Provide sample management and associated logistical support during a drug substance process validation campaign.
Create and maintain master sample plan by assembling sampling requirements from all applicable activities, laboratories, and stakeholders associated with the process validation campaign.
Maintain and enforce sample management workflow and processes.
Provide data verification and documentation support to ensure alignment of the master sample plan with GMP documentation such as protocols, reports, manufacturing batch records, and laboratory information system (LIMS).
Support ad-hoc, supplemental sample requests utilizing a paper based or electronic sample request workflow
Coordinate with sample requestor and manufacturing on ad-hoc/supplemental sample requests.
Daily coordination with manufacturing to confirm that sampling plan and sampling requirements are understood and followed
Periodic check-in with laboratories and sample requestor on the receipt of samples.
Escalation and coordinate resolution of sampling related issues including, but not limited to, missed samples, production plan changes, and sample plan changes.
Query and collate laboratory results from submitted samples; provide data verification and documentation support to summarize laboratory results in validation and technical reports.
Provide supplemental logistical, administrative, and documentation support for the preparation of, and the duration of the process validation campaign. This can involve responsibility for campaign closure activities.
Provide sample label generation support and coordination of label placement in the manufacturing batch records.
Bachelor's Degree in science field or related discipline preferred.
Great communication skills.
Technology Transfer background with biologics manufacturing.
Pharma industry experience.
LIMS experience strongly preferred.
Understanding concept of large scale biologics manufacturing.
Attention to detail.
Used to processes and procedures (SOPs) in a cGMP environment.