The Externalization component of the client’s Early Formulation and Externalization department supports external development services within Pharmaceutical Sciences. The key focus of this role is to support projects that involve GMP clinical drug product manufacture. Projects may include non-sterile solid oral dosage forms (tablets, capsules), sterile products (vials), or specialty dosage forms.
Position responsibilities include but are not limited to:
Project management and execution oversight for drug product manufacture at external partners
Creation and management of project plans
Coordination of logistics, especially material shipments to/from the partner
Review and approval of batch documentation, including batch records, protocols, and reports.
Collaborating effectively with functional areas and support functions, such as quality, logistics, and trade compliance, to facilitate project delivery.
Leveraging relationships and networks to improve and enhance team dynamics; proactively identifying and removing obstacles to drive business results.
Maintaining accurate project data in SharePoint databases.
Preparing for, facilitating, and documenting outcomes of team meetings, ensuring meetings have clear purpose and objectives and that conflict is surfaced and resolved.
Execution of orders and transactions within electronic inventory management and tracking systems.
The ideal candidate would possess:
Bachelor’s degree: concentration in a scientific or engineering discipline
Two to five (2-5) years of experience in project management or drug product development/manufacture
Knowledge of current Good Manufacturing Practices
Demonstrated leadership and ethics; demonstrated ability to hold others accountable for delivery
Demonstrated ability to work effectively in a team setting
Strong collaboration and problem-solving skills; able to establish good working relationships with employees at all levels, resolve conflict, and to devise and implement creative solutions to problems
Strong communication skills, both oral and written; demonstrated ability to speak up appropriately and to raise issues to teams and management
Experience with Enterprise software
Experience with pharmaceutical manufacturing preferred