Manager AR&D Scientific Affairs

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Job description

Description:

The Manager for the Analytical R&D Group fulfills a critical role in supporting the development group and the regulatory affairs department, to coordinate and monitor 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 participate in cGMP/ regulatory pre approval audits.

Essential Functions:

Manage all analytical activities to support formulation development for dissolution profile, Assay, Related compounds and other relevant tests, also support to process development department (step by step analysis of blends and finished formulations) to optimize the process for scaling up of the formulations in the production scale. Manage the activities related to drug compatibility study with Active ingredient, RLD (Innovator) evolution; Reverse engineering of drug dosage form, Stability study of drug products to meet ICH guideline (Q1). Manage the activity of Instruments qualification and calibration.
Responsible for Analytical R&D group and fulfill a critical role to support the formulation development group and the regulatory affairs department. Correspondence with the cross functional department like Regulatory affairs, FR&D and QA etc. Coordinate with documentation team whenever documents revision required for regulator changes. Coordinate the QA team for any investigation and CAPA required. Provide the technical and scientific support to RA for responding to CMC deficiencies. Participate for FDA pre-approval audit and other regulatory audits.
Planning of experiments towards analysis of raw materials, standard preparation, Intermediates formulations, finished products and stability sample of all kind of dosage forms. API and Excipients vendor selection and qualification. Manage analytical method transfer and technical support to Quality control department.
Review and approve of study protocol, all kind of laboratory reports, analytical method, specification, standard operating procedures, eCTD documents and other CMC documents for ANDA and other regulatory submission. Evaluate of primary data of experiments performed and prepares analytical report. Reviews of Standard Operating Procedures (SOPs).
Manage activities related to Method development and validation.
Provide the training to scientists and reviewers. Supervising and evaluating the analytical team and review team.

Additional Responsibilities:

Other duties as assigned.

Qualifications - External

Education:

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

Experience:

8 years or more in Analytical Development Laboratory, and Chemistry is required.