Principal Scientist

Overview: Serves as a key contributor to the development of new experimental approaches through the application of formulation principles and practices. Develops and optimizes new formulation and technology, and new experimental approaches. Supports the development and submission of published reports, regulatory filings and/or initiating patent applications.Responsibilities:
Designs Formulations-
Generates accurate, reliable data by following established procedures and practices to support product development.
Designs and interprets experiments with some input from others.
Records, tabulates, summarizes, interprets, reports and publishes results.
Maintains scientific currency.
Analyzes and defends scientific results from experiments.
Reviews patentsProvide assistance to senior staff for fulfillment of project commitments.
Oversee experiments and the manufacturing of pilot and submission batches-
Supervises the technicians in the formulation and submission batch activities of the assigned projects.
Writes batch records for experiments, pilot and submission batches.
Writes product development and technical documents-
Write or co-authors Product Development reportsWrite and review Master Batch Records with some input from others for clinical manufacturing.
Trains personnel on SOPs.
Trains others on, operates, maintains, and troubleshoots instruments/equipment/techniques.
Demonstrates ability to secure commitments for projects across the relevant functional area.
Effectively represents Product Development in project team(s).Job Requirements
Qualifications:
Bachelor’s in Pharmacy, Engineering, or science related field with 10+ years of related experience or combined education & experience; or
Master’s in Pharmaceutics, Engineering, or science related field with 7+years of related experience or combined education & experience; orPh.D in Pharmaceutics, Engineering, or science related field with 2+ years of experience + 2-4 years of supervisory experience.
Understands theory, principles, and practice of formulation discipline.
Must have mechanical aptitude and hands on experience on the processing equipment.
Prior experience in the pharmaceutical manufacturing is necessary.
Ability to understand patents and claims.
Must be able to speak, write in English language.
Must have technical and practical knowledge on pharmaceutical processes and manufacturing equipment.
Expertise in the designs of pharmaceutical formulation.
Computer literacy to input data from batches.
Must be able to work with peers of other departments in completing documents and assisting Regulatory Affairs in ANDA submissions.