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Job Locations US-NJ-Piscataway
Posted Date 4 weeks ago(12/22/2021 10:04 AM)
Under the supervision of Quality Control Manager, the candidate is responsible for the execution of activities for assigned tasks within quality control programs. Responsibilities include the management of the day-to-day QC Raw Material documentation, inspection, sampling, testing, and qualification . Provide support for Quality Events relating to deviations and CAPA’s.
ID
2021-2725
Company
Kashiv BioSciences LLC.
Job Locations US-IL-Chicago
Posted Date 1 month ago(12/17/2021 2:24 PM)
Kashiv is looking for enthusiastic interns with strong desire to learn! The Manufacturing intern will be trained on multiple subjects such as- Drug Substance, Drug Product, visual inspection and Secondary Packaging for clinical and commercial products for human use. You will also be trained to perform tasks following aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning.
ID
2021-2724
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 1 month ago(12/16/2021 1:23 PM)
Kashiv BioSciences, LLC is a fully integrated biosciences company with an expanded and dynamic platform for growth including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline. We are looking for an experienced QC Scientist to join our NJ team.    The QC Scientist will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial small molecule and biosimilar products in cGMP-compliant laboratories. 
ID
2021-2723
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 1 month ago(12/16/2021 1:14 PM)
Kashiv BioSciences is a fully integrated biosciences company with an expanded and dynamic platform for growth including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline. We are looking for an experienced QC Reviewer to join our Piscataway, NJ team. 
ID
2021-2722
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 1 month ago(12/16/2021 11:53 AM)
The successful candidate will be responsible for development and management of the Kashiv Piscataway stability program. The responsibility includes collaboration on development and execution of stability protocols and SOPs related to the stability program. The candidate will be expected to work with IT and Purchasing to validate and implement a stability software program. The position is responsible for all aspects of the stability program, including placing samples on stability, entering information into the scheduling database, pulling samples, scheduling testing, and ensuring testing is completed. An ability to conduct investigations and deviations and develop CAPAs and Change Controls is required. Stability chamber maintenance and management is a part of this role. Ability to collaborate across multiple departments to drive timely resolution of projects, investigations, and process improvements is required. The performance of general QC testing (release and stability) is also expected. The candidate will also be expected to ensure continuous coverage of the stability management function by selecting and training two individuals to be data verifiers of data entry and back up whenever absent.
ID
2021-2721
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 1 week ago(1/10/2022 4:17 PM)
Overview   We are the future!  Kashiv BioSciences is a fully integrated biosciences company with an expanded and dynamic platform for growth including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline.   We are looking for an Associate Scientist to join our Piscataway, NJ Upstream Manufacturing team. This function is responsible for the development and execution of cell culture processes for the manufacture of Kashiv assets. 
ID
2021-2719
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 1 week ago(1/10/2022 4:11 PM)
Overview   Kashiv BioSciences is a fully integrated biosciences company with an expanded and dynamic platform for growth including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline. We are looking for an experienced Microbiologist to join our Piscataway NJ Quality Management team.    This is an exciting opportunity to execute and work closely with Management on all aspects of Microbiology related to our pharmaceutical manufacturing site. 
ID
2021-2718
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 2 months ago(12/2/2021 9:14 AM)
Maintenance and Calibration Coordinator   The Maintenance and Calibration Coordinator is a regular employee in a full-time non-exempt position with the Engineering department at Kashiv BioSciences, LLC, in Piscataway, NJ. This position is responsible Maintenance, calibration and continuous improvement activities for Kashiv’s manufacturing, equipment, utilities and facilities to establish consistent production output while keeping down-time to a minimum and improving reliability over time.
ID
2021-2717
Company
Kashiv BioSciences LLC.
Job Locations US-IL-Chicago
Posted Date 2 months ago(12/1/2021 5:54 PM)
The successful candidate will be responsible for development and management of the Kashiv Chicago stability program. The responsibility includes collaboration on development and execution of stability protocols and SOPs related to the stability program. The candidate will be expected to work with IT and Purchasing to validate and implement a stability software program. The position is responsible for all aspects of the stability program, including placing samples on stability, entering information into the scheduling database, pulling samples, scheduling testing, and ensuring testing is completed. An ability to conduct investigations and deviations and develop CAPAs and Change Controls is required. Stability chamber maintenance and management is a part of this role. Ability to collaborate across multiple departments to drive timely resolution of projects, investigations, and process improvements is required. The performance of general QC testing (release and stability) is also expected. The candidate will also be expected to ensure continuous coverage of the stability management function by selecting and training two individuals to be data verifiers of data entry and back up whenever absent.
ID
2021-2716
Company
Kashiv BioSciences LLC.
Job Locations US-IL-Chicago
Posted Date 2 months ago(12/1/2021 5:47 PM)
The Validation Engineer is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This position will report directly to the Validation Manager and support various functional areas within Kashiv.
ID
2021-2715
Company
Kashiv BioSciences LLC.
Job Locations US-IL-Chicago
Posted Date 2 months ago(12/1/2021 5:36 PM)
Kashiv BioSciences is a fully integrated biosciences company with an expanded and dynamic platform for growth including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline. We are looking for an experienced QC Reviewer to join our Chicago team. 
