The Director of Manufacturing, reporting to Chief Operating Officer, will be responsible for overseeing all aspects of Synthego's Manufacturing operations at both small and large scale. The Director of Manufacturing will be a dynamic leader responsible for overseeing end-to-end manufacturing operations for RUO, IND enabling, and GMP product lines in a fast-paced, science-driven biotech environment. This role will shape and drive scalable and compliant manufacturing strategies, foster cross-functional alignment, and ensure operational excellence in delivering high-quality products to customers.
What You'll Do:
Manufacturing Operations
Provide visionary leadership to Manufacturing teams across RUO, IND enabling and GMP programs, aligning production strategy with company growth objectives and technical capabilities.
Oversee day-to-day operations across all manufacturing facilities, ensuring delivery of production goals in compliance with internal standards and regulatory requirements (FDA, ICH) as applicable to product grade.
Manage production scheduling, resource allocation, and capacity planning to meet demand forecasts and reduce bottlenecks.
Define key performance indicators (KPIs) to monitor and measure manufacturing performance
Support the development and improvement of order intake processes, order management/LIMS systems, and innovative customer communication protocols
Ensure inspection readiness of manufacturing facilities and support GMP inspections and audits, responding to findings and implementing corrective actions
Support troubleshooting and investigation of customer complaints and non-conformance/OOS/OOT events
Ensure proper onboarding and maintenance of manufacturing equipment and facilities
Ensure a strong culture of safety by partnering with EHS to maintain compliance with health, safety, and environmental regulations.
Collaboration & Partnership
Partner closely with MSAT, Commercial, Research & Development, Technical Operations, and Quality teams to ensure successful transfer, scale-up, and launch of new products and technologies, while maintaining full compliance with applicable quality and regulatory standards.
Collaborate with Supply Chain, Accounting, Finance, and Commercial teams to ensure financial transparency, accurate product costing, and clear visibility into product margins.
Proactively address customer concerns, analyze feedback and performance data, and implement corrective and preventive actions to enhance product quality, service levels, and overall customer satisfaction.
Team Development & Culture
Drive a culture of safety, quality, compliance, and continuous improvement.
Build and mentor a high-performing team of managers, supervisors, and operators
Champion employee development, engagement, and retention initiatives
Establish performance goals and lead succession planning within the manufacturing function.
Budget and Resource Management
Oversee and manage departmental budgets, resource allocation, and overall manufacturing operations to maximize efficiency and performance.
Maintain accurate and up-to-date Bills of Materials (BOMs) to ensure operational integrity and cost control.
Ensure accurate and timely reporting of production orders and related data within the ERP system.
Lead cost-of-goods (COGS) optimization initiatives and drive continuous improvement in manufacturing efficiency.
Contribute to strategic capital investment planning for facilities, equipment, and infrastructure to support long-term growth and operational excellence.
About You:
Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field; advanced degree (PhD/MBA) preferred.
10+ years of progressive leadership experience in biotech/pharma manufacturing with a strong mix of GMP and RUO operations.
Experience in Oligonucleotide manufacturing production process and associated technologies
Strong understanding of process control, high throughput manufacturing, and technology transfer processes
Proven track record in building and scaling manufacturing operations, including managing new product introductions.
Strong understanding of laboratory best practices, continuous improvement methodologies, and lean manufacturing principles, including 5S, Gemba, and Kaizen
Experience with Pharmaceutical (GMP) Good Manufacturing Practices ICH Q7, preferred and FDA regulations
Experience with formal quality management systems required; ISO 9001:2015, ICH Q10, preferred
Familiarity with Financial acumen and budget management skills.
Strong leadership, communication, and cross-functional collaboration skills.
Ability to adapt to changing business needs and market dynamics.
Company Perks & Benefits
Medical, Dental, and Vision Benefits
401k Program
Catered Meals on Tuesday and Thursday
Paid Parental Leave
Flexible Paid Time Off
Additional Information
Our Mission
Synthego® is a pioneering force in the biotechnology industry, dedicated to advancing the frontiers of CRISPR cell and gene therapies through cutting-edge CRISPR technology and expertise. Our mission is to provide unparalleled access to CRISPR solutions at scale, empowering applications from Discovery to Clinic. Driven by a visionary approach, we strive to accelerate the therapeutic development process with best-in-class CRISPR solutions, simplified licensing & expert guidance, driving the adoption and success of CRISPR-based therapies to benefit all patients.
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