Aditi Consulting
Engineering Associate Director
Aditi Consulting, Holly Springs, North Carolina, United States, 27540
Overview
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 of a 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 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 + 3 yrs, Master’s + 7 yrs, Bachelor’s + 9 yrs, Associate’s + 12 yrs, or High School/GED + 14 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 U.S. is:
$70.00 - $75.00/hr . 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, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance. AI and communications:
Aditi Consulting 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. Privacy and consent:
By submitting your application for this position, you consent to receive text (SMS) and/or email communication, whether automated or individually, from Aditi Consulting at the phone or mobile number and/or email address you have provided regarding potential opportunities and information. You may revoke your consent at any time by emailing privacy@aditiconsulting.com. Message and data rates may apply. Message frequency may vary. Privacy policy:
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (https://www.aditiconsulting.com/privacy-policy).
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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 of a 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 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 + 3 yrs, Master’s + 7 yrs, Bachelor’s + 9 yrs, Associate’s + 12 yrs, or High School/GED + 14 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 U.S. is:
$70.00 - $75.00/hr . 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, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance. AI and communications:
Aditi Consulting 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. Privacy and consent:
By submitting your application for this position, you consent to receive text (SMS) and/or email communication, whether automated or individually, from Aditi Consulting at the phone or mobile number and/or email address you have provided regarding potential opportunities and information. You may revoke your consent at any time by emailing privacy@aditiconsulting.com. Message and data rates may apply. Message frequency may vary. Privacy policy:
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (https://www.aditiconsulting.com/privacy-policy).
#J-18808-Ljbffr