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Sr. Director, Manufacturing Science and Technology
4 months ago
Our client is looking for an outstanding candidate for a critical position to lead their Manufacturing Science and Technology (MSAT) Organization in support of their growing client portfolio for genomic medicines. This role is responsible for leading and growing a team responsible for end-to-end technical support of GMP manufacturing of autologous/allogenic cell therapies, viral vectors, mRNA, and other modalities.
Candidates should have extensive experience with biologics manufacturing in a GMP setting, technology transfer, managing and mentoring staff, regulatory filings, supporting regulatory inspections, and working within highly matrixed cross-functional teams. In addition to building out the MSAT organization to establish GMP-enabling change management, comparability, and data management systems.
Here’s What You’ll Do:
- Manage and expand the Manufacturing Sciences and Technology (formerly Technical Operations) organization for client’s Waltham facility.
- Provide key technical leadership for pre-clinical, clinical, and commercial programs across all aspects of the product lifecycle including technology transfer, process fit, process design, and manufacturing support. Launch business process and structure for process data reviews in collaboration with internal and external stakeholders.
- Create and launch process monitoring/trending, process validation, and process performance qualification programs (PPQ). Support client and/or internal product PPQ activities and management for on market products.
- Ensure successful delivery of GMP material in partnership with Manufacturing, Supply Chain, Quality and supporting functions by providing technical oversight of manufacturing batch execution, deviation management, troubleshooting, and batch disposition.
- Support transfer of technical expertise and knowledge to the Manufacturing team through training, education, and support.
- Assist with the development and drafting study plans and protocols as required to support regulatory requirements, deviations response, and process changes.
- Partner with CMC Regulatory and SMEs to develop content for regulatory submissions (INDs, BLAs, DMFs etc.).
- Actively support internal and regulatory audits of Waltham facility.
- Provide technical leadership for the design, construction, commissioning, qualification, validation, and operation of manufacturing expansion initiatives.
Requirements:
- Minimum Bachelor’s Degree in Engineering, Science, or related field. Master’s or Ph.D strongly preferred.
- At least 15 years of experience in a Manufacturing, Technical Operations, or GMP environment supporting complex products. Experience in autologous gene or cell therapy a plus.
- Extensive experience in leading product/process support within a GMP setting leading investigations, technology transfer, process monitoring, process validation, and routine clinical/commercial support.
- Experience working within a contract manufacturing or client service organization strongly preferred.
- Demonstrated ability and strength in leading cross-functional teams within a matrixed organization.
