Manager, Product Development Scientific Affairs job in Princeton
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
Under the direction of the Head of Scientific Affairs, the Manager Product Development, Scientific Affairs is responsible for supporting the Scientific Affairs Department in the technical evaluation and due diligence of technology platforms and pharmaceutical products (complex generics and products to be filed under 505b2 regulatory pathway) being considered for in-licensing|
as BD&L projects.
• Must have strong early phase development (pre-formulation) experience in parenteral dosage forms (especially Liposomes) with strong knowledge of physical pharmacy, physico-chemical characterization and polymer chemistry.
• Must have experience in the evaluation and/or development of technology formulation platforms.
• This role is expected to have significant interactions at cross-functional level and collaborates within and across functions with excellent communication skills.
• Deep critical thinker and proactive problem solver. This includes working directly with a cross-functional team across Business Development and Licensing (BD&L), Regulatory Affairs (RA), Quality Assurance (QA),Clinical Development (CD) and Manufacturing Science and Technology (MST) to evaluate CMC aspects of new product acquisition and in-license opportunities, using their own knowledge and experience.
The Manager, Scientific Affairs must be able to analyze operational activities of Research and Development activity for internal and BD&L projects to obtain a quantitative and rational basis of making a go forward decision.
• Must be able to demonstrate expertise within the framework of formulation development and regulatory requirements for product development and regulatory filings respectively
• Knowledge of current pharmaceutical technologies, including formulation of advanced and standard liquid and parenteral dosage forms (especially Liposomes)
• Experience in pre-formulation development and robust product development utilizing QbD principles.
• Experience in the preparation of regulatory submission documents
• Strong Knowledge of physical pharmacy and Physico-chemical characterization of various types of dosage forms, mainly injectable.
• Experience in the evaluation and/or development of technology formulation platforms.
• Knowledge of polymer chemistry and its application to dosage form development (Injectables) are a plus.
• Experience with development of formulations using synthetically produced peptides are a plus.
• Experience with statistics and Design of Experiments are a plus.
• Ability to develop product development plan for use as a guidance during the development of the target product
• Ability to present complex issues in oral and written form.
• Ability to work independently, take initiative, lead and complete tasks to deadlines.
• Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and working efficiently to meet deadlines.
• Strong team player and excellent communication skills to drive the projects.
• Problem solving: identifies technical problem with root cause
• Requires deep critical thinking skills and proactive problem solving skills• BA/BS required
• PhD or Masters' degree in Pharmaceutical Sciences or closely related field preferred
• At least 8 years' experience with Master's degree or at least 6 years' experience with PhD in early phase formulation development.
• Demonstrated experience in evaluation and/or development of technology
platforms is desired.
• Business development and due diligence experience is desired.