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The Manufacturing Associate 3, Drug product is responsible for Component/Parts Preparation, Thawing and Formulation of Drug Substance, Sterile Filling and Visually Inspecting of Drug Product (DP). This role supports projects which influence manufacturing processes for Drug Product Manufacturing including training of new colleagues. Maintains compliance of cGMP documents and to assist in qualification of equipment and all aspects of startup of the DPFG facility. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation
The Manufacturing Associate 3, Drug product is responsible for Component/Parts Preparation, Thawing and Formulation of Drug Substance, Sterile Filling and Visually Inspecting of Drug Product (DP). This role supports projects which influence manufacturing processes for Drug Product Manufacturing including training of new colleagues. Maintains compliance of cGMP documents and to assist in qualification of equipment and all aspects of startup of the DPFG facility. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation
The Manufacturing Associate 2 executes and documents manufacturing processing activities per cGMP environment. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.
We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams who are willing and able to work on a DAY SHIFT (Approximately 6:00AM-6:00PM).
These roles will execute manufacturing processing steps and associated activities when operational. You will also participate in operational readiness projects and commissioning/qualification projects. Our brand-new facility will be 24/7 operational and our manufacturing teams work 12-hour shifts on a 2-2-3 calendar rotation.
*** Please note that this posting represents multiple openings within our manufacturing organization ***
We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams who are willing and able to work on a NIGHT SHIFT (Approximately 6:00PM-6:00AM).
These roles will execute manufacturing processing steps and associated activities when operational. You will also participate in operational readiness projects and commissioning/qualification projects. Our brand-new facility will be 24/7 operational and our manufacturing teams work 12-hour shifts on a 2-2-3 calendar rotation.
*** Please note that this posting represents multiple openings within our manufacturing organization ***
This Utility Operator 3 position supports our night shift. This is a 2/2/3 work schedule from 6pm-6am.
The Utility Operator 2 operates, maintains, and repairs black and clean utility systems. This position is also responsible for monitoring mechanical and electrical equipment, power distribution, chilled water, process gas, domestic and de-ionized water, water for injection (WFI), clean steam generator and distribution, plant steam boilers, compressed air, fire alarm, security, remote building equipment monitoring, sanitary, acid waste, and storm drain systems. Additionally, this role performs daily monitoring of tank farm, supports lab admin building, building management system (BMS) and critical alarm response.
This Supervisor position supports our night shift, with a shift schedule of Monday-Friday 8pm-4am EST.
The Supervisor of Utility Operations is responsible for overseeing and coordinating the operations of utility systems and the team of utility operators to ensure smooth and efficient operations. This role focuses on maintaining and managing equipment, vendors, and daily operational activities while ensuring compliance with safety, regulatory, and Good Manufacturing Practices (GMP) standards. Additionally, this role also provides training, technical support, and leadership to the utility operations team.
The Director, Engineering Science plays a pivotal role in providing technical leadership and strategic vision within the Manufacturing Science and Technology (MSAT) of the organization. This role assesses and designs processes to integrate new equipment, optimize facilities, and enhance operational capabilities. The Director, Engineering Science leads engineering studies, drives improvements in Drug Substance Manufacturing (DSM), Drug Product and Finished Goods (DPFG), and ensures innovative solutions are implemented effectively. This role is crucial in enhancing site’s process equipment and technology capability offerings and maintaining competitiveness, by making significant contributions to the company’s growth and innovation.
This role leads a shift team and is responsible for manufacturing bulk drug substance. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.
As an upstream supervisor, you’ll lead and inspire a team of manufacturing associates, supporting the start up of a new large scale cell culture facility. The Upstream area includes: An inoculum lab, two seed reactor trains (each with 4 reactors of increasing size), four 20,000L production reactors, a harvest suite, media preparation, and parts prep area.
You and your team will work a 2-2-3, 12 hour shift schedule to support the ongoing activities in these areas.
You’ll start out leading a team in project phase supporting commissioning and qualification efforts in addition to helping prepare the facility to be operational ready. It’s an exciting opportunity to help build out processes and procedures in preparation of the first GMP run later this year.
*Relocation Assistance Available*
The Sr Automation Engineer 1, DSM, DeltaV Infrastructure, will provide Engineering input on the design, implementation, configuration, and testing/qualification of hardware for an Emerson DeltaV control system. Once in Operations, you will be responsible for and have ownership of the ongoing support of the control system hardware, software, and infrastructure.
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