R&D Scientist

• Characterize injectable and solid oral dosage forms that have quality and performance characteristics similar to that of reference product.

• Develop simple injectable products.

• Injectable products include those that solutions, suspension, and emulsion in ampules, vials, prefilled syringes, cartridges, and infusion bags.

• Formulation development of generic injectables includes pre-formulation studies (physic-chemical properties, drug-excipient-component interactions, stress testing),

• Analyze API, in-process, and finished products from reference and test prototypes based on compendial requirement. For non-compendial methods, develop and pre-validate analytical methods. Establish quality attributes for release and stability testing.

• Review ASMF / DMF, compendia, and other technical literature to familiarizer and prepare for the task (or project).

• Analytical knowledge to either a late-stage Contract Development Organization or directly to a Contract Manufacturing Organization.

• Draft protocols, reports, standard operating procedures, and work instructions to ensure compliance with Good Documentation Practices.

Expertise, Knowledge & Professional Experience

• Master’s degree or higher in Pharmaceuticals or Analytical Chemistry with 5-8 years of hands on industry experience in independently developing, characterizing, and analyzing parenteral and solid oral dosage forms.

• Good understanding of analytical techniques utilizing titrimetry, chromatography (HPLC, GC, hyphenated techniques), spectroscopy (UV, IR, NIR), dissolution apparatus, microscopy, and other associated technology for pharmaceutical product testing.

• Strong understanding of chemistry principles and its applications.

• Well-versed with ICH, EMA and US FDA requirements related to development of parenteral and oral dosage forms..

Key Skills and Behaviors

• Result driven, innovative.

• Effective written and verbal communication style.

• Strong analytical skills, enabling and optimistic can-do spirit.

• A collaborative, trust-enabling working style and an enthusiasm for building partnerships among key stakeholders.

• Adaptability, flexibility, independence and willing to roll-up-sleeves and multi-task in order to thrive in a growing environment.