Associate Project Manager
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Job Title: Associate Project Manager
Location: Thousand Oaks, CA (Remote)
Duration: 12 Months contract on W2
Schedule: Business hours
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.