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Job Locations US-NJ-Bridgewater
Posted Date 3 days ago(5/26/2020 1:22 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 Coordinator to join our Bridgewater, NJ QC Analytical team.    The candidate will initiate stability studies in the system as and when required; Enter stability specifications for products to be placed on stability for studies on new products; Manage distribution and pull of stability samples to and from designated stability storage conditions; Maintain daily temperature/humidity records as identified in logbooks for each stability room/chamber; Assemble weekly charts on chart recorders and remove weekly completed chart and store in a binder; Inform laboratory management when any stability room/chamber undergoes any excursion in temperature or humidity for investigation; Provide stability data summaries for Annual product Reviews and Annual reports as per schedules; Perform stability data trends and inform quality management where out-of-trend data is observed; and Provide monthly pull schedules to QC manager so that work load can be assessed.
ID
2020-2486
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 6 days ago(5/23/2020 6:46 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 Scientist to join our Piscatatway, NJ Manufacturing team.    The candidate will lead the cGMP manufacturing processes and technology transfer. Authors documents (SOPs) to support batch records. Prepares production systems, buffers and media for use in the production area. Maintains production batch records and tracks/orders materials as necessary from the storage warehouse. Trains new operators and revises SOPs as needed. Troubleshoots process changes as well as implements new production procedures. Shall maintain the highest safety standards and quality.
ID
2020-2485
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 6 days ago(5/23/2020 6:33 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 Mass Spec Scientist I / 11 to join our Piscataway, NJ Analytical R&D team.    The successful candidate will be responsible for development innovative analytical methods to test biological drug substances and drug products, the planning and execution of studies to support formulation development and manufacturing process development, analytical similarity studies, and release/stability testing using LC-MS-based detection.  The incumbent must have the experience working in authoring SOPs and technical reports suitable for review by health authorities and mentoring other scientists. The successful candidate will be a highly motivated, well-organized, detailed-orientated scientist with the ability to work effectively in a fast-paced and multi-disciplinary environment.  
ID
2020-2484
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Bridgewater
Posted Date 1 day ago(5/28/2020 4:48 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 QA Associate to join our Bridgewater, NJ Quality Management team. This position is a 6 month temporary position that comes with Medical, Dental, and Vision benefits.   This QA Associate will be responsible for supporting Kashiv BioSciences Quality Assurance management in reviewing, implementing and managing the quality system to ensure overall product and process quality. As an integral quality team member, this individual will provide assurance that all products and quality system processes in the facility are in compliance with cGMP requirements and company policies and procedures
ID
2020-2483
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Bridgewater
Posted Date 1 day ago(5/28/2020 4:48 PM)
The Senior Scientist I 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.  A strong background in chromatography will be essential to perform and troubleshoot techniques such as HPLC, UPLC, and GC, as well as 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
2020-2481
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Bridgewater
Posted Date 1 week ago(5/22/2020 4:51 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 Scientist I / II to join our Bridgewater, NJ Analytical team.    A Scientist I / II will be a key technical resource responsible for independently developing methods, generating reliable and interpreting data, using analytical instrument that include HPLC, UPLC, GC, UV/Vis, Mass spectrometer, dissolution apparatus and particle analyzer. The Scientist will be expected to develop a close working relationship with Technical personnel at all levels within the organization to provide technical support needed in meeting R&D milestones and goals.   A Scientist I / II is also responsible for designing experiments, writing method validation protocols, conducting method validation, and processing and interpreting the analytical data.
ID
2020-2480
Company
Kashiv BioSciences LLC.
Job Locations US-IL-Chicago
Posted Date 1 week ago(5/22/2020 4:48 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 Quality Control Analyst III / IV- HPLC to join our Chicago, IL quality team.  Please visit http://kashivbiosciences.com/ for more information about Kashiv BioSciences.     The Quality Control Analyst III / IV 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
2020-2479
Company
Kashiv BioSciences LLC.
Job Locations US-IL-Chicago
Posted Date 1 week ago(5/22/2020 4:47 PM)
Kashiv BioSciences is seeking a highly motivated leader to join our growing team as the Manager of for our Quality Control laboratories. The successful candidate will be responsible for overseeing in-process and release testing of biological drug product, including data review and release of test results.
ID
2020-2478
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Bridgewater
Posted Date 1 week ago(5/21/2020 2:21 PM)
The Regulatory Affairs Manager (RAM) will work closely with the Regulatory and Clinical Affairs department to plan and coordinate all activities from pre-submission to approval of products in Kashiv development portfolio including 505(j) and 505(b)(2) applications.  The Manager will work with product development teams to guide the development activities according to the regulatory requirements.  He/she will be responsible for providing operational leadership, for communicating the regulatory requirements to the team, authoring certain portions, and overseeing editing and publishing of final submissions to meet appropriate requirements.   The Regulatory Affairs Manager will also assist with the nonclinical and clinical studies, including design, review of protocols, site monitoring, and finalization of reports for submission. He/she will be responsible for collecting, reviewing and preparing documents for submission in timely fashion.   The Regulatory Affairs Manager will make sure that all product related activities occur according to state and federal guidelines. He/she will apply for all necessary approvals and marketing permits from the FDA as well as international regulatory offices, and track, obtain and renew any required permits and licenses. The Regulatory Affairs Manager will participate in the site quality activities review and approve necessary change controls to comply with regulatory compliance.   The Regulatory Affairs Manager will also help in setting up standard operating procedures pertaining to all aspects of regulatory activities including conduct and management of clinical studies, labeling and pharmacovigilance.  He/she will develop and maintain excellence in knowledge of worldwide regulatory procedures and requirements.  
