R&D Scientist

Job Overview

This is an R&D role in generic pharmaceutical product development. This role is very hands-on. The ideal candidate should have some experience in development to large scale submission batch manufacture.


This is a temporary position.

Responsibilities

R&D Scientist with previous industrial experience developing and filing generic drug dosage forms (orals/liquids)
Ability to develop the product using FBD, Compression and Encapsulation
Thorough understanding of the ANDA (and preferably NDA) filing process in line with QbD elements in generic product development
Experience working with projects from bench-top stage to large scale manufacture of submission batches.
Technology Transfer of ANDA Products under Manufacturing of Site Transfer Exhibit Batches for filing
Manufacturing and Packaging of Process Validation batches under
Support production in trouble shooting.
Preparation of Manufacturing Batch Records, Packaging Batch Records for Exhibit Batches, Commercial Batches and related documentation.
Manufacturing of Exhibit batches for ANDA Submission.
Preparation of qualification protocols and Process validation protocols, Summary and Process validation reports.
Preparation of Documents for Regulatory Submissions.
Review of Analytical Data/stability data.
Handling of Equipment like High Shear Granulator, Fluid Bed Drier, GPCG, Blender, Compression Machine and Coating Machine etc.
Perform other related duties as required and/or assigned.

Qualifications - Skills & Requirements

Knowledge of pharmaceutics, pharmacokinetics and process scale-up
Understanding of the ANDA (and preferably NDA) filing process in line with QbD elements in generic product development
Ability to work and collaborate in a team environment
Excellent spoken and written communication skills
Other Functions and Responsibilities (Other duties listed in this section are "not" essential or intrinsic to the job but are performed at times.

Education & Experience

Bachelor's or Master's degree in Pharmaceutics or a related field
Experience in formulation development and process development is preferred
Experience in the generic drug industry with ANDA filing and/or working with DEA controlled drug substances and relevant regulations is a plus


Physical Requirements

OFFICE POSITION - While performing the duties of this job the employee is required to: Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment Specific vision abilities required by this job include close vision requirements due to computer work Light to moderate lifting is required Moderate noise (i.e. business office with computers, phone, and printers, light traffic). Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

This is a temporary position.