Leidos is seeking a Purification Specialist who will lead a purification 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 purification systems as they are applied to the downstream processing of proteins and products derived from 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.
- Supports successful implementation of new products and processes into the facility.
- Assist with technology transfer from Process Development to manufacturing environment.
- Plan, order and account for consumption of raw materials and components.
- Prepare equipment and supplies for use in cleanroom environment.
- Prepare and maintain reports and other documentation as applicable to the scope of operations in the manufacturing facility.
- Prepare and revise batch records and standard operating procedures (SOPs), as well as draft technical reports.
- Coordinate sample testing and room release with QA/QC.
- Assist in the installation, maintenance, cleaning and operation of bioprocess equipment including chromatography systems, TFF systems, centrifuges, analytical equipment, and clean-in-place skids.
- Ensures that SOPs and batch records are accurate, and followed in accordance with cGMP regulatory expectations.
- Conducts purification operations with an excellent understanding and knowledge of isolating and purifying proteins, antibodies, etc. from microbial and cell culture processes.
- 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 and/or logbooks in a timely manner per established targets.
- Collaborate with the QA to fulfill quality management goals and ensure the highest quality manufacturing processes. Participates in QA training programs as required.
- Identify areas for improvement in manufacturing efficiencies and compliance.
Assists with process, equipment, and cleaning validation initiatives.
- Trains, coaches, and mentors manufacturing associates on downstream manufacturing functions, including compliance on all company/regulatory quality systems, safety procedures, and SOPs.
- Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations.
- Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer
- Ensure high standards of cGMP are adhered to at all times
- BS with a minimum of 4 years of experience in protein purification and protein chemistry (or MS with 3 years of experience) with increasing responsibilities; preferably a manager-level position
- Must also have four years of managerial/supervisory experience.
- Experience with cGMP and down-stream processing of biologicals.
- Experience in HPLC protein purification methods.
- Experience in column packing and chromatography (HIC, IEX, Affinity)
- Experience with processes including cell disruption.
- Experience in operation and maintenance of tangential flow filtration devices, UF/DF operations, and aseptic filtration
- Proficiency in technical writing of SOPs, development and validation reports
- 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).