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

Medical Edge Recruitment

College Station, TX

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JOB DETAILS
SALARY
$75
SKILLS
Analysis Skills, Analytical Chemistry, Analytical Development, Analytical Method Development, Analytical Method Validation, Antibodies, Biochemistry, Biology, Biotech and Pharmaceutical, Communication Skills, Consulting, Cross-Functional, Customer Relations, Documentation, Employment Law, Gene Therapy, Investigational New Drug (IND), Leadership, Manufacturing Requirements, Presentation/Verbal Skills, Project Management Certification, Project Management Professional (PMP), Project/Program Coordination, Quality Control, Regulatory Submissions, Relationship Management, Risk, State Laws and Regulations, Technical Leadership, Technical Presentation
LOCATION
College Station, TX
POSTED
19 days ago

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

About the Company

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Medical Edge Recruitment

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