Manager/Senior Manager Manufacturing Process Engineering

Cresilon, Inc is a medical device company based out of Brooklyn, NY that focuses on bringing new technologies to the animal health industry that aim to solve problems associated with wound healing. We have created a hemostatic device that can instantly stop traumatic bleeding. Please refer to these associated links to learn more about Cresilon:

• Http://www.bloomberg.com/video/vetigel-the-band-aid-of-the-future-stops-bleeding-instantly-PaIvLxjcS66F5IWO1SsKtA.html
• Http://www.ted.com/talks/joe_landolina_this_gel_can_make_you_stop_bleeding_instantly?language=en

The Manufacturing Process Engineering Manager/Senior Manager is responsible for overseeing all aspects of process engineering for Cresilon including, but not limited to, directing all manufacturing process development, process improvement, process scale-up, tech transfers, process validations, process implementations including the harmonization into the facility engineering systems, procedures and practices to ensure proper manufacturing environment, in compliance with all state, federal and regulatory governing agencies. They will also have some involvement facility maintenance operations, facilities design/renovation, construction and repair management, especially as it pertains to process implementation. This role reports directly to the Vice President of Technology.
Job Responsibilities:

• Ensure compliance with all applicable specifications, standard operating procedures (SOPs), and FDA regulations.
• Analyze facility needs, plan and budget for expenditures in collaboration with senior management. Manage the approved capital and facilities related expense budget to ensure that all budgets and schedules are met.
• Act as a technical thought leader in process engineering, facilities engineering and equipment reliability, including providing technical expertise and scientific leadership in troubleshooting, root cause analysis and data trending toward continued manufacturing process and facility improvements.
• Other duties may be assigned as deemed necessary by management.
• Contributes to strategic planning by evaluating and projecting future process and facility needs and proposing options to achieve them.
• Oversee all facilities engineering modifications, including impact to all aseptic manufacturing facility infrastructure, HVAC/major mechanical equipment, electrical, plumbing, roofing, utilities, and other infrastructure systems.
• Oversee all process engineering activities including process development/implementation process improvements, process scale-ups, process technology transfers and process validations.
• Document all cGMP activities in accordance with company policies, procedures, and applicable regulatory standards.
• Ensure that all budgets, schedules, and performance requirements are met.
• Improve product quality and cost through interaction with both internal personnel and external suppliers.
• Lead the expansion of Cresilon’s manufacturing locations, including site selection, securing bids, managing contracts, oversight of all execution activities.
• Apply LEAN and Six Sigma principles to manufacturing operations, with an emphasis on a culture of continuous improvement.
• Manage projects and schedule and lead execution of regular facility shut-downs.
• Ensure effective selection, training, development, and performance management of the manufacturing team to meet business needs.
• Implement maintenance strategies to optimize buildings, mechanical equipment, and other utilities.
• Play a lead role in technology transfer, scale-up and process characterization & validation.
• Ensure all engineering projects, initiatives, and processes are in conformance with the organization's established policies and objectives as well as in adherence to OSHA, NFPA and other applicable safety codes.

Requirements

• 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.
• Bachelor’s degree in engineering or equivalent technical field required.
• A minimum of 5 years of direct management experience required, with the ability to manage engineers, scientists and technicians and influence, motivate and drive technical rigor.
• Legal authorization to work in the United States is required.
• Expertise in technical / process design, development, and process / technology transfer with a thorough understanding of regulatory requirements.
• Demonstrated experience managing third-party vendors and service providers.
• Ability to extract key facts from complex information and present concise summaries to management.
• Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results
• MS degree in Engineering or closely related technical field or MBA preferred.
• Strong knowledge of medical device regulations (e.g., 21 CFR Part 820), cGMP, and related standards (e.g., ISO 13485) is preferred.
• Experience with semisolid aseptic formulation and syringe filling lines is strongly preferred.
• 5+ years of manufacturing process development and implementation experience is required, ideally in an aseptic manufacturing.
• Experience working under pressure with tight timelines with the ability to maintain a sense of priorities focus and urgency.
• Strong project management and organizational skills, including attention to detail and multi-tasking skills.
• Knowledge of Lean Manufacturing principles and Six Sigma Black Belt certification strongly preferred.
• Ability to identify and analyze complex technical problems and implement innovative solutions is required.
• 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.
• Extensive experience with using project management and/or collaboration tools (e.g., Microsoft Project) required. Strong working knowledge of Microsoft Office is required.
• Demonstrated ability to lead and inspire teams and develop and mentor individuals and allocate resource strategically and according to the portfolio priorities.
• Working knowledge of industry-standard schematic capture and mechanical design CAD tools preferred
• Requires strong leadership and organizational skills including attention to detail and multi-tasking skills.

Benefits

• Medical, Dental, and Vision Insurance
• Competitive annual base salary range of $130,000 - $190,000, depending upon job level and qualifications.
• Company Paid Life and Short-Term Disability Coverage
• 401(k) Retirement Savings Plan with Company Match
• Paid Vacation and Holidays