Sponsor management

PMP-lite project management

Client-facing communication

Attention to detail & writing

Education

PhD in Analytical Chemistry/Biochemistry or related

MS in relevant field

BS in relevant field

Job description

FUJIFILM Biotechnologies Texas seeks a highly experienced scientist to lead analytical strategy across multiple programs. You will own method selection, validation plans, and regulatory coordination with clients, ensuring risk is managed within defined thresholds.

Ideal candidates hold a PhD with years in GMP environments, strong writing and communication skills, and a track record in sponsor management and cross‑functional collaboration. This on‑site role is based in College Station, TX.