Specialist Manufacturing - Aditi Consulting
Thousand Oaks, CA
About the Job
Summary:
This role requires a technically skilled professional with at least five years of GMP experience, where hands-on expertise in manufacturing processes, particularly upstream in drug substance, is highly valued. While a scientific degree is preferred, practical experience in GMP environments and managing quality records takes priority. Strong team leadership and facilitation skills are essential for coordinating projects efficiently.
Responsibilities:
Top 3 Must Have Skill Sets:
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
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.
#AditiConsulting
This role requires a technically skilled professional with at least five years of GMP experience, where hands-on expertise in manufacturing processes, particularly upstream in drug substance, is highly valued. While a scientific degree is preferred, practical experience in GMP environments and managing quality records takes priority. Strong team leadership and facilitation skills are essential for coordinating projects efficiently.
Responsibilities:
- Provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure performance execution across the external manufacturing network.
- Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc. Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.
- Site performance monitoring: Report contract site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by the Work Center Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team.
- Project Management and Technology transfers: Follow-up and track activities in a department-wide project from conception to implementation and close-out. Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level.
Top 3 Must Have Skill Sets:
- 5+ years of experience in protein, API, DS, DP, or packaging manufacturing environment.
- 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
- Quality Records: Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
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.
#AditiConsulting
Source : Aditi Consulting
