Job Description

The Manager for the Analytical R&D Group fulfills a critical role in supporting the development group and the regulatory affairs department, by coordinating and monitoring successful qualification of vendors for API and excipients; development and validation of the analytical test methods and stability program for pharmaceutical dosage forms. This individual also leads and manages all analytical development documents including the specifications, methods, validation protocols, validation reports, equipment calibration and qualification reports and the reference standards. Also authors the CMC analytical documents for the ANDA submission for agency. Additionally, the analytical manager coordinates and participates in cGMP/regulatory pre-approval audits. This individual also trains and supervises the review group and evaluates them.

Essential Functions:

• Manages all R&D product analytical activities that are an essential part of the development for registration of products with FDA including coordination with AR&D group leaders to timely test, audit results and prepare and maintain database.

• Manages both electronic and copies for the analytical group documents including raw materials and product specifications, test methods, protocols, validation reports, laboratory equipment calibrations and qualifications records and reference standard qualification records.

• Writes eCTD documents such as Justification/Scientific Rationale, characterization and other documents such as SOPs, investigation and CAPA reports.

• Coordinates any document revisions when required for regulatory changes.

• Participates in coordinating FDA pre-approval and general audits.

• Serves as liaison between AR&D, Quality group and drug regulatory affairs.

• Provides technical and scientific support to RA in responding to CMC deficiencies.

• Stays abreast of new developments in analytical and compliance guidance from FDA/ICH and contributes to improvements in laboratory operations to increase efficiency and GMP compliance.

Additional Responsibilities:

• Other duties as assigned.

Education:

• Bachelors Degree (BA/BS) Pharmaceutical Science, Pharmacy or related field - Required

• Master Degree (MS/MA) Master of Science - Preferred

Experience:

• 8 years or more in Analytical Development Laboratory, Chemistry

• 5 years or more in Analytical Development Laboratory, Chemistry (with Masters)

Specialized Knowledge: Licenses: 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.