Engineering Associate Director

Planet Group

North Carolina

Target PR Range: 70-80/hr
*Depending on experience

Highly versatile and experience subject matter expert able to contribute as an individual or to lead teams across a wide range of drug substance technical areas. Responsible for aspects of the successful preparation, strategy, and execution of Technology Transfer, Process Scale-up, Clinical & Commercial Manufacturing Support, Process Performance Qualification (PPQ) during the start-up a of new Drug Substance production facility. Responsible for also being able to enable CMC Regulatory file drafting and support, commissioning and qualification of equipment, utilization of process models, process characterization, and process optimizations and troubleshooting. The qualified candidate will lead technical teams across various disciplines and objectives.

Some examples of Additional Responsibilities: Work cross-functionally with individuals and project teams in Process Development, Manufacturing, Quality, and Facilities and Engineering; Create and assess process technical assessments to support deviations and validations; create and execute to project plans and schedules; develop, execute, and review technical documents, validation documents, specifications, development plans, characterization plans, and verification and validation plans; provide deep technical assistance for junior engineers.

Basic Qualifications:
Doctorate degree and 3 years of experience
OR
Master’s degree and 7 years of experience
OR
Bachelor’s degree and 9 years of experience
OR
Associate’s degree and 12 years of experience
OR
High school diploma / GED and 14 years of experience

*CO/NYC candidates might not be considered

Posted 2025-09-29

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