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 leading biotechnology company, seeks an R&D Process Engineering Manager to oversee process engineering for hemostatic devices. The ideal candidate will manage engineering activities, ensuring compliance and process improvements while leading a team of engineers. This role requires expertise in chemical or polymer processes within controlled environments and offers competitive compensation and benefits.

Benefits

Paid vacation

Medical, dental, vision insurance

401(k) with up to 5% match

Disability insurance

Employee assistance programs

Qualifications

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

Responsibilities

• Manage process engineering activities including development and implementation.
• Lead technology identification and scale-up efforts.
• Ensure compliance with SOPs and regulatory standards.

Skills

Problem-solving

Leadership

Organizational skills

Communication

Project management

Education

Bachelor’s in chemical, biomedical, materials engineering or equivalent

MS degree or MBA

Tools

Project management tools

Microsoft Office

Job description

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

Description:

The R&D Process Engineering Manager oversees process engineering for Cresilon's hemostatic devices, including process development, scale-up, tech transfers, validations, improvements, and implementation within Cresilon's facilities and at CDMOs. Success involves harmonizing processes with existing engineering systems to ensure compliant manufacturing environments. The role may also involve facility maintenance and design related to process implementation. The ideal candidate has experience in chemical or polymer processing and biotechnological applications. Reports to the Vice President of Technology.

Job Responsibilities:

• Manage process engineering activities: development, implementation, improvements, scale-ups, tech transfers, and validations.
• Lead technology identification, scale-up, and process validation efforts, including transfers and implementation.
• Provide technical leadership in process engineering, leveraging know-how across biotech, medical device, chemical, textile, and food industries.
• Identify CDMO options to enhance capabilities.
• Support manufacturing with process improvements, troubleshooting, root cause analysis, and data trending.
• Ensure projects adhere to policies, OSHA, NFPA, and regulatory standards.
• Contribute to strategic planning for future process and facility needs, proposing options.
• Analyze facility needs, budgets, and expenditures; manage related budgets and schedules.
• Ensure compliance with specifications, SOPs, FDA regulations.
• Meet budgets, schedules, and performance requirements.
• Improve product quality, yield, and costs through collaboration.
• Apply LEAN and Six Sigma principles for continuous improvement.
• Document cGMP activities per policies and standards.
• Manage training, development, and performance of manufacturing team.
• Perform other duties as assigned.

Minimum Qualifications:

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

Skills and Attributes:

• Ability to prioritize in fast-paced environments, with strong leadership and organizational skills.
• Technical problem-solving and innovative solution implementation.
• Effective communication, team leadership, and resource management.
• Proficiency with project management tools and Microsoft Office.
• Legal authorization to work in the U.S. required.

Equal Opportunity Statement:

Cresilon is an equal-opportunity employer committed to diversity and inclusion. Discrimination and harassment are prohibited. Employment decisions are based on qualifications, merit, and business needs.

Compensation & Benefits:

• Salary: $130,000 - $190,000 depending on experience and level.
• Paid vacation, sick leave, holidays.
• Medical, dental, vision, FSA, commuter benefits, disability insurance.
• Life and short-term disability insurance.
• Employee assistance programs, MetroCard reimbursement.
• 401(k) and Roth plans with up to 5% match.