Investigator/Senior Investigator-Solids Formulation & Process Development
, Pennsylvania
September 23, 2017
Basic qualifications:
• PhD in Pharmaceutics, Chemical Engineering, or other related fields with a minimum of 3 yrs of industrial experience in drug product development.

Preferred qualifications:
• Expertise in developing phase appropriate formulations and manufacturing processes for small molecules.
• Expertise in developing oral solid dosage forms and/or injectable formulations is preferred.
• Experience in leading product development matrix team is preferred.
• Good understanding of physico-chemical properties and biopharmaceutics is desired.
• Experience in continuous processes is desired.
• Demonstrates networking skills through interactions across departments, divisions, and disciplines
• Familiar with cGMP and regulatory requirements for manufacturing operations and documentation.
• Good oral and written communication skills.

Member of a team responsible for enabling the progression of NCE's from candidate selection to product commercialization.
Lead matrix teams or a member of matrix teams supporting product development.
Progress drug product design & development aspects of projects, or area of speciality, utilising substantial experience and expertise as part of a Product Development &Supply technical matrix team and wider matrix teams.
Exercise professional judgement to determine the most appropriate course of action for a project,
Contributes to Drug Product Design & Development strategies.
Develop phase appropriate formulations to support clinical studies and ultimately commercialization.
Develop and optimize processes for the manufacture of drug products and participate in manufacturing of clinical supplies.
Design and execute DOE, scale up studies, and participate in technology transfer.
Prepare development reports and participate in preparing regulatory documents.
Propose and deliver innovative approaches to achieve project goals.
Provide correct interpretation of results and perform complex data management and analysis.


Contact information:

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