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Analytical Project Leader (APL) - Contract - 6 Months - Large biotech

Job

Medical Edge Recruitment

College Station, TX (In Person)

$182,000 Salary, Full-Time

Posted 1 week ago (Updated 3 days ago) • Actively hiring

Expires 7/23/2026

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Job Description

Analytical Project Leader (APL)
  • Contract
  • 6 Months
  • Large biotech Medical Edge Recruitment
  • 3.8 College Station, TX Job Details Contract $75
  • $100 an hour 1 day ago Qualifications FDA submissions Customer communication Project development phase management Investigational new drug (IND) applications Technology transfer (scale-up process) Pharmaceutical analysis Materials analysis (analytical chemistry specialty) Client management Chemistry, manufacturing & controls Collaboration with manufacturing teams Regulatory submission editing and review Communication with regulatory authorities for clinical trials Verification of laboratory test methods Test validation method Project risk management Cross-functional communication Full Job Description Medical Edge Recruitment has an immediate opening for an "Analytical Project Leader (APL)" for a position in the "Greater Houston, TX Area"
Details:
Specialty:
Analytical Development / CMC /
Biopharmaceutical Development Location:
Greater Houston, TX Facility Type:
Biopharmaceutical / CDMO /
Life Sciences Organization Pay Rate:
$75
  • $100 per hour + Per Diem for
Travel Shift/Hours:
Full-Time, Contract/Consulting Opportunity, 6 months estimated duration + potential extensions
Requirements:
MS or PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline
APL:
5-8 years of biopharmaceutical analytical development experience with at least 2 years of program coordination experience
Senior APL:
10+ years of biopharmaceutical analytical development experience with at least 5 years of client-facing program leadership experience Experience serving as the technical lead and primary client contact for analytical programs Strong understanding of analytical method development, validation, qualification, and transfer Experience supporting CMC regulatory submissions including IND and/or BLA documentation Ability to develop and execute analytical strategies across multiple programs simultaneously Experience managing sponsor relationships and presenting technical data to clients Knowledge of analytical testing platforms supporting biologics, monoclonal antibodies (mAbs), and/or viral gene therapy (VGT) products Strong understanding of stage-gate development processes and risk-based decision making Experience working cross-functionally with Analytical Development, QC, Validation, Tech Transfer, Manufacturing, and Regulatory teams PMP certification or formal project management training preferred Excellent communication, leadership, and client-facing presentation skills
FOR THIS TYPE OF EMPLOYMENT STATE LAW REQUIRES A CRIMINAL RECORD CHECK AS A CONDITION OF EMPLOYMENT
#indeed