ID
2020-2477
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 1 week ago(5/21/2020 2:19 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 Lead Upstream Scientist to join our Piscataway, NJ process development team.    Summary The Lead Upstream Scientist is a hands-on position responsible for running the daily operation of Kashiv’s cell line development and upstream process development functions. The lead is responsible for developing robust mammalian cell culture processes, producing a wide range of mammalian based biosimilar proteins, and generating stable, high producing cell lines. This position requires technical expertise in cell culture processes, bioreactor operations and cell biology. It also requires working knowledge of cell line development.
ID
2020-2476
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 1 week ago(5/21/2020 2:14 PM)
Kashiv BioSciences 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 Bioprocess Development Scientist to join our Piscataway, NJ process development team. Please visit http://kashivbiosciences.com/for more information about Kashiv BioSciences. Summary The Upstream Bioprocess Development Scientist is a hands-on position responsible for developing robust mammalian cell culture processes and producing recombinant proteins for a wide range of mammalian based biosimilars. The candidate will be responsible for executing cell culture experiments from 15 mL to 50 L volumes, upstream process characterization, and tech transfer to cGMP facilities. The position will also be involved in cell line development and other project-related activities. This position requires technical expertise in bioreactor operations and cell biology, an understanding of regulatory requirement for manufacturing cell lines, and working knowledge of bioprocess development.
ID
2020-2475
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Bridgewater
Posted Date 1 week ago(5/21/2020 2:10 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 Facilities Mechanic / Supervisor to join our Bridgewater, NJ Engineering/Facilities team.    Kashiv is looking for a hands-on Sr. Facilities Mechanic / Supervisor to supervise and coordinate the day-to-day maintenance and repair of buildings, grounds, and associated equipment. Oversee staff that installs, inspects, repairs, and maintains building systems, including mechanical, electrical, plumbing, HVAC, safety, and waste management.
ID
2020-2474
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Bridgewater
Posted Date 1 week ago(5/21/2020 11:38 AM)
  Kashiv BioSciences 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 Senior Director of Clinical Development & Regulatory Affairs to join our Bridgewater, NJ Regulatory team.    A Senior Director of Clinical Development & Regulatory Affairs should be an experienced  regulatory and clinical candidate to work on clinical development and regulatory strategies for our innovative 505(b)(2) programs. The Sr. Director is responsible for the direction, planning, creation, and execution of clinical programs and regulatory strategies for biologics and 505(b)(2) candidates across multiple therapeutic areas.  This includes leadership and supervision of clinical pharmacology, clinical research and operations, medical affairs, pharmacovigilance, and regulatory affairs in alignment with department, company, and commercial goals. - The candidate will be responsible for leading the development of clinical strategies from proof-of-concept and clinical pharmacology through Phase 3 studies, and protocol development with CROs and KOLs.  - The candidate will identify the key strategic regulatory needs for early through late stage programs including the oversight of preparation, review and evaluation of documents (PIND, IND, NDA) for submission to health care regulatory authorities. - This candidate will collaborate with multiple internal stakeholders to ensure that all programs are implemented in accordance with project team strategies and in compliance with global regulatory agencies, and that overall business strategies are translated to guarantee optimal time to market.
ID
2020-2473
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Bridgewater
Posted Date 1 month ago(4/17/2020 4:35 PM)
Position Summary   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 research and development Sr. Scientist I / II to join our Bridgewater, NJ.    A Sr. Scientist I / II will be a key technical resource responsible for independently developing methods, generating reliable and interpreting data, using analytical instrument that include HPLC, UPLC, GC, UV/Vis, Mass spectrometer, dissolution apparatus and particle analyzer. You will be expected to develop a close working relationship with Technical personnel at all levels within the organization to provide technical support needed in meeting R&D milestones and goals.  This position is also responsible for designing experiments, writing method validation protocols, conducting method validation, and processing and interpreting the analytical data.   A Sr. Scientist I / II will be a key technical resource responsible for independently developing methods, generating reliable and interpreting data, using analytical instrument that include HPLC, UPLC, GC, UV/Vis, Mass spectrometer, dissolution apparatus and particle analyzer. You will be expected to develop a close working relationship with Technical personnel at all levels within the organization to provide technical support needed in meeting R&D milestones and goals.   This position is also responsible for designing experiments, writing method validation protocols, conducting method validation, and processing and interpreting the analytical data.
ID
2020-2456
Company
Kashiv BioSciences LLC.
Job Locations US-IL-Chicago
Posted Date 1 month ago(4/17/2020 4:30 PM)
Kashiv BioSciences 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 Aseptic Manufacturing Supervisor to join our Chicago, IL manufacturing department.   Please visit http://kashivbiosciences.com/ for more information about Kashiv BioSciences.
ID
2020-2451
Company
Kashiv BioSciences LLC.