OverviewChenega Services and Federal Solutions, LLC., a
Chenega Professional Services' company, is looking for a
Cell Culture and Hybridoma Technical Lead to provide laboratory and technical support for cell culture and hybridoma operations within the Virology Division. The position supports cell line maintenance, hybridoma production, quality control testing, SOP management, laboratory inventory activities, equipment management, data archival, and laboratory operations. The incumbent maintains cell culture resources, ensures compliance with applicable SOPs and Good Laboratory Practice (GLP) requirements, supports assay activities, trains laboratory personnel, and assists in maintaining operational readiness of laboratory equipment and cell culture resources while supporting research and diagnostic missions.
Responsibilities- Maintain up to 10 cell lines and assist with hybridoma production.
- Perform assays to ensure cell line viability and metabolic activity for each customer order filled.
- Produce, maintain, and archive department records IAW institutional guidance.
- Assist in maintaining approximately 40 Cell Culture specific SOPs. Included, but not limited to, periodic review, revision, writing, and peer review.
- Maintain LN2 Freezer Inventory for Cell Lines and Hybridomas (approximately 75,000 plus vials).
- Maintain inventoried supplies/reagents so that research is not delayed.
- Shall have legible handwriting IAW 21 CFR Part 58.
- Perform and document cleaning of benchtops, Biological Safety Cabinets (BSCs), floors, shelves, and other surfaces on a determined schedule as needed.
- Shall cross-train within the Virology Division to provide assay and technical support as needed.
- Shall adhere to cell seeding/splitting and related technical recommendations of the Cell Culture Section Manager and applicable SOPs to ensure acceptable and consistent product quality.
- Provide technical oversight, mentor and train junior laboratory technical support Contractors.
- Perform monthly mycoplasma testing, and additional QC (quality control) testing on a determined schedule as needed.
- Be responsible for the archival of electronic data generated from all applicable cell culture equipment.
- Shall maintain GLP Equipment Management-ensuring equipment is ready for use and GLP compliant (approximately 100 pieces of equipment) IAW applicable regulations and SOPs. This includes the maintenance of equipment notebooks and the performance of routine QC and calibration checks on all applicable cell culture equipment.
- Ensure existing equipment is maintained in a validated state and shall oversee the validation of existing and newly acquired equipment.
- Cross-train within the Virology Division to provide assay support as needed.
- Other duties as assigned
Qualifications- Bachelor's degree in Biology, Microbiology, Molecular Biology, Biotechnology, Life Sciences, Biomedical Science, or a related scientific discipline.
- Typically requires three (3) to five (5) years of related laboratory experience consistent with a Laboratory Technician 3 labor category.
- Experience performing laboratory procedures, testing, research activities, and technical support functions in cell biology, cell culture, microbiology, virology, biotechnology, or related scientific disciplines.
- Experience maintaining cell lines and supporting cell culture laboratory operations.
- Experience supporting laboratory inventories, documentation, equipment management, and laboratory compliance activities.
- Experience collecting, documenting, organizing, and maintaining laboratory records and data.
- Experience performing quality control procedures and laboratory housekeeping activities.
- Ability to work independently and collaboratively within a laboratory environment.
- Successfully pass background and drug screening
Preferred Qualifications:
- Experience supporting hybridoma production activities.
- Experience performing cell viability, metabolic activity, and quality control assays.
- Experience maintaining large-scale biological inventories including cell banks and LN2 storage systems.
- Experience supporting GLP-compliant laboratory environments.
- Experience maintaining laboratory equipment, calibration records, and validation documentation.
- Experience performing mycoplasma testing and related quality control procedures.
- Experience reviewing, revising, or maintaining SOPs.
- Experience training laboratory personnel and supporting laboratory operations.
- Experience supporting virology or infectious disease research programs.
Knowledge, Skills and Abilities:
- Knowledge of cell culture methodologies, cell biology principles, and laboratory operations.
- Knowledge of cell line maintenance, hybridoma support procedures, and biological sample handling techniques.
- Knowledge of laboratory quality control procedures, mycoplasma testing, and laboratory documentation requirements.
- Knowledge of GLP principles, SOP compliance requirements, and laboratory quality standards.
- Knowledge of laboratory inventory management, LN2 storage systems, and biological material tracking procedures.
- Knowledge of laboratory equipment operation, calibration, validation, and maintenance practices.
- Knowledge of data archival, records management, and electronic laboratory documentation systems.
- Ability to independently perform routine and specialized laboratory procedures following established protocols.
- Ability to maintain accurate laboratory records, inventories, and quality documentation.
- Ability to organize and prioritize laboratory activities while maintaining compliance requirements.
- Ability to train and provide technical guidance to laboratory personnel.
- Strong analytical, organizational, problem-solving, written communication, and verbal communication skills.
- Ability to work independently and collaboratively within multidisciplinary laboratory teams.