14 Drug Product Jobs

Role & responsibilities : Plan and execute preclinical formulation development of mAbs and ADCs to support programs during initial stage. Plan and execute pre-formulation studies, stability studies etc for mAB and ADC projects during early stages of pre-clinical development. Plan and execute formulation development of New biological entities from mAB and ADC platform for human clinical studies. Execute approaches and strategies for scale up, tech transfer of mAB and ADC drug products to manufacturing facilities. Coordination and execution of drug products of mAB and ADC under GMP set up for clinical trials with appropriate documentation. Support development of enabling formulations for impro...

Role Overview: As an Executive in the manufacturing department, your primary responsibility will be to supervise the manufacturing, processing, packaging, and holding of drug products according to approved procedures. You will also be in charge of maintaining the area and equipment in compliance with cGMP requirements. Additionally, you will be responsible for training subordinates on operational and cleaning procedures and coordinating IQ/OQ/PQ for new equipment/systems. Your role will involve following departmental SOPs for daily operations, handling material movement, and ensuring safety protocols are adhered to. Key Responsibilities: - Supervise manufacturing, processing, packaging, and ...

In this role as an Officer, your main responsibility will be to supervise the manufacturing, processing, packaging, and holding of drug products according to defined and approved procedures for stability batches and commercial batches. You will need to ensure that the area and equipment are maintained in an orderly manner as per cGMP requirements, in a good state of repair, and in a sanitized condition. It is essential for you to perform online documentation in adherence to departmental procedures and maintain good documentation practices. Additionally, you will be responsible for providing training on operation and cleaning-related SOPs to all subordinates and operators. Coordinating IQ / O...

You will be responsible for maintaining quality results, ensuring regulatory compliance, and improving existing systems to prevent non-conformance. This includes operating, calibrating, and maintaining various instruments such as HPLC, Dissolution, Analytical Balance, UV Spectrophotometer, Viscometer, GC, etc. You will also be required to record and maintain online entries in the instrument usage log book and follow good laboratory and documentation practices. Your responsibilities will also include performing analysis as per test request forms, following correct test procedures for analytical validations/verifications, routine analysis, and stability studies. Basic knowledge of method devel...

Role & responsibilities: The candidate should be an expert in the area of drug product development. He/she should have high level of experience to be called a subject matter expert in concepts of product stability, role of excipients in protein stability, knowledge of higher order structure and its role on product stability The candidate should be well-versed on drug product formulation development. He/she should have knowledge on the concepts of developing a brand new formulation, evaluation of buffer systems, sugar excipients, role of surfactants such as polyols etc. Having experience of developing new formulations for Biosimilar products is a plus The candidate should have experience in r...

Dear Candidates, We are looking for Pharmacist Assistant for our Hospital in Tirunelveli, People who are all interested, Kindly apply Now!!! For More Info Contact HR @ 6-384-40-5511 And share your resume at hr@porunaihospitals.com

As an R&D Executive at PTC - MORAIYA, your primary responsibility will be to perform analysis of Drug Product and Drug Substances for various test parameters according to the product development requirements. You will be involved in the method development of Drug Product and method verification of Raw Materials. Conducting literature searches for method development and impurity profile of drug products will also be a key part of your role. Additionally, you will be responsible for compiling analytical results and preparing Method Development Reports. Ensuring adherence to Good Laboratory Practices (GLP) in the analytical laboratory is crucial to maintain quality standards. Your contributions...

Vaccine Manufacturing (Cell Culture) Responsible for cell revival, subculture, cell counting of MRC-5 cells. Preparation of MCB/WCB. Experience in handling Roller bottles, Cell stacks, TCFs. Preparation of MCB/WCB. Experience in Preparation of media and in process buffers in media mixing vessels. Experience in handling Roller bottles, Cell stacks, TCFs. Experience in virus infection, virus harvesting procedures. Experience in working with Chicken embryo fibroblast cells, pooling of embryos, seeding of RB’s . Quality Control Analyst Biochemical techniques, Chromatography techniques, Electrophoresis techniques, Immuno assay techniques Cell culture techniques, Molecular techniques Analytical me...

You will be responsible for performing analyses of Drug Product and Drug Substances to evaluate various test parameters as per product development requirements. This includes Method Development of Drug Product and Method verification of Raw Materials. Additionally, you will compile analytical results and prepare Method Development Reports. It is essential to ensure adherence to GLP aspects in the analytical laboratory to maintain quality and accuracy in testing processes. The ideal candidate should have 0 to 3 years of experience in a similar role.,

The R&D Executive at PTC - MORAIYA will be responsible for performing analysis of Drug Product and Drug Substances for various test parameters according to product development requirements. This includes Method Development of Drug Product and Method verification of Raw Materials. The role also involves compiling analytical results and preparing Method Development Reports. Additionally, the R&D Executive will be responsible for ensuring Good Laboratory Practices (GLP) aspects in the analytical laboratory. The ideal candidate should have 0 - 3 years of experience in a similar role.,

Accountability Cluster Leading Drug Product activities SME of DP for biologics and biosimilars for Process Design, Quality management, and Manufacturing, Convincing experience in PFS operations SPOC for service providers and collaborators. Monitoring progress of the plan with high quality deliverables, provide technical expertise Providing technical support in device development for biosimilars Establish robust control strategy of process and its life cycle management Process Characterization and Process Validation Designing and execution of Process characterization studies Overseeing Process Validation studies with manufacturing support Managing the Product Life cycle management and Drive t...

Roles and Responsibilities Develop new products by leading cross-functional teams through formulation development, process development, and scale-up. Collaborate with external partners (CROs) on OSD product development and registration dossiers preparation. Ensure compliance with regulatory requirements for solid oral products at CDSCO and DCGI. Manage budgets, resources, and timelines for R&D projects to achieve business objectives. Desired Candidate Profile 15-18 years of experience in pharmaceutical industry with expertise in AR&D. Bachelor's degree in Pharmacy (B.Pharma) followed by Master's degree (M.Pharma). Strong understanding of formulation development, formulation research, Nutrace...

Roles and Responsibilities Develop and implement new product ideas through CDSCO process. Oversee research and development projects from concept to commercialization. Collaborate with cross-functional teams to ensure successful project delivery. Ensure compliance with regulatory requirements (DCgi) and maintain high standards of quality control. Desired Candidate Profile 15-18 years of experience in pharmaceutical industry, preferably in FR&D or similar role. B.Pharma degree in Any Specialization; M.Pharma preferred but not mandatory. Strong understanding of formulation development, formulations, nutraceuticals, OSDs, and solid orals.

Strategic: Representative for QMS activities in Drug product/ Drug substance area. Timely initiation and closure of QMS elements. Documentation related to Drug product/ Drug substance area. Training need identification for all the employees Assist the validations and routine validations of equipment and facility. Identify and implement the manufacturing and warehouse procedures with compliance to current GMP requirements. Coordination during customer and vendor audits. Coordinating with engineering and validation department for calibration and preventive maintenance. Coordination and implementation of software based QMS solutions like Track-wise, LMS, SAP etc. Operational: Initiation of chan...