Candidate can sit anywhere in US. Please list location at the top of the resume
Standout experience would be working in a contract testing or contract manufacturing lab and project management experience. Past experience in a scientific/pharmaceutical lab in addition to project management experience.
Responsibilities
Work with external contract development and manufacturing organizations to support delivery of large molecule analytical work packages (method qualification, method transfer, release testing, stability testing, characterization).
Monitor deliverables for release and stability testing at external contract testing labs.
Track key project milestones and adjust project plans and/or resources as needed.
Coordinate domestic and international shipments for temperature sensitive materials.
Recognize functional, quality, and timeline issues and escalate when necessary.
Self-starter who can orchestrate multiple assignments and prioritize accordingly.
Advance reviews, decisions, and approvals within matrixed teams to keep timelines on track.
Coordinate with cross-functional stakeholders within Operations to ensure external analytical work packages are delivered on time, within budget, and adhere to quality standards.
Preferred Qualifications
B.S. Degree In Biologic science or related field.
Project management experience.
Experience in large molecule analytical development including method development, method qualifications/transfers/validations, release, stability and characterization testing.
Experience collaborating with Contract Manufacturing or Contract Analytical Laboratories.
Strong understanding of cGMP, Regulatory/CMC, legal, Quality requirements and import/export policies.
Experience as team member of cross-functional and matrixed teams including effective writing, presentation, organizational and interpersonal skills to address a broad scope of audiences.
Top 3 Must Have Skill Sets:
Management of Scientific Contract Testing Labs or Pharmaceutical Contract Manufacturing Organizations
Release & Stability Testing for Pharmaceutical Development
Project Management
Pay Rate between $46 - $52/Hr on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"