Formulation Scientist II

Akorn, Inc

Job Description

We seek a Formulation Scientist II to join our expanding R&D team who will be responsible for developing the final product formulation, process procedures and packaging of semisolids, suspensions and solutions, lotions, nasal sprays, inhalations, sterile injectable and ophthalmic products etc.


• Literature searching and review, patent searching and interpretation, performing risk assessment for formulation/process development, conducting experimental design and execution of lab scale, pilot scale developmental batches to support the final formulation and processes.
• Evaluation and selection of active, inactive raw materials and packaging components for various products.
• Formulate laboratory test batches to support product development, regulatory submissions and analytical method validation program.
• The Scientist is also responsible for documentation of the product development history and final product specifications along with Analytical Development Scientist.
• Development of CPPs, QTTPs, CQAs, and scale up manufacturing processes.
• Preparation of various study protocols to conduct in-compatibility/ compatibility studies including product contact studies with container closure system(s).
• Perform technology transfer of developed processes and procedures to scale up activities.
• Participate in activities leading to Technical Transfer, process validation and commercial production troubleshooting.
• Clearly document all data generated and report all research work performed - includes creation and documentation of study and experimental protocol, development of experimental process, identification and corrections of developmental and manufacturing issues/problems/ observations and writing formulation development report (PDR) based on Quality by Design (QbD) guidelines.
• Prepare GMP documents for Exhibit Batches including technology transfer report.
• Prepare and update daily, monthly report and Drug Development Plan on experimental activities and results.

Job Requirements

 

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