- Wada Manor Road, Village - Varale, Palghar, Maharashtra, India
With supervision as required, proficiently performs all assigned chemistry techniques. Demonstrates a good understanding of scientific principals and their cause and effect on scientific outcomes. Practice of GMP/GLP is routine. Once appropriately trained, this individual may be designated as a notebook reviewer. Authors and may review others protocols, reports, specifications and test methods. Presents results at team meetings with interpretation. Acts as a coach to junior staff.
- Proficiently performs all assigned laboratory techniques.
- Independently develops analytical methods on a variety of analytical techniques and instrumentation.
- Independently performs method validation by authoring protocols, reports and analytical methods and may review or critique others.
- Tutors and trains others on troubleshooting analytical methods and instrumentation.
- Routine practice of and compliance with GMP/GLP.
- Designated notebook reviewer.
- Generates, analyzes and presents scientific data at team meetings. Explains cause and effect relationships and may propose additional experiments to
- prove/disprove hypotheses. Has a general understanding of the depth and breadth of drug development and can contribute to the scientific discussion during project team meetings.
- Understand regulatory guidelines and can author protocols, reports and analytical test methods.
- Generate and analyze scientific data and handle OOS’s (Out of Specification) with little difficulty.
- Has a good understanding of different plant manufacturing processes and can plan bench studies that will translate into a manufacturing process while solving related compounding, solubility, etc. problems.
- B.S. and 5 - 7 years of drug development/tech transfer/manufacturing experience or M.S. or Ph.D. and 2 - 3 years of drug development experience. Preferred education background in Analytical Chemistry, Pharmaceutics or similar discipline, however, extensive experience with analytical chemistry may be substituted for education.
- Significant experience with the drug development process
- Self-driven and self-motivated
- Excellent communication skills
- Track record of responsibility for multiple development projects
- Strong analytical background
- Liquid formulation experience is desirable
- Product development experience in the pharmaceutical industry
- Ability to meet deadlines
- Authorization to work in the United States indefinitely without restriction or sponsorship