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
Numbers & Facts
| Location | College Station, TX |
| Salary | $75 |
Skills
Analysis Skillsunmatched
Analytical Chemistryunmatched
Analytical Developmentunmatched
Analytical Method Developmentunmatched
Analytical Method Validationunmatched
Antibodiesunmatched
Biochemistryunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Communication Skillsunmatched
Consultingunmatched
Cross-Functionalunmatched
Customer Relationsunmatched
Documentationunmatched
Employment Lawunmatched
Gene Therapyunmatched
Investigational New Drug (IND)unmatched
Leadershipunmatched
Manufacturing Requirementsunmatched
Presentation/Verbal Skillsunmatched
Project Management Certificationunmatched
Project Management Professional (PMP)unmatched
Project/Program Coordinationunmatched
Quality Controlunmatched
Regulatory Submissionsunmatched
Relationship Managementunmatched
Riskunmatched
State Laws and Regulationsunmatched
Technical Leadershipunmatched
Technical Presentationunmatched
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