ID
2021-2714
Company
Kashiv BioSciences LLC.
Job Locations US-IL-Chicago
Posted Date 2 months ago(12/1/2021 5:24 PM)
- The Manager, QA MQA, is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC, in Chicago, IL. The employee is responsible for supervising and managing the Manufacturing Quality Assurance function in the QA department. This role will oversee and direct the activities of the Manufacturing QA specialists. Works with the head of Quality Assurance to oversee and maintain CGMP compliant systems. Responsible for ensuring that manufacturing operations have appropriate QA oversight, including identification and management of nonconformances, investigations, and deviations. Provides QA support for on floor oversight of manufacturing, filling, and packaging activities. This position interacts primarily with Manufacturing and Engineering but has interface with all departments within Kashiv.  
ID
2021-2712
Company
Kashiv BioSciences LLC.
Job Locations US-IL-Chicago
Posted Date 2 months ago(12/1/2021 5:38 PM)
The Assistant I, Manufacturing is a regular employee in a full-time non-exempt position at Kashiv Biologics, LLC, in Chicago, IL, this employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. Employee employs aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning. Must comply with Kashiv BioSciences policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement.
ID
2021-2711
Company
Kashiv BioSciences LLC.
Job Locations US-IL-Chicago
Posted Date 2 months ago(11/29/2021 4:51 PM)
  The Microbiology Analyst III, Microbiology and Environmental Monitoring (EM) is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee is responsible for supporting the Microbiology and Environmental Monitoring (EM) department in implementing and managing the site’s microbiology and EM programs as well as the overall microbiology laboratory operations to ensure compliance with current regulations. This position requires direct interaction with the manufacturing processes related to biological non-sterile drug substance and sterile drug product. The employee’s qualification in aseptic gown is required.
ID
2021-2710
Company
Kashiv BioSciences LLC.
Job Locations US-IL-Chicago
Posted Date 2 months ago(11/29/2021 4:45 PM)
The Quality Control Analyst III will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial biosimilar products in cGMP-compliant laboratories and will also be expected to be engaged in continuous improvement initiatives to drive efficiency and effectiveness of Kashiv BioSciences Quality Systems. A strong background in protein chemistry will be essential to perform and troubleshoot techniques such as HPLC, UPLC techniques including RP-HPLC, SEC, HIC, IEX, and peptide mapping, SDS-PAGE, cell-based bioassays, capillary electrophoresis and standard compendial assays. A demonstrated ability to collaborate across multiple departments to drive timely resolution of projects, laboratory investigations, and process improvements is required.
ID
2021-2709
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 2 months ago(12/1/2021 11:08 AM)
Kashiv BioSciences is a fully integrated biosciences company with an expanded and dynamic platform for growth including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline. We are looking for an experienced QC Scientist to join our NJ team.    The QC Scientist II will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial small molecule and biosimilar products in cGMP-compliant laboratories. 
ID
2021-2707
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 1 week ago(1/10/2022 4:13 PM)
Overview   Kashiv BioSciences is a fully integrated biosciences company with an expanded and dynamic platform for growth including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline. We are looking for a Documentation Specialist to join our Piscataway NJ Quality Management team.    This is an exciting opportunity to work closely with Management on all aspects of Quality related to our pharmaceutical manufacturing site. Will work as a member of the Quality team to ensure GMP documents & quality standards.
ID
2021-2704
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 1 month ago(12/9/2021 6:01 PM)
At Kashiv Biosciences, LLC we unite caring with discovery to make life better for patients around the world.   Kashiv BioSciences is a fully integrated biosciences company with an expanded and dynamic platform for growth including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline. We are looking for an experienced Upstream Lead to join our Piscataway, NJ Manufacturing team.
ID
2021-2702
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 2 months ago(11/12/2021 2:32 PM)
We are the future.  Kashiv BioSciences is a fully-integrated biosciences company with an expanded and dynamic platform for growth including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline. We are looking for an experienced Downstream Scientist to join our Piscataway, NJ Manufacturing team.    The Downstream Manufacturing Scientist is a hands-on position responsible for executing purification of mammalian cell-based cultures and producing recombinant proteins for a wide range of mammalian based biosimilars. The candidate will be responsible in the purification of 50L to 1000L volumes engineering and clinical batches in a cGMP environment. This position requires technical expertise in AKTA purification skids or similar, TFF and knowledge of initiating batch records, protocols, investigations and other technical documents.   Work in a team environment to execute batches and can work independently with minimum supervision. This position requires extensive technical expertise in mammalian cell-based purification processes, cGMP manufacturing and compliance for BLA requirements.
ID
2021-2701
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 3 months ago(10/12/2021 4:31 PM)
Position Summary   A tremendous opportunity for Validation Engineers to join our Piscataway, NJ Engineering team.    Kashiv BioSciences is a fully integrated biosciences company with an expanded and dynamic platform for growth including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline.   The Validation Engineer provides support in performing equipment, facility and utility qualification activity to ensure compliance with cGMP, FDA guidelines and Kashiv quality requirements.
ID
2021-2690
Company
Kashiv BioSciences LLC.