Multiple Opening in R&D Injectable at Amneal Pharma

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