Overviewis seeking an accomplished scientific leader to oversee antibody and resin production in support of the
VICAM® column production value stream. In this critical role, you will collaborate closely with Research & Development, Engineering, and Manufacturing teams to ensure the reliable, on-time production of antibodies and resins that meet quality, capacity, and operational requirements. The successful candidate will drive process excellence, optimize production performance, and ensure a consistent supply of key materials to support customer demand and the ongoing success of the column production line.
ResponsibilitiesCell Culture Operations- Retrieve, thaw, and initiate mammalian cell lines from cryogenic storage
- Monitor culture health, morphology, viability, and contamination status
- Perform routine passaging and expansion of cell cultures
- Maintain safety-stock cultures and frozen cell banks
- Perform sterile manipulations within biosafety cabinets
Seed Train Expansion- Expand cultures through multiple vessel scales to generate inoculum
- Evaluate expansion readiness based on growth phase and culture condition
- Perform aseptic transfers, media additions, and feeding activities
- Maintain proper labeling and tracking of cultures
Bioreactor Setup & Operation- Install and prepare single-use cultureware systems
- Perform system pressurization testing and leak checks
- Execute fill, flush, and priming procedures
- Perform bioreactor inoculation activities
- Monitor process parameters including temperature, pH, dissolved oxygen, and gas supply
- Collect in-process samples for routine analysis
Cryopreservation & Cell Banking- Harvest cultures for long-term storage
- Prepare freezing suspensions using appropriate cryoprotectants
- Aliquot into cryovials and perform controlled freezing steps
- Maintain cryogenic storage inventory and records
Documentation & Compliance- Maintain accurate batch records and laboratory documentation
- Record culture observations, process steps, and test results
- Follow established SOPs and aseptic handling procedures
- Adhere to safety and biosafety requirements
QualificationsEducation & Qualifications- Advanced degree in a relevant field - Bachelor Degree in Cell Biology, Molecular Biology, Bioengineering, Biotechnology, or related discipline required, MS preferred.
- Extensive research and development experience in cell culture, cell line development, or bioprocess engineering.
- Industry experience in biologics, cell therapy, or related manufacturing environments.
- Aseptic technique and sterile handling
- Mammalian cell culture fundamentals
- Laboratory safety and biosafety practices
- Basic bioreactor operations
- Microscopy and culture assessment
- Accurate record keeping and documentation
- SAP ERP Systems
Key WordsCell culture, Materials Science, Particle Synthesis, Organic Chemistry
