Manufacturing Support Associate 3, Drug Product Position Available In Wake, North Carolina

Manufacturing Support Associate 3, Drug Product
Job Locations
US-NC-Holly Springs
Posted Date
5 days ago
(4/14/2025 6:04 PM)
Requisition

ID 2025-34254

Category Manufacturing Company (Portal Searching) Diosynth Biotechnologies
Position The Manufacturing Support Associate 3 plays a crucial role in maintainingpliant and reliable production, with adhering to cGMP regulations and industry guidelines. This position leadspliance initiatives, oversees corrective and preventive action (CAPA) execution, and coordinates batch planning, all while ensuring seamless tech transfer and effective troubleshooting as a process subject matter expert (SME). The role demands flexibility in working hours to effectively support 24/7 production and amodate inspections and audits. Company Follow Your Genki to North America’s largest, state-of-the-art Life Science Manufacturing Facility & CDMO The work we do at Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharmapanies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive – what we call Genki. Join us We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America. The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States. Job Description What You’ll Do

• Collaborates with stakeholders to implementpliance initiatives and carry out regulatory assessments, ensuring full alignment with industry standards andanizational goals
• Promotes a robustanizational structure by effectively overseeing CAPA execution andpliance monitoring to maintain high performance standards, while developing and implementing risk mitigation strategies
• Provides expert guidance on regulatory changes and industry trends
• Serves as a liaison between regulatory bodies and internal teams
• Collaborates effectively with cross-functional stakeholders to coordinate and executeprehensive Annual Product Reviews, ensuring alignment with regulatory requirements and promoting continuous improvement in product quality and process efficiency
• Supports reliable production during regular operations
• Leads troubleshooting as a process subject matter expert (SME)
• Coordinates Batch Planning including process template creation and import and management of preventive maintenance plans (PMs)
• Identifies and/or drives highly technical improvement projects in Drug Product (DP)
• Collaborates with cross-functional teams (e.g., DSM, MSAT, and Tech Transfer) to rmend and perform updates to documentation, ensuring accuracy and alignment with evolving processes and standards
• Coordinates non-batch activities and creation of associated documentation for changeover and PMs
• Initiates or supports change management records, investigations, CAPAs, and continuous improvement (CI) activities
• Provides support during inspections and audits by assisting in the backroom or acting as a runner, ensuring efficient access to required documents and information, while maintaininganized and transparent audit processes
• Performs other duties, as assigned Basic Requirements
• High school diploma or GED with 8 years related experience in life sciences manufacturing OR
• Associate’s Degree in Pharmaceutical Sciences, Biotechnology, Microbiology, or a related field with 6 years related experience in life sciences manufacturing OR
• Bachelor’s in Pharmaceutical Sciences, Biotechnology, Microbiology, or a related field with 4 years related experience in life sciences manufacturing OR
• Equivalent military experience or training Preferred Requirements
• Experience in drug product manufacturing, sterile processing, or quality assurance
• Strong knowledge of cGMP, FDA, EMA, and MHRA
• Experience developing and delivering technical training programs
• Experience with learning management systems

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Ability to stand for prolonged periods of time – Up to 60 Minutes
Ability to sit for prolonged periods of time – Up to 60 Minutes
Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers