3 Key Consulting, Inc. · 3 months ago
Engineer Associate Director – Start-Lead New Drug Substance Facility (JP14556)
Holly Springs, NC
Full-time
Hybrid
Senior Level, Lead/Staff
$82/hr - $92/hr
3+ years exp3 Key Consulting is hiring an Engineer Associate Director for a consulting engagement with a leading global biopharmaceutical company. The role involves leading teams in various drug substance technical areas, overseeing the preparation and execution of Technology Transfer, Process Scale-up, and Clinical & Commercial Manufacturing Support during the start-up of a new Drug Substance production facility.
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Responsibilities
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
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
Qualification
Required
Doctorate degree and 3 years of experience
Master's degree and 7 years of experience
Bachelor's degree and 9 years of experience
Associate's degree and 12 years of experience
High school diploma / GED and 14 years of experience
Broad set of expertise across DS with extensive experience, including: 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
Strong technical and management skills, will need to deliver as an individual and team lead
Strong collaborations skills, track record of team environment success
Benefits
With benefits
Company
3 Key Consulting, Inc.
3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries.
51-200 employees
H1B Sponsorship
3 Key Consulting, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (6)
Funding
Current Stage
Growth StageLeadership Team
Ahmad Hussein
CEO, Executive Talent Acquisition, Business Development Leader
Recent News
2025-09-29
Company data provided by crunchbase