Associate Scientist - Philadelphia, United States - Blue Ocean

Blue Ocean

Verified Company

Philadelphia, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations is required.

Specific Responsibilities

Develop a comprehensive understanding of and be able to proficiently execute current cell therapy manufacturing process.
Complete training sessions and ensure training documentation is maintained.
Understands and complies with quality standards and requirements as documented.
Provides operational support functions including materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.
Supports technical transfer and additional research level testing activities.
Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
Support documentation needs, which may include drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
Attends the daily lab meeting and escalates issues/concerns at that forum to Area Management for further investigation.
Ability to work in a team environment and independently as required. Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.