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Job Locations US-NJ-Bridgewater
Posted Date 1 day ago(3/30/2020 2:43 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 Sr. Biochemist to join our Bridgewater, NJ Quality Control team.    The Senior Scientist / Biochemist 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 protein chemistry will be essential to perform and troubleshoot techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, 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
2020-2443
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Bridgewater
Posted Date 4 days ago(3/27/2020 1:50 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
2020-2441
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Bridgewater
Posted Date 6 days ago(3/25/2020 2:43 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.   Associate Manager will be responsible for conducting market research to identify new product opportunities and competitive analysis on 505(b)(2) development candidates, and present key findings and recommendations to the Chief Business Officer and Senior Management. Will provide market planning support for early-stage products under development.
ID
2020-2440
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Bridgewater
Posted Date 6 days ago(3/25/2020 2:42 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
2020-2439
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Bridgewater
Posted Date 6 days ago(3/25/2020 2:43 PM)
The Regulatory Affairs Associate will be responsible for supporting the regulatory activities of Kashiv’s 505b (2) projects. The individual will work collaboratively and proactively with the regulatory team and across multiple functional areas to help develop the strategy, scope, and content of the regulatory submissions.
ID
2020-2438
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 6 days ago(3/25/2020 2:42 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
2020-2437
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 6 days ago(3/25/2020 2:42 PM)
The Cell Line Development Scientist will be responsible for generating high producing mammalian cell lines for recombinant protein production. These cell lines will be used for preclinical, clinical and commercial biosimilar manufacturing. The candidate will be responsible for the cell line development design and execution activities. The position will also be involved in upstream cell culture process development and other project-related activities. This position requires technical expertise in molecular biology, cell biology, understanding of regulatory requirement for manufacturing cell line and working knowledge in bioprocess development.
ID
2020-2436
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Bridgewater
Posted Date 2 weeks ago(3/19/2020 11:37 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 Senior Scientist to join our Bridgewater, NJ Quality Control team.    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
2020-2435
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Bridgewater
Posted Date 2 weeks ago(3/19/2020 11:27 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 Sr. Biochemist to join our Bridgewater, NJ Quality Control team.    The Senior Scientist / Biochemist 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 protein chemistry will be essential to perform and troubleshoot techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, 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
2020-2434
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Bridgewater
Posted Date 3 weeks ago(3/13/2020 4:39 PM)
Kashiv BioSciences LLC is seeking a qualified scientist to join our research and development team on a full-time basis in Bridgewater, NJ.   This exciting role involves providing technical expertise on a range of cross-functional projects, including solid state characterization and physico-chemical property characterization on drug substance and drug product to aid process development, formulation development and analytical method development. Experience with designing and conducting a variety of dissolution/flux experiments aimed at understanding drug dissolution properties and underlying mechanisms is a plus.   The successful candidate will be proactive, detail-oriented and inventive, with strong analytical and problem-solving skills, and good interpersonal and organizational skills.
ID
2020-2433
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Bridgewater
Posted Date 3 weeks ago(3/13/2020 4:23 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
2020-2430
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 2 weeks ago(3/19/2020 9:16 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 Upstream Bioprocess Development Lead to join our Piscataway, NJ process development team. Please visit http://kashivbiosciences.com/ for more information about Kashiv BioSciences.   Summary The Upstream Bioprocess Development Lead 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
2020-2429
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Bridgewater
Posted Date 3 weeks ago(3/13/2020 9:25 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 Sr Accountant to join our Bridgewater, NJ Finance team.  The Senior Accountant will apply principles of accounting to analyze and report past and present financial information and prepare financial reports.
ID
2020-2425
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Bridgewater
Posted Date 3 weeks ago(3/12/2020 2:01 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
2020-2424
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 3 weeks ago(3/9/2020 10:54 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 Microbiologist to join our Piscataway, NJ Quality Control team.    Microbiologist II reports to and takes direction from Sr. Manager, Quality Control.  This job requires that the Microbiologiest II maybe the Microbiologist Subject Matter Expert (SME) when Management is not available. Schedules microbiological testing, release of product and testing for validation protocols
ID
2020-2422
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Bridgewater
Posted Date 4 weeks ago(3/5/2020 1:52 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
2020-2420
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 4 weeks ago(3/5/2020 1:44 PM)
We are seeking a Scientist III-AR&D to be based out of our HQ in Piscataway, NJ. The Scientist III Biophysical Characterization will be responsible for phase specific analytical method development and sample testing required for structural and Biophysical characterization of biologics through various phases of biosimilar development. Additional responsibilities include support of method transfer to QC laboratories and liaising with CRO laboratories. Techniques employed include but are not limited to Chromatography, LC-MS and spectroscopic techniques. Experience with sequence elucidation of protein using LC-MS/MS is desired. The candidate must have experience authoring SOPs and technical reports. The successful candidate will be a highly motivated, well-organized, and detail-oriented scientist who can work effectively in a fast-paced and multi-disciplinary environment.  
ID
2020-2415
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 4 weeks ago(3/5/2020 1:44 PM)
Position Summary   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 a Principal Scientist / Sr. Scientist Bioassay to join our Piscataway, NJ.    The Principal Scientist / Senior Scientist Bioassay is a member of a cross-functional team of professionals contributing to and enabling cutting-edge science at Kashiv BioSciences.   The successful candidate will be responsible for phase specific analytical method development and sample testing required for functional characterization of biologics through various phases of biosimilar development. Additional responsibilities include support of method transfer to QC laboratories and liaising with CRO laboratories.    Techniques employed include but are not limited to cell-based assays, ELISA and SPR binding assays. Experience with flow-cytometry, BLI binding assays and other plate-based assays like qPCR, Residual ProA, HCP assays is a plus. The candidate must have experience authoring SOPs and technical reports.   
ID
2020-2413
Company
Kashiv BioSciences LLC.
Job Locations US-NJ-Piscataway
Posted Date 2 months ago(2/12/2020 4:10 PM)
We are seeking a Scientist III-AR&D to be based out of our HQ in Piscataway, NJ. The Scientist III Biophysical Characterization will be responsible for phase specific analytical method development and sample testing required for structural and Biophysical characterization of biologics through various phases of biosimilar development. Additional responsibilities include support of method transfer to QC laboratories and liaising with CRO laboratories. Techniques employed include but are not limited to Chromatography, LC-MS and spectroscopic techniques. Experience with sequence elucidation of protein using LC-MS/MS is desired. The candidate must have experience authoring SOPs and technical reports. The successful candidate will be a highly motivated, well-organized, and detail-oriented scientist who can work effectively in a fast-paced and multi-disciplinary environment.  
ID
2020-2404
Company
Kashiv BioSciences LLC.
Job Locations US-IL-Chicago
Posted Date 1 month ago(2/25/2020 12:38 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
2019-2345
Company
Kashiv BioSciences LLC.