Manager Process Engineering R&D (Chemical Process & Medical Device)

Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at www.cresilon.com.

Description:

The Process Engineering Manager is responsible for overseeing all aspects of process engineering in the development and scale-up of Cresilon's hemostatic medical devices. This includes but is not limited to, directing all process development, process scale-up, tech transfers, process validations, process improvements, and process implementation with Cresilon's internal manufacturing facilities, and at CDMOs. Critical to the individual's success includes the successful harmonization into existing facility engineering systems, procedures, and practices to ensure the proper manufacturing environment, in compliance with all state, federal, and regulatory governing agencies. They will also have some involvement in facility maintenance operations and facilities design/renovation especially as it pertains to process implementation. The ideal candidate will have expereince in chemical or polymer materials processing and experience in biotechnological applications. This role reports directly to the Vice President of Technology.

Job Responsibilities:

• Oversee all process engineering activities including process development/implementation process improvements, process scale-ups, process technology transfers, and process validations.
• Play a lead role in technology identification, scale-up, and process characterization & validation, including successful process transfer and implementation.
• Act as a technical thought leader in process engineering, provide technical expertise and scientific leadership in leveraging process know-how across industries including biotech, medical device, chemical process, textile process and food processing.
• Lead efforts to identify CDMO options to enhance organizational capabilities.
• Support Manufacturing with process improvements and production challenges, including troubleshooting, root cause analysis, and data trending toward continued manufacturing process and facility improvements.
• Ensure all engineering projects, initiatives, and processes conform with the organization's established policies and objectives and iadhere to OSHA, NFPA, and other applicable safety codes.
• Contributes to strategic planning by evaluating and projecting future process and facility needs, including proposing options to achieve them.
• Analyze CDMO, facility needs, plans, and budgets for expenditures in collaboration with senior management. Support efforts Manage the approved capital and process implementation-related expense budget to ensure that all budgets and schedules are met.
• Ensure compliance with all applicable specifications, standard operating procedures (SOPs), and FDA regulations.
• Ensure that all budgets, schedules, and performance requirements are met.
• Improve product quality, yield, and overall cost, working closely with internal personnel and external suppliers.
• Apply LEAN and Six Sigma principles to manufacturing operations, with an emphasis on a culture of continuous improvement.
• Document all cGMP activities following company policies, procedures, and applicable regulatory standards.
• Ensure effective selection, training, development, and performance management of the manufacturing team to meet business needs.
• Other duties may be assigned as deemed necessary by management.

Requirements

• Bachelor’s degree in chemical engineering, biomedical engineering, materials engineering, or equivalent required.
• MS degree in a closely related technical field or MBA preferred.
• 5+ years of experience in process innovation, development and implementation to manufacturing environments is required. Preferred expertise is ideally in chemical/polymer processes and in controlled manufacturing environments (cGMP, aseptic, etc.).
• A minimum of 5 years of direct management experience is required, with the ability to manage engineers, scientists, and technicians and influence, motivate, and drive technical rigor.
• Hands-on, roll-up-your-sleeves approach with a high sense of urgency and dri