MTSG Scientist I
Company: Sun Pharmaceutical Industries
Location: New Brunswick
Posted on: June 8, 2021
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
- 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
- Participate in manufacturing of scale-up and Submission
- Provides scientific and technical leadership in developing new
- Formulate and design drug products using QbD methodologies
- Assist in the transfer of site transfer and technology transfer
- 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
- 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
- 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
- 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
- Demonstrated excellent communication: verbal, written and
- A self-starter with a hands-on approach and a can-do
- 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
Didn't find what you're looking for? Search again!