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MTSG Scientist I

Company: Sun Pharmaceutical Industries
Location: New Brunswick
Posted on: June 8, 2021

Job Description:

Product development scientist is responsible to develop ANDA/NDA products with minimal supervision that meets the expected FDA standards and can be successfully filed with USFDA.

  • Conducts scientific literature search periodically on assigned projects.
  • Independently design experimental plans, executes the studies for routine development, scale-up/s and exhibit batches.
  • Analyzes data and performs root cause analysis in trouble shooting.
  • Participate in manufacturing of scale-up and Submission Batches.
  • Provides scientific and technical leadership in developing new products.
  • Formulate and design drug products using QbD methodologies
  • Assist in the transfer of site transfer and technology transfer projects.
  • Evaluate and help develop new platform technologies, suggest patentable, patent non-infringing and design around technologies for FTF and 505(b) (2) products as needed.
  • Prepare reports on project status, literature review, and technical issues and their resolution affecting the product development.
  • Prepare product development reports, process development report and other relevant documents as required for filing.
  • Understands timelines and demonstrates a sense of urgency in work and in responding to customers and colleagues.
  • Complete all required in-house and external training to keep current on regulatory and industry changes
  • Must be able to work in a cross-functional environment interacting with departments such as formulation, analytical, regulatory, biopharmaceutics, quality and project management

Qualifications

  • Bachelor degree required, master's degree is preferred. Area of study should be in Pharmacy/Chemical
  • Minimum of six (6) years of experience in product development/tech transfer/site transfer/Process development or manufacturing
  • Engineering /Biology/Bio-Chemistry.
  • Knowledge of CGMP's, FDA, DEA, and OSHA regulations.
  • Knowledge of pharmaceutical operations, including tableting, particle coating for controlled or targeted
  • release applications, encapsulation and fluid bed operation etc.
  • Demonstrated excellent communication: verbal, written and presentation skills.
  • A self-starter with a hands-on approach and a can-do attitude.
  • Excellent project management and problem solving skills.
  • The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global
  • CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR)

Keywords: Sun Pharmaceutical Industries, New Brunswick , MTSG Scientist I, Other , New Brunswick, New Jersey

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