Associate Director/Manager, Analytical Development

Job Description
Department: Development and Manufacturing Operations

Reports To: Sr. Director

Key Responsibilities:

Lead and manage development, and validation activities of protein analytical assays to support clinical development and commercial of therapeutic biologics including vaccines.

Develop overall analytical, characterization an stability strategies for compounds under development and commercial products.

Manage and coordinate lot release and stability studies of bulk drug substance and drug product at CMO/CRO to meet project timeline.

Manage technical, scientific and GMP related issues.

Compile and review document to support regulatory filings.

Qualifications:

PhD in Biochemistry, Chemistry, Bio-analytical Chemistry, Molecular Biology.

Minimal 8 year of industrial experiences in protein assay development and validation to support development of biologics.

Detailed understanding of current GLP/GMP practices, safety and regulatory requirements.

Excellent written, inter-personal communications skills as well as the ability to function in a fast-paced, team oriented environment.

Ability to travel 30 -40% of time.

Company

Nuron Biotech

Job Code

State or Province

Pennsylvania

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