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 1 week ago

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Senior Executive, General R&D | F&D Injectable Amneal Pharmaceuticals

5.0 - 9.0 years

0 Lacs

ahmedabad, gujarat

On-site

You should have a comprehensive understanding of product development activities for all injectable dosage forms meant for the regulated market. This includes working with complex injectable products like suspension-based formulations, liposomal formulations, and Polymer based products. Your responsibilities will also involve preparing and reviewing product development reports, MFR, stability protocols, study protocols, and SOPs. Additionally, you should have a basic grasp of implementing QbD principles for formulation and development, including QTPP, CQA, CPP, CMA, risk assessment, and control strategy. Effective coordination with various departments such as regulatory affairs, manufacturing...

Posted 2 months ago

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Team Member Process Development Dr reddys

3.0 - 5.0 years

3 - 5 Lacs

Hyderabad, Telangana, India

On-site

We are seeking a dynamic and experienced person in Process Development Plan and execute process optimization trials & to execute scale up/ confirmatory batch and to support pilot batch, exhibit batches by applying various engineering concepts during optimization and scale up. Roles & Responsibilities You will be responsible for providing critical inputs in process design, executing experiments, and collecting and interpreting data to facilitate smooth process scale-up and ensure effective process control. This role involves collaborating with cross-functional teams, utilizing Quality by Design (QbD) principles, and finalizing batch sizes and equipment trains for successful scale-up and techn...

Posted 2 months ago

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Principal Non - Clinical Biostatistician GlobalHunt

5.0 - 9.0 years

0 Lacs

hyderabad, telangana

On-site

You will be responsible for contributing to the reliability, scientific quality, and optimization of project support throughout the entire process from target identification to process development. This will involve performing statistical analyses of data generated in the laboratories using R and potentially other programming languages to generate statistical reports. Additionally, you will play a key role in the development and maintenance of statistical end-user tools. Your expertise will be utilized in representing statistics within various scientific or technology working groups and cross-functional initiatives. To excel in this role, you should possess a strong background in non-clinica...

Posted 3 months ago

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Dy.Manager Regulatory Affairs - Injectable( US / EU / Canada) , Thane Hector And Streak Consulting

8.0 - 10.0 years

14 - 16 Lacs

Thane

Work from Office

We are looking DM RA with leading pharma company in Thane. Experience in Injectable regulatory affairs pre approval & post approval experience is must. Regulatory Submissions New Project Assignment This role involves the assignment and management of new projects for regulatory submissions, playing a pivotal part in the preparation and timely submission of high-quality regulatory documents across the US, EU, UK, and Emerging Markets. The position demands a strong understanding of global regulatory requirements, excellent communication skills, and effective cross-functional collaboration to ensure successful outcomes. Educational Qualifications Bachelor’s or Master’s degree in Pharmacy, Chemis...

Posted 4 months ago

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