Manufacturing Process Improvement Specialist

5 days ago


Lexington, Kentucky, United States Genezen Full time
Company Overview
Genezen is a biotech company that provides process development, GMP viral vector production, and cell transduction for gene and cell therapy clinical trials. Our mission is to empower employees to be their best and make Genezen a rewarding place to work.

Job Description
The Manufacturing Process Improvement Specialist will be part of a cohesive team responsible for Deviation investigations, CAPAs, and Change Controls for all phases of manufacturing. This role requires expertise in cGMP regulations and project management to ensure manufacturing readiness and compliance. The incumbent will also support equipment, documentation, and process operations improvement initiatives within Manufacturing.

Required Skills and Qualifications
This position requires a minimum of 2-3 years of related industry experience in biomanufacturing unit operations (USP and/or DSP). Essential skills include the ability to apply systems thinking as part of problem-solving, industrial empathy when working with stakeholders, and detail-oriented self-organization. Strong communication and technical writing skills are also necessary. Additionally, this role requires adherence to company internal and regulatory policies, processes, and procedures.

Benefits
Genezen offers a competitive salary of $90,000 per year, paid vacation days based on tenure, paid sick time, 9 observed holidays + 1 floating holiday + 1 volunteer day, 401(k) plan with company match up to 6% of salary, vested immediately, and other benefits including Share Appreciation Rights, Choice of several healthcare plans, FSA and HSA programs, Dental & vision care, Employer-paid basic term life/personal accident insurance, Voluntary disability, universal life/personal accident insurance, Accidental Death & Dismemberment (AD&D) Insurance.

  • Lexington, Kentucky, United States T2 Biosystems Full time

    OverviewT2 Biosystems is seeking a highly skilled Senior Manufacturing Engineer to join our team. As a key member of the production support group, this individual will play a critical role in promoting product quality, supporting instrument manufacturing, and driving continuous process improvement.Salary$120,000 - $150,000 per year, depending on...


  • Lexington, Kentucky, United States Tiffany and Company Full time

    Job SummaryTiffany & Co. seeks a highly motivated and detail-oriented Manufacturing Intern to support our Manufacturing team in Lexington, KY.Key ResponsibilitiesPartner with Inventory Control to analyze material and data flow, identify bottlenecks, and implement process improvements using available technology.Create, update, and maintain concise...


  • Lexington, Kentucky, United States T2 Biosystems Full time

    Job OverviewWe are seeking a skilled Manufacturing Engineer to support our instrument manufacturing operations.Key ResponsibilitiesCollaborate with the instrument manufacturing team to drive quality and efficiency.Develop and implement manufacturing quality processes to ensure compliance with regulatory requirements.Identify opportunities for process...


  • Lexington, Kentucky, United States Genezen Full time

    About GenezenAt Genezen, we are committed to delivering innovative solutions for gene therapy. Our team is passionate about empowering employees to make a meaningful impact in the field of biotechnology.Job OverviewWe are seeking an experienced Biotechnology Manufacturing Specialist to join our team. As a key member of our manufacturing group, you will be...


  • Lexington, Kentucky, United States Genezen Full time

    About GenezenGenezen is a leading company in the field of gene therapy, providing process development, GMP viral vector production, and cell transduction for gene and cell therapy clinical trials.We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance...


  • Lexington, Kentucky, United States Genezen Full time

    Company OverviewGenezen is a leading company in the field of gene therapy, dedicated to meeting the exacting needs of our clients. We provide process development, produce GMP viral vectors, and offer cell transduction for gene and cell therapy clinical trials.About the RoleWe are seeking a skilled Manufacturing Operations Specialist to join our team at...


  • Lexington, Kentucky, United States Genezen Full time

    About GenezenGenezen is a pioneering biotechnology company dedicated to revolutionizing gene therapy and advancing healthcare. Our mission is to deliver timely treatments to patients by accelerating our partners' programs.We operate with urgency, commitment, and resilience in the face of challenges. We are committed to scientific excellence, staying current...


  • Lexington, Kentucky, United States O'neal Manufacturing Services Full time

    Job Overview O'neal Manufacturing Services is seeking a skilled Master Inventory Management Specialist to join our team. As an expert in order fulfillment, you will play a crucial role in ensuring the timely and accurate delivery of materials to our customers. Key Responsibilities Monitor and verify all receiving reports to guarantee the accuracy of...


