5 Research Court, Rockville, MD, USA, 20850 Pay rate: $31.50/hr. on W2
Duration:
6+ months contract (Possibly convert into full-time) Shift timings: 8:00 am - 4:30 pm (Monday to Friday)
Position Summary:
The Sr. Biomanufacturing Associate plays a key role within gene therapy manufacturing function by applying biological, bioprocess, manufacturing, mechanical, application, system, and technology, principles, processes, procedures, inputs, and outputs, for designated production processes and handovers within a regulated environment to ensure the timely production and release of quality products, based on client specifications. This role will independently and effectively apply experience and in-depth technical knowledge across a range of floor-level tasks (from start to finish), some of which are complex, requiring independent action and initiative when executing manufacturing protocols.
Key Responsibilities and Duties:
Apply and adhere to SOPs, cGMP, GLP, Quality, and Safety requirements. Independently execute floor-level tasks, in line with SOPs in one or more areas: Downstream Activities Fill-Finish Activities Assist in coordinating and executing floor activities, in alignment with the batch record. Apply advanced GDP when preparing, editing, reviewing, and implementing Quality documents. Perform daily BPR reviews to ensure completion. Participate in/co-lead GMP audits and investigations. Ensure high data integrity when accurately documenting, analyzing, and reviewing work. Prepare, clean, maintain, inspect, and operate equipment; assist with calibrations. Troubleshoot routine to moderately complex issues, using root cause analysis. Co-lead health and safety prevention initiatives to reduce risk. Comply with safety regulations and site-based guidelines by applying: Cleanroom and aseptic behaviors and procedures. PPE and gowning requirements. Proper preparation, disinfection, sterilization, and sanitation methods/processes for equipment, etc. The safe handling, transport, storage, and disposal of biological specimen, chemical, and hazardous materials. Understanding of biosafety levels and applying specific controls. Universal precautions/OSHA guidelines. Assistance in training others to avoid accidents or other unsafe situations. Assist in mentoring and training others; share knowledge and best practices. Provide recommendations and implement Continuous Improvement/LEAN solutions to create efficiencies. Ensure 100% on time completion of own/others training plans; ensure they are maintained and up to date. Be punctual and flexible with work schedule, tasks, etc. to support business demands. Perform other responsibilities as required.
