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

$130,000 - $190,000/Yr

Cresilon - New York, NY

Full-time - Mid Level

New York, NY

Miscellaneous Manufacturing

About the position

The Process Engineering Manager at Cresilon is responsible for overseeing all aspects of process engineering related to the development and scale-up of hemostatic medical devices. This role involves directing process development, scale-up, tech transfers, validations, and improvements while ensuring compliance with regulatory standards. The manager will harmonize engineering systems and practices within manufacturing facilities and contribute to facility maintenance and design. The ideal candidate will have a strong background in chemical or polymer materials processing and biotechnological applications.

Responsibilities

• Oversee all process engineering activities including process development, implementation, improvements, scale-ups, technology transfers, and validations.
• Lead technology identification, scale-up, and process characterization & validation, ensuring successful process transfer and implementation.
• Act as a technical thought leader in process engineering, providing expertise across various industries including biotech and medical devices.
• Identify CDMO options to enhance organizational capabilities.
• Support Manufacturing with process improvements and production challenges, including troubleshooting and root cause analysis.
• Ensure all engineering projects conform with established policies and adhere to safety codes.
• Contribute to strategic planning by evaluating future process and facility needs.
• Analyze CDMO and facility needs, plans, and budgets in collaboration with senior management.
• Manage the approved capital and process implementation-related expense budget.
• Ensure compliance with specifications, SOPs, and FDA regulations.
• Improve product quality, yield, and overall cost in collaboration with internal personnel and external suppliers.
• Apply LEAN and Six Sigma principles to manufacturing operations.
• Document all cGMP activities following company policies and regulatory standards.
• Ensure effective selection, training, development, and performance management of the manufacturing team.

Requirements

• Bachelor's degree in chemical engineering, biomedical engineering, materials engineering, or equivalent required.
• 5+ years of experience in process innovation, development, and implementation in manufacturing environments required.
• A minimum of 5 years of direct management experience is required.
• Hands-on approach with a high sense of urgency and drive for results.
• Expertise in technical process design, development, implementation, and process technology transfer.
• Experience in chemical and polymer processes, including formulation and purification is strongly preferred.
• Strong knowledge of medical device regulations (e.g., 21 CFR Part 820), cGMP, and related standards (e.g., ISO 13485) is preferred.
• Excellent written and verbal communication skills, good interpersonal and management skills.

Nice-to-haves

• MS degree in a closely related technical field or MBA preferred.
• Experience with semisolid aseptic formulation and syringe filling lines is strongly preferred.
• Knowledge of Lean Manufacturing principles and Six Sigma Black Belt certification is strongly preferred.
• Working knowledge of industry-standard schematic capture and mechanical design CAD tools preferred.
• Extensive experience with project management and/or collaboration tools (e.g., Microsoft Project) is required.

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%