Director, Manufacturing

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