Job Description

The Specialist for Drug Product
Manufacturing will be responsible, with management support, for providing
oversight of quality activities associated with drug product manufacturing
processes to contract manufacturing organisations. The Specialist contributes
and guides completion of milestones associated with specific projects and supports
ongoing quality assurance responsibilities in support of: Contract
Manufacturing oversight and quality systems including Change Control,
Deviations, and CAPAs. Performs all responsibilities in accordance with company
policies, procedures, and federal regulations. The incumbent will be
responsible for supporting the company drug product manufacturing and assessing the
compliance of this program against best industry practice and current
regulatory expectations.