Leidos is seeking a Fermentation Specialist who will lead a production team at a manufacturing facility in Silver Spring, MD. S/he will perform duties associated with the design, start-up, evaluation, validation, and maintenance of fermentation systems as they are applied to the fermentation of prokaryotic and eukaryotic cells. Fermentation harvests will be processed and purified so that end products can be used for human vaccines and biological products.
This position is contingent upon contract award
- Plan schedules for fermentation of desired materials.
- Make recommendations for production of desired products based on research data received from research personnel.
- Responsible for all levels of fermentation, from bench scale to 400 liters.
- Responsible for process development when this is necessary prior to full-scale production.
- Responsible for optimizing growth of various prokaryotic and eukaryotic cells so that optimal yields are available for processing.
- Operate bioprocess equipment under strict adherence to cGMP, OSHA and required policies and regulations.
- Recognizes and escalates bioprocess operational risks to team lead or Manager prior to failure, to ensure safety and compliance requirements.
- Recommends and executes projects and changes to bioprocess operations to reduce risk and increase efficiency.
- Performs in-process assays to monitor process performance.
- Responsible basic trouble-shooting of technical issues and other problems encountered within the manufacturing process. Write deviation incident reports as needed.
- Carry out the manufacturing review (as delegated) of the completed batch record logbooks in a timely manner per established targets.
- Collaborate with the Quality Assurance group to fulfill quality management goals and ensure the highest quality manufacturing processes. Participates in QA training programs as required.
- Depending on the desired product, will harvest cells intact, or when desired, process cells through various stages of downstream processing using various types of equipment to accomplish this.
- Responsible for writing Standard Operating Procedures, Batch Production Records, and any other documents that are required to maintain documentation and compliance with current Good Manufacturing Practices.
- Ensure that all data is entered in records to be maintained on file for each product.
- BS degree in Engineering or the Life Sciences; 10 years' experience operating fermentation under GMP.
- 15 total years' experience in the biotechnology field.
- Must also have four years of managerial/supervisory experience.
- Professional knowledge of the principles and practices applicable to fermentation and downstream processing.
- Knowledge of operation of bioreactors from bench capacity to 400 liters.
- Knowledge of operation of centrifuges, ultrafiltration, and cell disruption equipment.
- Familiarity with related fields such as microbial physiology, general microbiology, microbial fermentation, mammalian cell culture, physical chemistry, and biochemistry. This knowledge could be acquired through formal course work or by experience in the field.
- Extensive knowledge of Good Manufacturing Practices as applied to biological products.
- Current documented training in GMP regulations, preferred
- All proposed personnel to perform services contractor must verify employment eligibility (E-Verify) and obtain a favorable National Agency Check (NACI).