4 Pk Studies Jobs

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5.0 - 9.0 years

0 Lacs

karnataka

On-site

As a Scientist in Pharmaceutical Development, you will be responsible for planning and executing various tasks related to the development, scale up, and manufacturing of drug products for monoclonal antibodies (mAb), bi-specific, tri-specific antibodies, and Antibody Drug Conjugates (ADC) of New biological entities (NBE). Your key responsibilities will include: - Significant experience in development, scale up, and manufacturing of drug products for mAbs, ADCs, etc. - Experience in parenteral delivery systems development like Nanoparticulate delivery systems, Lipid based delivery systems. - Proficient in pre-formulation studies of mAbs and ADCs along with physiochemical & Solid-State charact...

Posted 1 day ago

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6.0 - 10.0 years

0 Lacs

karnataka

On-site

As a Biology expert, you will be responsible for the following key responsibilities: - Expertise in handling HPLC and LCMS, including troubleshooting techniques. - Proficiency in different extraction procedures and independent handling of bioanalysis for various matrices in PK and ADME studies. - Good understanding of various column chemistry and its application in method development. - Ensuring data integrity and maintaining good documentation practices, including recording data in LNB and completing studies as required. - Operating and maintaining laboratory equipment. - Ensuring all instruments are maintained in a calibrated status. - Managing consumables and chemicals necessary for the s...

Posted 1 week ago

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3.0 - 7.0 years

0 Lacs

ahmedabad, gujarat

On-site

You will be responsible for planning and coordinating the initiation of research study protocols. This includes establishing operating policies and procedures while ensuring adherence to pre-established work scope, study protocol, and regulatory requirements. Developing and maintaining recordkeeping systems and procedures will be a key part of your role. Additionally, you will coordinate multiple data collection efforts with various collaborating agencies or institutions. Your duties will also involve writing and editing reports and manuscripts, as well as maintaining financial records for in vivo studies. It is essential to have knowledge of various PK studies, Toxicology studies, efficacy ...

Posted 1 month ago

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2.0 - 7.0 years

4 - 6 Lacs

kolkata, mumbai, ahmedabad

Work from Office

Role & responsibilities Job Title Senior Site Manager - Clinical Operations Location Kolkata/Ahmedabad - Remote, Mumbai (Hybrid working) Job Description: To do all regulatory/ethics submission as per timelines and to ensure regulatory documents are available, complete and current. In coordination with the project manager and/or medical monitor, perform study site qualification visits. Also to participate in/conduct investigators meeting and site initiation visits. To identify, define, coordinate and conduct site study training. In coordination with the project manager, provide oversight of all study-related activities. To perform regular monitoring visits to site. Prepare, maintain and updat...

Posted 1 month ago

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