Current Opportunities

Director of Manufacturing Technology

The Director of Manufacturing Technology will develop and manage a group of scientists, engineers and specialists at the site necessary to support a new growth strategy for the site. The Director’s primary responsibility will be to provide technical leadership in support of the fermentation and purification processes at the site. Responsible to partner with other functions both this site and other sites including manufacturing, quality, engineering, facility operations and project management teams to ensure timely and successful completion of key business growth initiatives and ongoing product release.

Senior Manufacturing Engineer

Will be assisting in the transfer of processes and process improvements from process development to the production facility and from one production facility to another. As required, assists in the planning and execution of process validation activities. May be asked to support additional projects in Manufacturing Support & Process Validation group. Ensures cGMP compliance. Works with validation to support the start-up of new facilities and validation of existing facilities. Trends and analyzes production data. Troubleshoots issues in conjunction with the manufacturing staff. Will Communicates issues in a timely manner. Author’s technical reports that support technology transfers, deviation/adverse event reporting and process analysis/trending.

Principal Engineer, Manufacturing Tech Support

Areas of focus are downstream processing and purification activities. Write the required reports, protocols and regulatory documentation associated with the executed studies. Check and approve protocols and reports written by other groups. Write relevant portions of drug substance manufacturing and process validation sections of regulatory filings. Write technical reports supporting technology transfers, deviation/adverse event reporting and process analyses/trending. This responsibility is shared with the Process Sciences Group. Support the Manufacturing Process Sciences Group, the Statistics and Quantitative Sciences Group and the Clinical Manufacturing Group as required. Consult with other groups to troubleshoot manufacturing process problems. Ensures cGMP compliance. Plans and manages the execution of process validation studies, such as process consistency studies, performed for company’s products. Main areas of focus are purification and downstream processing activities.

Head of Supply Chain and Logistics

Responsible for the overall management of the product supply and distribution chains, which includes managing all functions relating to the manufacture, packaging, testing, import, receipt and distribution of products within portfolio and regulatory compliance obligations.

Executive level alliance management of production and distribution vendors; Assurance of supply vendor operational and regulatory compliance status, capability and contract compliance. Partnering with product vendors on product or site issues that may affect inventory status and working collaboratively to mitigate issue in order to main a robust supply chain and assure regulatory and contractual compliance. Develop, implement and manage business and technical process and procedures for traceability and accountability of product in distribution chain, product and verification of customer eligibility and reimbursement (340B) status; Lead identification, qualification and selection of distribution vendors, and developing relationship terms and critical operational process with and between production and distribution vendors and customers.