Executive / Senior Executive - Formulation Development | Injectable Amneal Pharmaceuticals

2.0 - 6.0 years

0 Lacs

ahmedabad, all india

On-site

You will be responsible for the development related activities of all Parenteral Products. This includes preparation and review of MFR for exhibit batch of Parenteral products, indenting the raw materials, RLD, Packaging Material, and other items required for product development and exhibit batches. You will also be in charge of preparing and reviewing study protocols required for exhibit batch of parenteral products, reviewing specifications like API, Excipients, In-process, finished product, Shelf life etc. of Parenteral products, and primary packaging material. Additionally, you will review BMR and BPR of Exhibit batch, support Regulatory affairs department for ANDA submission and respond...

Posted 2 weeks ago

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Asst Manager / Deputy Manager, Formulation & Development Injectable Amneal Pharmaceuticals

5.0 - 9.0 years

0 Lacs

ahmedabad, gujarat

On-site

Role Overview: You will be responsible for product development activities of all injectable dosage forms for regulated markets including General injectable, Onco, and Peptide products. You will need to have a good understanding of ANDA and 505b2 product filing, as well as exposure to a wide range of dosage forms such as liquid solution, lyophilized, and suspension. Your role will also involve understanding Drug device combination products and regulatory expectations. You will be experienced in preparing and reviewing product development reports, MFR, stability protocols, study protocols, SOPs, and have a basic understanding of implementing QbD principles for formulation development. Key Resp...

Posted 2 months ago

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Assistant Manager, Technical Procurement Amneal Pharmaceuticals

5.0 - 9.0 years

0 Lacs

ahmedabad, gujarat

On-site

As a Technical Support Specialist at Amneal Pharmaceuticals, you will be responsible for providing end-to-end coordination for all R&D projects in a variety of areas including product initiation, API sample evaluation, product development, ANDA submission, FDA queries, ANDA approval, and launch. Your role will involve collaborating with API suppliers and internal technical teams such as Analytical, Formulation, Regulatory, and QA/QC to address technical concerns, document issues, material quality, and meet requirements for ANDA submission and regulatory agency approvals. You will utilize your technical knowledge to conduct detailed reviews of API drug master files according to current US FDA...

Posted 3 months ago

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