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Posted: 09/25/2024 Employment Type: Contract Job Category: Operations and Development Job Number: 4025

Job Description

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.

Basic Qualifications

Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience

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.

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