Engineer Associate Director – Start-Lead New Drug Substance Facility (JP14556)

3 Key Consulting•Holly Springs, NC

15d•Remote

About The Position

3 Key Consulting is hiring an Engineer Associate Director for a consulting engagement with our direct client, a leading global biopharmaceutical company. Candidates will be thoroughly screened for their experience and basic qualifications. We are NOT looking for an SME in a specific area but instead an independent experienced leader who can come into a new and upcoming site with a broad spectrum of knowledge and experience to be utilized amongst site teams. Highly versatile and experienced 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 enabling 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.

Requirements

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.
Independent experienced leader with a broad spectrum of knowledge and experience.
Highly versatile and experienced subject matter expert able to contribute as an individual or to lead teams across a wide range of drug substance technical areas.
Experience in Technology Transfer.
Experience in Process Scale-up.
Experience in Clinical & Commercial Manufacturing Support.
Experience in Process Performance Qualification (PPQ).
Experience in CMC Regulatory file drafting and support.
Experience in commissioning and qualification of equipment.
Experience in utilization of process models.
Experience in process characterization, and process optimizations and troubleshooting.
Strong technical and management skills.
Ability to deliver as an individual and team lead.
Strong collaborations skills.
Track record of team environment success.

Nice To Haves

Principal Engineer or Director level in their current role.

Responsibilities

Lead or contribute teams in areas of Technology Transfer, Process Scale-up, Clinical & Commercial Manufacturing Support, Process Performance Qualification (PPQ), CMC Regulatory file drafting and support, commissioning and qualification of equipment, utilization of process models, process characterization, and process optimizations and troubleshooting, delivering the required business result.
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.