Kincellis Advanced Therapies is a U.S.-based contract development and manufacturing organization supporting advanced-therapy developers from early-stage CMC, process and analytical development through clinical supply, pivotal-stage programs and commercial supply. With facilities in Gainesville, Florida; Research Triangle Park, North Carolina; and The Woodlands, Texas, Kincellis combines broad technical expertise with flexible, scalable GMP infrastructure across autologous and allogeneic therapies, including but not limited to CAR-T, Tregs, CAR-NK, MSCs, dendritic cell vaccines, exosomes, iPSCs & synthetic mRNA. For more information, visit our website at www.kincellis.com. Essential Duties and Responsibilities Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document. Utilize proficiency in Microsoft Word, Excel, PowerPoint, and other relevant applications to support manufacturing operations. Apply knowledge of aseptic processing, cell culture, and cell therapy manufacturing within a cGMP-regulated environment. Maintain strict adherence to personal protective equipment (PPE) requirements to ensure a safe and compliant workspace. Collaborate with cross-functional teams to draft, revise, and maintain Standard Operating Procedures (SOPs). Perform Quality Control (QC) evaluations as part of in-process and final product assessments within the manufacturing environment. Demonstrate an understanding of material flow and proper disinfection procedures for transferring materials into cleanroom areas. Take personal responsibility for maintaining a safe work environment and completing all assigned training requirements on time. Partner with the Investigation team to support root cause analysis and
Role overview
Job description
About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fosterin
β¦What they are looking for
Skills & requirements
Qualification
Support process performance qualification, engineering runs, media fills, and commercial process monitoring; Support equipment design reviews, user requirements, commissioning, qualification, FAT/SAT, and operational readiness activities; Education and Experience: Bachelorβs degree in chemical engineering, Biochemical Engineering, Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, Life Sciences, or related technical discipline required; Advanced degree in engineering, pharmaceutical sciences, biotechnology, or related discipline preferred
Department Β· Manufacturing/Production

Hiring company
Nivagen Pharmaceuticals
View the company profile, current openings and hiring details.
Related opportunities
Similar active roles
Relevant, currently active roles for this market.
π Get job alerts
New Aseptic Process Engineer jobs in Sacramento, CA 95834, straight to your inbox.
No spam Β· Unsubscribe anytime