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Manager, ERP

1 month ago

Durham, United States HUMACYTE GLOBAL INC Full time
Job DescriptionJob Description

COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, AV access for hemodialysis, and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also has received an RMAT designation. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.

JOB SUMMARY: This position is principally responsible for overseeing all activities as they relate to the management and support of the Great Plains Enterprise Resource Planning (ERP), interfaces and associated systems. This includes the configuration, customization, security, data integrity and on-going support for all functional areas. As a strong partner with the business, this position understands the business challenges and opportunities and align systems to support those needs. They will lead the configuration and maintenance of value-added solutions to meet the defined requirements and reporting needs of the business. Additionally, this position is responsible and accountable for troubleshooting and problem resolution, management of system resources, internal user performance, support and maintenance of all system environments, as required. This position will collaborate with internal departments, vendor-based consultants, and service providers to coordinate and manage the design, development, implementation and on-going support of all assigned business applications.

ESSENTIAL FUNCTIONS:

  • Provide technical leadership to develop product roadmaps; assessing the suitability of products and providing direction to service and software vendors, and/or IT to ensure technical solutions meet current and future business and department objectives.
  • Investigate feature requests, clarify user requirements and objectives, understand software functionality, and recommend appropriate solutions that meet business requirements and resolve questions related to process changes impacting applications.
  • Proactively provide expert advice to the business in best use of all Enterprise systems modules and functionality to improve business effectiveness and efficiency through appropriate change management systems.
  • Manage ERP System and associated systems upgrades, patching and refreshes.
  • Collaboratively analyze business process issues and improvement opportunities and provide effective/ efficient solution recommendations to IT management and business stakeholders.
  • Document and assist users in defining business requirements, process maps and use cases.
  • Partner with various departments regarding proposed system related projects to develop an understanding of their business processes, assess end user needs and evaluate system related change requests.
  • Ensure changes are managed under change control as a representative on Change Control Boards to ensure system remains in a state of validation compliance in line with site and corporate documentation, as well as relevant standards and regulatory regulations.
  • Manage assigned projects and ensure changes conform to the company Policies, Standard Operating Procedures (SOPs), Work Instructions (WIs) and other documentation.
  • Develop user training materials and deliver end user training as required.
  • Fulfill ad-hoc business reporting needs and assist with interpretation of data.
  • Manage third party vendors to ensure uptime and performance of hosted systems.
  • Support data exchange activities with interfaced systems.
  • Understand data migration and data integration approaches and technologies.
  • Understand master data management methods and techniques to drive data quality and data standardization.
  • Investigate problems with Enterprise system modules, diagnose root causes and resolve issues.
  • Provide ongoing system support, make decisions that best resolves product related issues and appropriately escalate issues that require IT and/or business management involvement.
  • Develop and maintain documentation of applications, including process workflow diagrams, detailed business requirements and reports, etc.
  • Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
  • Understanding current metrics and defining Key Performance Indicators (KPIs) to support departmental and company objectives.
  • Support Audits and Periodic Review processes as required.
  • Adherence to Project timelines and budgets.
  • Be a Champion and advocate for your assigned systems with internal and external stakeholders.

EXPERIENCE & QUALIFICATIONS:

  • The Manager ERP/Inventory Management Systems with 4-6 year of experience in ERP systems with specific experience with Great Plains. Collaboration with teammates, excellent customer service, proactive problem resolution and negotiation skills are essential.
  • Responsibilities include senior-level support, ERP and associated systems optimization, vendor management and staying updated with industry trends.
  • A strong track record of supporting and managing ERP systems, specifically Great Plains.
  • Management of a technical support team and 3rd Party Vendors supporting an ERP system.
  • Experience working in a regulated environment (GxP/Life Sciences/Biotechnology).
  • Working knowledge with validated systems and working within the Computerized System SDLC within the Validation Framework.
  • Must be able to work independently, as well as, in a team oriented, collaborative environment.
  • Effectively manage multiple priorities simultaneously and adjust to shifts in priorities to align with business needs.
  • Troubleshoot to solve complex problems.
  • Excellent interpersonal, written and verbal communication skills to build and maintain positive relationships across the organization and with external vendors.
  • Working knowledge of CFR part 11 and data integrity requirements.
  • Ability to elicit cooperation and influence a wide variety of people across different business units.
  • Ability to communicate ideas in both technical and user-friendly language at various levels in the organization.
  • Ability to comprehend, interpret, and comply with company policies and procedures.
  • Hands-on experience with design to prototype process such as requirements generation, design reviews, implementation planning and validation of design.
  • Overtime/Weekend work may be required.
  • Project Management Experience or PMP Certification preferred.
  • SQL Coding experience preferred.
  • Experience generating system and/or custom reports and workflows for Great Plains ERP systems preferred.
  • Excellent organizational skills with strong analytical and quantitative background.
  • Must be self-motivated and directed, can think critically, as well as conduct effective presentations.

COMPENSATION & BENEFITS HIGHLIGHTS:

  • Stock Options
  • 401k Plan with 4% Match and no Vesting Schedule
  • Medical, Vision and Dental Plans
  • Company Paid Long Term/Short Term Disability
  • Company Paid Life Insurance
  • 23 Days Paid Time Off (PTO)
  • 10 Company Designated Holidays + 2 Floating Holidays
  • Paid Parental Leave Policies

** Please note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3rd party firms and/or agency recruiters. **

The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.