Senior Executive / Assistant Manager, Inhalation CMC

Company : Amneal

Job Type : Full Time

Sanand, India

Job Description - Senior Executive / Assistant Manager, Inhalation CMC

Description

Description:

This role is responsible for supporting the development of drug substance and drug product by designing and executing suitable analytical methods to evaluate quality attributes across various dosage forms. The position contributes to product development by performing quantitative, qualitative, and performance-indicative tests to align product profiles with reference formulations. It involves planning and executing controlled research experiments on trial batches, evaluating exposure and stability studies, and recording scientific observations with precision. The role supports the setting of product specifications and performs analytical method validation to confirm that methods meet their intended purpose within defined specification ranges. It ensures the operation and compliance of the laboratory environment, including setup, configuration, installation, and maintenance of equipment, while maintaining data integrity for regulatory submissions. The position supports stability studies and coordinates multiple projects on a day-to-day basis to meet regulatory timelines. It also facilitates analytical method transfer to commercial sites and addresses troubleshooting activities related to commercial support. Additionally, the role contributes to computational and experimental chemistry-based research, conducting exploratory studies to build scientific knowledge and deliver new methodologies. It leverages experimental data to drive key decisions and shape the direction of the research program within a global pharmaceutical context.

Essential Functions:

Develop and execute analytical methods for drug substance and drug product to evaluate quality attributes across multiple dosage forms
To perform test of MDI DPI dosage forms like APSD, DDU, SP-PG, Particulate matter for drug products
Perform quantitative, qualitative, and performance-indicative tests including identification, assay, related impurities, and dissolution to match product profiles with reference formulations
Plan and set up controlled research experiments on trial batches and evaluate exposure and stability studies with accurate recording of observations
Establish product specifications in alignment with regulatory and pharmacopoeial requirements
Conduct analytical method validation to confirm the intended purpose of methods within defined specification ranges
Maintain laboratory compliance including setup, configuration, installation, and maintenance of equipment while ensuring data integrity of scientific datasets for regulatory submissions
Support stability studies for regulatory submissions and coordinate day-to-day prioritization of multiple concurrent projects
Facilitate analytical method transfer to commercial manufacturing sites and resolve troubleshooting issues related to commercial support
Contribute to computational and experimental chemistry-based research to build scientific knowledge and develop new methodologies and products

Additional Responsibilities:

Qualifications
Education:

B. Pharm B. Pharm - Required

Master Degree (MS/MA) M. Sc. - Preferred

Experience:

5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

Original job Senior Executive / Assistant Manager, Inhalation CMC posted on GrabJobs ©. To flag any issues with this job please use the Report Job button on GrabJobs.

Share Job

Get your Resume Reviewed for Free

Similar Senior Executive Assistant Manager Inhalation CMC Jobs in India

Get your Resume Reviewed for Free

Email address

Why are you reporting this job?

I think it’s a discriminatory or offensive

I think it’s fraudulent or a scam

I think it’s trying to sell something unrelated to the job / it’s asking for money

I think it contains incorrect or broken information

Other

All Job Ads are subject to GrabJobs’s Terms of Service. We allow users to flag postings that may be in violation of those terms. Job Ads may also be flagged by GrabJobs moderation team. However, no moderation system is perfect, and flagging a posting does not ensure that it will be removed.

Setup your job alert:

Frequency

By activating job alerts, I agree to GrabJobs Terms & Privacy Policy. I can unsubscribe to job alerts anytime. Skip

Senior Executive / Assistant Manager, Inhalation CMC

Job Description - Senior Executive / Assistant Manager, Inhalation CMC

Similar Senior Executive Assistant Manager Inhalation CMC Jobs in India

Mobile Apps