Senior Manufacturing Project Lead Position Available In Wake, North Carolina

Job Description:

FUJIFILM

Diosynth Biotechnologies is building the future ofbioproduction in Holly Springs, North Carolina. By end of 2025,we’ll open North America’s largest end-to-end CDMObiopharmaceutical manufacturing facility, offering drug substanceproduction, fill-finish, and packaging under one roof. We’relooking for passionate, mission-driven people to help us realizethis exciting vision and deliver the next vaccine, cure, ortherapy. We offer a dynamic work environment and we’re proud tocultivate a culture that will fuel your purpose, energy, anddrive—what we call Genki. Ready to shape the future of medicine?

Let’s transform healthcare together! Holly Springs, North Carolina,combines small-town warmth with proximity to Raleigh’s thrivingtech scene, making it the perfect blend of community andopportunity. What You’ll Do During the

Project Phase:

• Leadsoperational readiness initiatives as well as site commissioning andqualification efforts
• Manages cost and schedule execution ofproject delivery items and manufacturing operational projects
• Supports organization and development of operational readiness

InOperations:

• Leads manufacturing focused projects at the requestof leadership
• Actively participates and collaborates to meet theneed and expectations set forth by Factory X initiatives and othercross site projects, as assigned
• Supports materials managementwithin manufacturing
• Drives column packing and changeoveractivities including the generation of documents
• Leadsmanufacturing support items which could include, but not limitedto: o Manufacturing change controls and corrective and preventiveactions (CAPAs) o Short flow investigations and alert/action limitso Finite manufacturing schedules o Continuous improvement,escalation, and mitigation of manufacturing issues o Cross site orlocal manufacturing projects o Technology transfer manufacturingdeliverables o Assist in regulatory inspections and audits oPerform other duties as assigned.

Basic Requirements

• High SchoolDiploma or GED
• 12 years of related experience PreferredRequirements
• Associate’s Degree in Life Sciences or Engineering10 years of direct experience OR
• Bachelor’s degree in lifesciences or engineering 8 years of direct experience OR
• Equivalent Military experience/training
• Previous experience in acGMP manufacturing environment
• Relevant experience in CAPEX/OPEXprojects
• Ability to lead teams, facilitate workshops andeffectively communicate project status
• Experience in campaignlifecycle activities
• Understanding of manufacturing equipment,operations, and cadence
• BioWorks or BTEC Capstone cGMP courseworkpreferred

PHYSICAL REQUIREMENTS

• Ability to discern audible cues

PHYSICAL DEMANDS

• Ability to stand for prolonged periods of time.
• Ability to sit for prolonged periods of time.
• Ability toconduct activities using repetitive motions that include wrist,hands and/or fingers.
• Ability to conduct work that includesmoving objects up to 10 lbs.

ENVIRONMENTAL CONDITIONS

• Will workin heights greater than 4 feet