  • Lexington, Kentucky, United States Lockheed Martin Corporation Full time

    About UsWe are a leading manufacturer of advanced technology systems for defense, space and commercial applications. Our team is dedicated to delivering innovative solutions that meet the needs of our customers.Job SummaryWe are seeking an Industrial Operations Specialist to join our team. As an Industrial Operations Specialist, you will be responsible for...


  • Lexington, Kentucky, United States Smurfit Westrock Full time

    About the JobAs a Corrugated Manufacturing Equipment Specialist at Smurfit Westrock, you will play a crucial role in ensuring the smooth operation of our corrugated container plant in Lexington, KY.Key ResponsibilitiesOur ideal candidate will provide safe and timely mechanical and basic electrical support for equipment installation and preventative...


  • Lexington, Kentucky, United States Boston Children's Hospital Full time

    About Boston Children's HospitalBoston Children's Hospital is a leading pediatric medical center, committed to providing exceptional care and advancing the field of pediatrics.Job OverviewWe are seeking an experienced Sterile Processing Technician III to join our team. This role will be responsible for ensuring the highest standards of sterilization...


  • Lexington, Kentucky, United States Genezen Full time

    About GenezenAt Genezen, we are dedicated to delivering cutting-edge solutions in the field of gene therapy. Our team is passionate about empowering employees to be innovative problem solvers who drive our company's success.Job SummaryThis role will focus on performing routine and non-routine manufacturing operations, ensuring compliance with cGMP quality...


  • Lexington, Kentucky, United States Hawkins HR Consulting, LLC Full time

    Hawkins HR Consulting, LLC is seeking a highly skilled Process Engineer to join their team in Lexington. This 40-45 hour per week position offers the opportunity for professional growth and development in a non-union manufacturing environment.About the RoleThe Process Engineer will provide technical support to the manufacturing floor, leading or assisting...


  • Lexington, Kentucky, United States Takeda Pharmaceutical Full time

    About the Role:As a Senior Staff Engineer, Modeling at Takeda Pharmaceutical, you will play a critical role in supporting process development and optimization of production processes for biopharmaceuticals. Your expertise in modeling approaches will drive innovation and improvement in our manufacturing processes.Responsibilities:Sustainability and economic...


  • Lexington, Kentucky, United States Schneider Electric Full time

    Job OverviewWe are seeking an experienced Manufacturing Operations Lead to join our team in Lexington, KY. The successful candidate will be responsible for driving operational excellence and ensuring the successful attainment of production schedules.About the RoleThis is a leadership position that involves overseeing a team of 20-30 production associates....


  • Lexington, Kentucky, United States Aegis Worldwide Full time

    Aegis Worldwide is a leading firm in the manufacturing sector, seeking an experienced Manufacturing Operations Manager to oversee the smooth operation and maintenance of plant equipment, processes, and infrastructure. This critical role offers a unique opportunity for an engineering professional to lead both departments and drive success.Estimated Salary:...


  • Lexington, Kentucky, United States Walmart Full time

    About the JobWe are seeking a highly skilled Receiving and Processing Specialist to join our team at Sam's Club in Lexington, KY. In this role, you will be responsible for maintaining and processing shipments for the Club in accordance with Company policies and procedures.Job SummaryThe ideal candidate will have experience working in a warehouse environment...


  • Lexington, Kentucky, United States Takeda Pharmaceutical Full time

    Join Takeda Pharmaceutical as a Chemical Process Lead and take on the challenge of leading technology transfer activities from bench to pilot and manufacturing scales.We are seeking an experienced professional with a Master's degree in Bioengineer, Biology, Chemical Engineer, Chemistry or related field, plus 3 years of related experience.Your key...


  • Lexington, Kentucky, United States Takeda Pharmaceutical Full time

    Takeda Pharmaceutical is seeking a highly skilled Purification Process Engineer to join our team in Lexington, MA. As a key member of our biotherapeutics process development team, you will be responsible for designing and executing purification unit operation, development, characterization, and optimization experiments.About the Role:Independently plan and...


  • Lexington, Kentucky, United States Tempur Sealy International, Inc. Full time

    Company OverviewTempur Sealy International, Inc. is a leading designer, manufacturer, distributor, and retailer of bedding products worldwide. With a commitment to improving the sleep of more people, every night, all around the world, we strive to be at the forefront of our industry.About the RoleWe are seeking a highly skilled DTC Operations Specialist to...