We are looking for a skilled professional to join our team in a highly specialized role. About the Job:
The Technical Expert will be responsible for overseeing technical activities related to commercial manufacturing processes at contract manufacturing organizations (CMOs). This includes authoring change control documents, managing process improvement projects, and analyzing process performance.
In addition, the Technical Expert will be involved in technical transfer activities, as applicable, by drafting and/or reviewing Good Manufacturing Practice (GMP) documentation and regulatory filings. They will also provide on-site support at external partner sites to ensure compliance with GMP requirements and current regulations.
Key Responsibilities:
* Manage technical activities related to commercial manufacturing processes at CMOs
* Author and review GMP documentation and regulatory filings
* Provide on-site support at external partner sites
Requirements:
1. Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field
2. Minimum 4 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area
3. Strong communication and teamwork skills
4. Proven expertise in biologics drug substance upstream and downstream operations, analytical testing, process development, and tech transfer
5. Demonstrated ability to independently manage projects/work to schedule/deadlines
6. Statistics experience (including proactive process analysis and continuous process verification)
7. Experience in deviation management and/or change control and/or equipment support, and/or project management
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