Analytical Specialist

We are seeking a highly skilled Analytical Specialist in to join our Research and Development team for Nasal and Inhalation Division for developing, validating the analytical methods and evaluation of sameness studies forNasal and Inhalation products.

You are responsible to

• Develop, validate, and transfer analytical methods for Nasal and Inhalation products, including spray characterization techniques (SP, PG, DSD) and inhalation-specific techniques (APSD, DDU, Pump Delivery) along with assay and impurity methods .
• Should be well versed with the planning and conducting experiments for the PoP BE/sameness studies
• Perform Drug Master File/Literature review, procure relevant materials, and stay updated with industry developments.
• Execute analytical activities as per defined procedures, document data.
• Conduct method validation studies and transfer validated methods to Quality Control (QC) department/
• Ensure proper maintenance, calibration, and operation of laboratory equipment in compliance with Good Laboratory Practices (GLP) standards.
• Maintain accurate documentation, organize work area, and adhere to Standard Operating Procedures (SOPs) to ensure compliance with internal and external auditing requirements.

Qualifications

Educational qualification:

Minimum work experience:

Skills & attributes:

Technical Skills

• Have work experience on Formulation Development and expertise in inhalation/injectable dosage form.
• Understanding on Abbreviated New Drug Application (ANDA) filing requirements.
• Strong understanding of regulatory guidelines and industry standards related to pharmaceutical product development and analysis.

BehavioralSkills

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work collaboratively with own team and cross-functional teams.