Executive / Senior Executive - Formulation Development | Injectable

2 - 6 years

0 Lacs

Posted:2 weeks ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

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 responding CMC query, prepare and review PDR and other necessary documents of parenteral products required for ANDA submission, prepare SOP and different study protocols for product development, and review GMP related documents as applicable. Qualifications: - Master's in pharmacy in Pharmaceutics with minimum 2 years of experience About Us: Amneal is an equal opportunity employer that values diversity and inclusion, believing in fostering a workplace free from discrimination based on caste, religion, gender, disability, or any other legally protected status. (Note: Additional details about the company have been included for context.) (Note: The information regarding the Human Resources team has been omitted as it is not directly related to the job role described.) 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 responding CMC query, prepare and review PDR and other necessary documents of parenteral products required for ANDA submission, prepare SOP and different study protocols for product development, and review GMP related documents as applicable. Qualifications: - Master's in pharmacy in Pharmaceutics with minimum 2 years of experience About Us: Amneal is an equal opportunity employer that values diversity and inclusion, believing in fostering a workplace free from discrimination based on caste, religion, gender, disability, or any other legally protected status. (Note: Additional details about the company have been included for context.) (Note: The information regarding the Human Resources team has been omitted as it is not directly related to the job role described.)

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Amneal Pharmaceuticals logo
Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey