Description
JOB DESCRIPTION
Department -R&D – Bioanalytical / DMPK
Experience Required - 5–8 Years
Educational Qualification
- M.Sc. / M.Pharm in Life Sciences, Pharmaceutical Sciences, Biotechnology, Pharmacology, Biochemistry, or related discipline
- Preference will be given to candidates with specialization in Pharmaceutical Analysis, Pharmacology, Bioanalysis, or related fields
Job Summary
We are seeking an experienced and highly motivated candidate for the Bioanalytical & DMPK department within R&D. The ideal candidate should possess strong hands-on expertise in LC-MS/MS based bioanalytical method development and validation for small molecules, peptides, and large molecules, along with exposure to GLP and non-GLP bioanalytical studies.
The candidate should also have working knowledge and practical exposure to in-vitro ADME studies and a good understanding of DMPK functions supporting drug discovery and development activities.
Key Responsibilities
Primary Responsibilities – Bioanalytical
- Perform LC-MS/MS based bioanalytical method development and validation for:
- Small molecules
- Peptides
- Large molecules / biologics
- Execute bioanalysis for GLP and non-GLP studies
- Develop, optimize, troubleshoot, and validate bioanalytical methods as per regulatory guidelines
- Perform sample preparation and quantitative bioanalysis using LC-MS/MS platforms
- Analyze pharmacokinetic and bioanalytical samples from preclinical studies
- Prepare method validation reports, study reports, SOPs, and technical documentation
- Ensure data integrity, compliance, and adherence to GLP/laboratory practices
- Troubleshoot analytical and instrumentation-related issues independently
Secondary Responsibilities – ADME / DMPK
- Conduct and support in-vitro ADME studies including:
- Metabolic stability
- Plasma protein binding
- CYP inhibition/induction assays
- Permeability assays
- Plasma stability and solubility studies
- Support DMPK screening activities for discovery and development programs
- Interpret ADME/DMPK data and provide scientific inputs to project teams
Required Skills & Expertise
- Strong hands-on experience with LC-MS/MS instrumentation and bioanalytical workflows
- Expertise in bioanalytical method development and validation
- Experience handling small molecules, peptides, and large molecule bioanalysis
- Knowledge of regulatory expectations for GLP and non-GLP studies
- Understanding of pharmacokinetics, bioanalysis, and DMPK concepts
- Exposure to in-vitro ADME assays preferred
- Strong scientific data interpretation and technical writing skills
- Good communication and cross-functional collaboration abilities
Preferred Candidate Profile
- Candidates from pharmaceutical, CRO, or drug discovery organizations preferred
- Ability to independently manage bioanalytical studies and laboratory activities
- Strong problem-solving and scientific reasoning skills
- Experience with regulated bioanalytical environments will be an added advantage
Education
QUALIFICATIONS
- B. Pharm B. Pharm - 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.
