Associate Technician Operations

Our Manufacturing Operations teams are the people that make therapies for our patients. We work in the manufacturing plants with a “Safety First, Quality Always” mindset, striving for continuous improvement, and earn our right to produce. We work in local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished products. This role is within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse. As the team transitions from PPQ to commercial manufacturing the Associate Technician will play a critical role in, partnering with internal stakeholders and building the operations team. Members of the Operations team in this new and exciting facility will have the unique opportunity to give input in the design process, startup their areas, and lead the teams to full production. Our ability to excel depends on the integrity, knowledge, imagination, skill, , and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. Responsibilities may include but are not limited to: Project Support Supports project team as operations expert in PPQ through licensure and ramp up of facility. Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while coordinating with appropriate personnel. Actively participate in team meetings, waste walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required. Operational Expertise Competent execution and ownership to meet production targets for area within responsibility including: Attending and escalation of concerns or needs at daily huddles and as needed Cleaning, setup, operation and troubleshooting of equipment and facilities Maintenance and transportation of consumable and material inventories Maintenance of excellent recordkeeping and housekeeping Drives culture of continuous improvement. Implements and raises ideas to increase success of group Participates on and/or performs activities to support technical functions such as Kaizen events, ad-hoc sampling, or protocol execution. Maintains detailed knowledge of equipment and processes. Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel.

Minimum Requirement: High School Diploma/GED or higher Required Experience and Skills: At least two (1) years of GMP manufacturing/processing experience, or a Bachelor’s degree in Life Science or Engineering Demonstrated written and verbal communications skills Must be able to successfully pass and maintain aseptic gowning qualifications. Aseptic gowning requires that all skin and hair be covered through wearing the following: beard/mustache cover, hair net, hood and facemask, goggles, jumpsuit, gloves, and boots. Computer literacy (internet browsers, e-mail, spreadsheets, word processing) Must be willing and able to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator This position is for second shift, Mon-Fri (2:00pm-10:30pm). Successful completion of TB titer and Chest X-ray are required. Preferred Experience and Skills (General): Minimum Associates Degree in science or related field Bioworks Certificate (working in an FDA or similar regulated industry) Applicable mechanical and project management experience Experience with automated systems (MES, SAP, DeltaV, or similar) Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements and Good