Engineering Associate Director

New Today

Payrate: $ - $
Summary:
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.
Responsibilities: 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 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.
Work cross-functionally with individuals and project teams in Process Development, Manufacturing, Quality, and Facilities and Engineering
Create and assess technical assessments to support deviations and validations
Create and execute 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 + yrs, Master’s + yrs, Bachelor’s + yrs, Associate’s + yrs, or High School/GED + yrs of experience.
Top Must Have Skill Sets: Strong technical and management skills, will need to be delivered as an individual and team lead
Strong collaborations skills, track record of team environment success
Pay Transparency: The typical base pay for this role across the is: $ - $ Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, paid days off, (k) plan participation, commuter benefits and life and disability insurance.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying to this position, you agree to Aditi’s use of AI technology, including calls from an AI Voice Recruiter.
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AditiConsulting
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Location:
Holly Springs
Job Type:
FullTime

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