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

Cresilon, Inc; New York (NY); On-site; USD 130,000 - 190,000; Full time

Job summary

Cresilon, Inc., a biotechnology company, seeks an R&D Process Engineering Manager to oversee the development and scale-up of hemostatic medical devices. The ideal candidate will have a strong background in chemical and polymer processing, regulatory compliance, and proven leadership experience in fast-paced settings. This role offers an opportunity to significantly impact life-saving technology in a diverse and inclusive workplace.

Benefits

Paid vacation

Sick leave

Holidays

Medical/dental/vision insurance

FSA

Life and disability insurance

Employee assistance program

MetroCard reimbursement

401(k) with match

Qualifications

• Minimum 5 years in process innovation, development, and manufacturing.
• At least 5 years of management experience in leading engineers and technicians.
• Expertise in regulatory requirements and process design.

Responsibilities

• Manage process engineering activities and ensure compliance with safety standards.
• Lead technology identification and support manufacturing with process improvements.
• Document all cGMP activities per regulatory standards.

Skills

Leadership

Organizational skills

Project management skills

Analytical skills

Problem-solving skills

Communication skills

Education

Bachelor’s degree in chemical, biomedical, materials engineering, or related field

MS or MBA preferred

Tools

Microsoft Project

Microsoft Office

CAD tools

Job description

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

Description:

The R&D Process Engineering Manager oversees process engineering in the development and scale-up of Cresilon's hemostatic devices. Responsibilities include process development, scale-up, tech transfers, validations, improvements, and implementation within Cresilon's facilities and at CDMOs. The role requires integration into existing engineering systems, ensuring compliance with regulatory standards, and may involve facility maintenance and design. The ideal candidate will have experience in chemical or polymer processing and biotech applications. This position reports to the Vice President of Technology.

Job Responsibilities:

1. Manage all process engineering activities including development, implementation, improvements, scale-ups, tech transfers, and validations.
2. Lead technology identification, scale-up, process characterization, and validation, ensuring successful transfer and implementation.
3. Provide technical leadership across industries such as biotech, medical devices, chemicals, textiles, and food processing.
4. Identify CDMO options to enhance organizational capabilities.
5. Support manufacturing with process improvements and troubleshooting to optimize production and facilities.
6. Ensure all projects comply with safety standards like OSHA and NFPA.
7. Contribute to strategic planning for future process and facility needs, including budget and resource management.
8. Maintain compliance with specifications, SOPs, and FDA regulations.
9. Work to improve product quality, yield, and cost efficiency, collaborating with internal teams and suppliers.
10. Apply LEAN and Six Sigma principles for continuous improvement.
11. Document all cGMP activities per company policies and regulatory standards.
12. Manage training, development, and performance of the manufacturing team.
13. Perform other duties as assigned.

Qualifications:

• Bachelor’s degree in chemical, biomedical, materials engineering, or related field.
• MS or MBA preferred.
• Minimum 5 years in process innovation, development, and manufacturing, preferably in chemical/polymer processes and cGMP environments.
• At least 5 years of management experience leading engineers, scientists, and technicians.
• Hands-on problem-solving skills with a sense of urgency and results-driven mindset.
• Expertise in process design, development, transfer, and regulatory requirements.
• Experience with chemical and polymer formulation and purification is preferred.
• Experience with aseptic formulation and syringe filling lines is preferred.
• Proven ability to manage vendors and service providers.
• Strong knowledge of medical device regulations (e.g., 21 CFR Part 820), cGMP, ISO 13485 preferred.

Skills:

• Ability to prioritize and execute in fast-paced settings.
• Leadership, organizational, and project management skills.
• Knowledge of schematic capture and CAD tools preferred.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Experience with project management tools like Microsoft Project and Office.
• Legal authorization to work in the U.S. required.

Additional Information:

Cresilon is an equal-opportunity employer committed to diversity and inclusion. We prohibit discrimination based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any protected characteristic. We base hiring decisions on qualifications, merit, and business needs.

• Salary: $130,000 - $190,000 annually, depending on experience and qualifications.
• Benefits include paid vacation, sick leave, holidays, medical/dental/vision insurance, FSA, life and disability insurance, employee assistance, MetroCard reimbursement, and 401(k) with match.