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The Quality Control Bioassay Analyst works with direction from manager to execute QC cell- and plate-based analytical methods including protein binding assays, cell-based potency assays, cell culture routine maintenance, and residual testing for DNA, Host Cell Protein (HCP), Protein A/G. The QC Bioassay Analyst adheres to GMP compliant laboratory operations in accordance with regulatory guidelines. This role generates analytical results and identify laboratory exceptions, invalid assays, deviations, change controls and corrective and preventative actions (CAPAs). The QC Bioassay Analyst is primarily responsible for executing routine analytical methods in support of manufacturing, and as needed supporting laboratory execution of analytical method transfers and validations. The ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success.
The manufacturing associate in Drug Product Manufacturing will have a primary task for operation of filling line including all tasks related. This role will also support projects which influence manufacturing processes for DPM including training of others. This position will also support and assist in scheduling daily manufacturing activities for the team. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours or shift rotation.
This role will lead and execute manufacturing processing steps and associated activities. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation. Upon transitioning to operations, this position will transition to a day or night shift that will be defined prior to the transition.
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 Supervisor position supports our night shift, with a shift schedule of Monday-Friday 8pm-4am EST. There is a 20% shift differential for night shift.
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*
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