HEAD OF MANUFACTURING AND PROCESS DEVELOPMENT

Bio Usawa; Maine; On-site; USD 250,000 - 300,000; Full time

Job summary

Bio Usawa is seeking a Head of Manufacturing to lead CMC process development, manufacturing, and supply chain for drug substance, product, and packaging. The role directs strategies, schedules, procurement, and logistics from development to market, ensuring compliant materials and partnerships.

They will own outsourcing strategies and oversee logistics for clinical trials and commercial products within regulatory and cost constraints.

Qualifications

• PhD or equivalent in Life Sciences, Pharmacy, or Engineering required.
• 15+ years in process development, biologics manufacturing and supply chain operations.
• Experience with contract manufacturing organizations and international supply chain architectures.

Responsibilities

• Oversee design and scale-up of processes to meet market size and cost.
• Develop and implement methods and equipment for timely, cost-effective production.
• Ensure compliance with regulatory requirements across development and operations.
• Create production planning, materials management, and staffing processes.
• Lead and train teams to support operational growth and excellence.

Skills

Strategic leadership

Regulatory compliance

Process scale-up

Education

PhD or equivalent in Life Sciences, Pharmacy, or Engineering

Job description

Job Description

The Head of Manufacturing will be responsible for overseeing the overall CMC process development, manufacturing and supply chain of drug substance, drug product and packaged goods. He/she determines operational and technical strategies to ensure attainment of financial and strategic goals, translating strategy into tactics and resource requirements. In addition, he/she oversees the execution of manufacturing schedules and operations, procurement, and logistics, from early-stage product development to commercial supply. The head will also be responsible for outsourcing strategy and partnership management to ensure adequate and compliant materials and product. The head will have overall responsibility for the company’s logistics strategy and oversight of supply chain management activities to deliver products to clinical trials and/or market within defined regulatory, legal, quality and cost standards.

Job Description

The Head of Manufacturing will be responsible for overseeing the overall CMC process development, manufacturing and supply chain of drug substance, drug product and packaged goods. He/she determines operational and technical strategies to ensure attainment of financial and strategic goals, translating strategy into tactics and resource requirements. In addition, he/she oversees the execution of manufacturing schedules and operations, procurement, and logistics, from early-stage product development to commercial supply. The head will also be responsible for outsourcing strategy and partnership management to ensure adequate and compliant materials and product. The head will have overall responsibility for the company’s logistics strategy and oversight of supply chain management activities to deliver products to clinical trials and/or market within defined regulatory, legal, quality and cost standards.

Job Responsibilities

• Oversees the design and scale-up of processes to meet market size and cost requirements.
• Develops and implements process methods and equipment to assure products are in a timely and cost-effective manner to meet market projections.
• Ensures process development and operations comply with regulatory requirements.
• Develops business processes for production planning, raw materials management, and production staffing.
• Develop and execute hiring and training strategy to ensure operational growth and excellence

Qualifications

• PhD or equivalent in Life Sciences, Pharmacy, or Engineering and 15 years’ experience in process development, biologics manufacturing and supply chain operations.
• Have a minimum of 15 years of experience in manufacturing of critical care therapeutics, in a GMP/FDA regulated pharmaceutical company; have experience in supporting Phase-III programs.
• Have extensive experience in technical transfers, qualification, validation, trouble shooting, BLA’s, FDA inspections, process scale-up, and commercial operations support.
• Have experience with managing contract manufacturing organizations and be familiar with international supply chain architectures including vendor selection, qualification, and contracting; understand the inbound quality control for materials and components.