Manager of Manufacturing Logistics - New Jersey (FullTime) (FullTime)

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The individual in this position is responsible for the management of clinical and commercial inventory supply chains. This will include negotiating process manufacturing agreements and amendments to manufacturing contracts; and, providing oversight to ongoing manufacture of bulk drug substance and final drug product. The individual will schedule manufacturing and track production at contract sites to all relevant internal groups. This position is designated as the primary liaison for contract fill/finish and/or bulk manufacturing site(s). The position is accountable for the communication of status/issues with contract manufacturing sites to all relevant groups. Cultivating relationships with internal groups (QA, QC, Regulatory, Process Sciences) will be at the core of issue resolution within the framework of the position. Additional responsibilities include the maintenance of all documentation to include minutes and reports associated with manufacturing sites as well as the processing of invoices and the tracking of budgets. The individual in this position will be called upon not only to provide leadership regarding implementation of new projects and technology transfer at contract sites, but to lead the evaluation of alternate manufacturing sites.

Qualifications

• Bachelors and/or Masters Degree in a scientific discipline
• 5-8 years experience in an industrial biotechnology manufacturing/quality/development environment
• In-depth understanding of antibody or biologics manufacturing and regulatory requirements, including cGMP’s is necessary.
• Knowledge of Quality issues as related to manufacturing of biologics is essential.
• Experience managing outside contractors in biological drug development is preferred.