 Amneal is a global essential medicines company powered by a robust U.S. generics business. Amneal is a growing branded business with deepening portfolios in institutional injectables, biosimilars and select international markets including India. Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is a global pharmaceutical company. Our team of 7,500+ colleagues helps make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of 270+ high-quality medicines.
Multiple Opening in R&D Injectable
Analytical Development Injectable | Method Development
Experience : 03 – 07 Years
Designation : Executive / Senior Executive
Job Description :
Method development like Related compound, Assay, Dissolution and Residual solvents etc. for development projects using instruments like HPLC, IC, GC, Particle size analyzer etc.
Prepare method development report along with tentative analytical method.
Attain method transfer activity & Preparation TT report
Method validation like Dissolution, Assay, Related compound and Residual solvents etc.
To keep neat and cleanliness at workplace and follow the Good Laboratory Practices in the Laboratory.
Preparation of study protocols with respect to Laboratory.
Development batch stability analysis as per stability protocols
Responsible for COA preparation and release of development sample against TRF.
Formulation & Development – Injectable | Product Development | USA / EU & Domestic Market
Experience : 04 – 10 Years
Designation : Senior Executive / Assistant Manager
Job Description :
Understanding of product development related activities of all injectable dosage forms for regulated market.
Exposure to injectable dosage form including exposure in development, scale up and execution of 505 (B2) injectable products, Emulsion, Colloidal solution etc.
Experienced in preparation and review of product development report, MFR, stability protocol, other study protocols, SOP etc.
Basic understanding of implementation of QbD principles for formulation development (QTTP, CQA, CPP, CMA, Risk assessment and Control strategy etc.)
Exposure of various QMS documents like change control, planned deviation, unplanned deviation etc.
Basic understanding of API specification, DMF, Excipients specification, In-process specification, Finished product & Shelf life specification of injectable products.
Basic understanding of preparation and review of necessary documents required for ANDA submission and approval of products.
Technology Transfer – Formulation & Development | Injectable
Experience – 03 – 07 Years
Designation – Senior Officer / Executive / Senior Executive
Job Description :
Responsible for Preparation of Master BMR, BPRs and document management.
Responsible for coordination with various departments like Regulatory Affairs, Manufacturing, Warehouse, Quality Assurance, Quality Control, Engineering for execution of Scale-up and Exhibit batches.
Responsible for reviewing GMP related documents.
To facilitate the Change Controls to be logged for various reasons. To initiate the Change Controls due to revision in BMR / BPRs and other PD related changes.
To study critical parameters during scale up batches to optimize the CPPs and CQAs.
To provide the input related to batch size, process feasibility & process parameters to formulation scientist as per requirement.
To monitor and ensure readiness for execution of scale-up / feasibility batches, Exhibit batches with respect to RM, PM & Miscellaneous items.
Responsible for reviewing GMP related documents as applicable.
Activities other than the defined in the Job responsibility are to be done, as per the requirement of HOD, by following HOD’s instruction and guidance.
To get actively involve in Scale-up and Exhibit batches.
Development QA – Research & Development | Injectable
Experience – 03 – 07 Years
Designation – Senior Officer / Executive / Senior Executive
Job Description :
Preparation of SOPs and to conduct the Sop Training.
Induction and Training of new employee and exist procedure completion of employee.
Coordination with plants and distribution of documents and retrieval documents.
Receiving, issuance and management of RLD’s.
To review and approve Stability study protocols and charging and withdrawal of stability samples.
To Review R&D documents
Interested candidate can share their updated cv at kavitriy@amneal.com
Last Date : 20th September 2024
