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 improvement, and process implementations 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 drive for results, balancing creativity with implementation.
- Expertise in technical process design, development, implementation, and process technology transfer with a thorough understanding of regulatory requirements.
- Experience in chemical and polymer processes, including formulation and purification is strongly preferred.
- Experience with semisolid aseptic formulation and syringe filling lines is strongly preferred.
- Demonstrated experience managing third-party vendors and service providers.
- Strong knowledge of medical device regulations (e.g., 21 CFR Part 820), cGMP, and related standards (e.g., ISO 13485) is preferred.
- Demonstrated ability to execute priorities in a fast-paced environment, working under pressure with tight timelines, with the ability to maintain a sense of priorities focus, and urgency.
- Requires strong leadership, organizational and project management skills, a keen attention to detail and multi-tasking prowess.
- Working knowledge of industry-standard schematic capture and mechanical design CAD tools preferred
- Ability to identify and analyze complex technical problems and implement innovative solutions is required.
- Ability to extract key facts from complex information and present concise summaries to management.
- Knowledge of Lean Manufacturing principles and Six Sigma Black Belt certification is strongly preferred.
- Demonstrated ability to lead and inspire teams and develop and mentor individuals and allocate resources strategically and according to the portfolio priorities.
- Excellent written and verbal communication skills, good interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators) are required.
- Experience working under pressure with tight timelines with the ability to maintain a sense of priorities focus and urgency.
- Extensive experience with using project management and/or collaboration tools (e.g., Microsoft Project) is required. Strong working knowledge of Microsoft Office is required.
- Legal authorization to work in the United States is required.
Cresilon is an equal-opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.
Benefits
- Competitive annual base salary range of $130,000 - $190,000, depending upon job level and qualifications.
- Paid Vacation, Sick, & Holidays
- Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage
- Company Paid Life and Short-Term Disability Coverage
- Work/Life Employee Assistance Program
- Monthly MetroCard Reimbursement
- 401(k) & Roth Retirement Savings Plan with company match up to 5%