Position Summary:

Responsible for independent problem solving. Specialized in at least one discipline that is directly applicable to the job function. Execute components of a project. Focus on meeting deliverables.

Position Responsibilities:

• Develops, leads and supports a team responsible for downstream process development and manufacturing activities. Conceptualizes, proposes and executes the evaluation, development and implementation of new downstream technologies leading to process improvements and efficiency of operation. This entails set-up, operation, and associated analysis of purification processes including small to pilot scale purification, filtration, viral clearance studies, data entry, and data analysis for various scales (AKTA Avant and Process)
• Responsible for producing high quality documentation and client reports suitable for publication and regulatory requirements.
• Works toward developing a broad knowledge of state-of-the-art principles and theory; may provide technical leadership in the group, may serve as in-house advisor on key scientific discipline areas.
• Hands-on cGMP manufacturing and provide technical support for clinical manufacturing and product testing.
• May be called upon (as a development assignment) to be a project team leader of a development program that includes the following duties:
• Direction and administrative duties including the coordination of efforts of team members and across departments; Acting as spokesperson on development programs and interact positively and productively with clients; Advising management on program status
• Responsible for developing/maintaining a current understanding of cGMP and other regulatory requirements.
• Adheres to all safety requirements and assures that departmental employees comply with required safety procedures.
• Able to react to change productively and handle other essential tasks as assigned.

Minimum Requirements

B.S. degree and 9 years of related experience; M.S. and 7 years of related experience or Ph.D. and 2+ years related experience in a scientific discipline.