Senior Executive Analytical RandD Injectable Development

Description

JOB DESCRIPTION

Analytical Development - Injectable / Complex Injectable

The position supports peptide and oligonucleotide drug substance (DS) and drug product (DP) development through the development, optimization, validation, transfer, and application of advanced analytical methods to evaluate critical quality attributes (CQAs). The role contributes to product development across sterile and non-sterile dosage forms by performing physicochemical, structural, purity, impurity, identity, potency, and performance-indicating analyses to ensure product quality, comparability, and alignment with regulatory and reference product expectations. The role involves designing and executing analytical studies for process development, formulation development, characterization, forced degradation, stability, compatibility, and batch evaluation, while establishing scientifically justified specifications. The position ensures laboratory readiness, equipment qualification, analytical data integrity, and compliance with cGMP and global regulatory expectations to support regulatory submissions. The role also supports analytical method transfer, technical investigations, commercial manufacturing troubleshooting, lifecycle management, and the application of advanced analytical and computational tools—including chromatography, mass spectrometry, spectroscopy, and biophysical characterization—to generate scientific insights, enable informed decision-making, and drive innovation in peptide and oligonucleotide development.

Key Enhancements Specific To Peptides And Oligonucleotides

• Includes structural characterization (sequence confirmation, molecular integrity).
• Emphasizes purity, potency, and impurity profiling (truncated sequences, deletion products, deamidation, oxidation, aggregates).
• Covers forced degradation, stability, and comparability studies.
• Mentions advanced analytical platforms such as LC-MS/MS, HRMS, ion-pair RP-HPLC, IEX, SEC, CE, UV, CD, and biophysical techniques.
• Incorporates regulatory compliance relevant to peptide/oligonucleotide products.
• Includes lifecycle management and commercial support, which are important for modern analytical development roles.
  
  

Additional Responsibilities

• Raise indents, prepare Capex, and manage laboratory inventory.
• Taking responsibility to give training to junior for on job training
• Attend technical workshop /seminar and explore new technique and technology at work place
  
  

Education

QUALIFICATIONS

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

Experience:

• 5 years or more in 5 - 8 Years
  
  

Specialized Knowledge: Licenses:

About Us

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

About The Team

The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key Roles That The Human Resources Team Performs

Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.

Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.

Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.

Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.

Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.

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