Vacancy expired!
- clinical-stage cell-therapy company, targeting tumor cells
- A pipeline of 4 different cells, pre-clinical and phase 1
- around 90 employees in the Bay Area
- IPO date: July 2020 - raised $160M
- Supports activities for releasing or rejecting intermediates, API, drug substance, and drug products.
- Reviews completed batch production and laboratory control records of critical process steps before release of the product for distribution.
- Reviews of Quality Control analysis and results to support product release.
- Releases or rejects raw materials, intermediates, packaging and labelling materials.
- Conducts Quality on the Floor activities including, but not limited to, quality walk-throughs, change-over and line clearance. Assists on changes that potentially impact intermediate or API, drug substance, and drug product quality.
- Assists in the investigation and resolution of quality related complaints
- Participates in cross-functional collaborations to meet project timelines and material supply requirements
- 2+ years of experience in pharmaceutical QA and working with CMO's
- Bachelors degree in Biology, Chemistry
- Excellent communication skills, both written and oral
- Experience in working in a biotech start-up.
- Experience with cell therapy production processes and viral transduction principles and processes is highly preferred.
- Integrity, confidence, passion and collaborative spirit are highly valued.
- Willingness and ability to travel up to 10%.
Vacancy expired!