Senior Manufacturing Technician, Bioprocess

The Senior Manufacturing Technician is responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in a cGMP manufacturing environment, while maintaining working areas in a high state of inspection preparedness.

This individual will operate production equipment for cell culture or purification that may include media/buffer solution preparation, culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer.

Utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP), you are responsible for accurate record maintenance, as well as keeping the clean room environment compliant with regulatory requirements at all times.ResponsibilitiesOperate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20L bioreactors; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.Operate systems that clean and sterilize tanks and filtration systems, including bioreactors, centrifuges, other harvest systems and protein purifications units.Prepare solutions for the production process.Operate and clean fixed tank and filtration systems.Operate large scale column chromatography systems.Perform CIP and SIPReview documentation and check all calculations (e.g.

tickets, labels, equipment reading).Troubleshoot equipment and process problems.Comply with safety requirements, cGMP, SOP and manufacturing documentation.Assemble and prepare equipment for production.Operate automated systems for equipment and production operations.Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.Provide support to Manufacturing to meet production demandsFollow established safety and environmental guidelines and procedures for all work performed.Provide coaching and training on best practices and compliance to SOPs.Participate in continuous operational improvement.Anticipates potential problems and takes preventative action.Requires judgment to know when it is necessary to consult with supervisor and/or support groups.Understands how own actions impact others and uses this information in decision-making.Qualifications Bachelor’s degree preferably in Life Sciences or engineering, or Associate degree and 5+ years related experience , o r High School diploma and 5+ years related experience.Biotech certificate from approved program desirable.Understands the theory, concepts, and regulations behind biopharmaceutical technology and processes.High level of automation and technical process knowledge as related to prep and process within area of responsibility.A strong knowledge of at least one manufacturing department with an understanding of process impact of other areas.Background in fermentation or purification operation.Excellent oral and written communication skillsCapable of writing detailed reports and summaries.Familiarity of computer-based systems.Communicate effectively.Professional interpersonal skills.High attention to detail.Physical Demands/Work Environment/Safety Considerations Schedule could include a non-rotating 3 or 4-day (12 hour shift including one weekend day), evening or night hours, or full off-shift hours.Expected to be on feet for 8 to 10 hours a day.Climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility.Lift up to 40 lbs, Carry 40 lbs, Push/Pull force of 50lbs with full body, and Push/Pull force of 24lbs with arms only may be required.The clean room environment requires: Gowning in the form of hospital scrubs, coveralls, gloves and steel toe boots must be wornNo make up or jewelry can be worn when working in the clean room environmentWork in clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a loud environment.Work with hazardous materials and chemicals.#LI-TS2 #PTcareers