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Associate Scientist

5 months ago

Philadelphia, United States Blue Ocean Full time

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.

**Job Type**: Contract

Pay: From $26.00 per hour

Schedule:

- 10 hour shift
- 12 hour shift
- 8 hour shift
- Day shift
- Monday to Friday

**Education**:

- High school or equivalent (preferred)

**Experience**:

- Cell culture: 1 year (preferred)
- GMP: 1 year (preferred)
- Aseptic technique: 1 year (preferred)
- SOP: 1 year (preferred)

Work Location: In person