Director, IT Manufacturing Systems

Location
Gaithersburg, MD, US
Posted
May 03, 2021
Ref
720287100
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

I. JOB SUMMARY
This role will have responsibility for technical leadership for implementing manufacturing solutions with the emphasis on an enterprise manufacturing execution system. Ownership for delivery includes all aspects of business process, information, solutions, and application integration (SAP, automation systems, and LIMS). Role is accountable for building the ME support model and center of excellence (COE) in partnership with the business owner to define, establish, and lead the COE to support manufacturing systems lifecycle management.

This role will be remote/ virtual.

II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Solutions Delivery and Support
• Deep experience in life sciences manufacturing processes and solutions.
• Manage IT project initiatives for new enterprise ME solution collaborating with the project partners in the development of project plans and management of the implementation. Partner with appropriate Emergent personnel to understand project concept and define scope, objectives, and approach. Provide input into resource planning, staffing needs, cost estimation, budget development and cost control.
• Ensure project deadlines and schedules are met; ensure project team members prioritize multiple tasks effectively, ensure all IT resourcing is assigned and performing per expectations, and drives team to obtain fiscally successful project.
• Oversee team members performing facilitation of requirements gathering and lead the design of high-level solutions while providing necessary business context into technical design discussions.
• Manage the delivery of detailed documentation of MES and user needs, including workflow, program functions, and steps required to develop or modify business applications.
• Drive team in development of end to end process, information, streamlined cross-application integration, and technology in all solutions delivery accountabilities. Inform and educate on best practices for capability enablement through information technology solutions.
• Lead as technical domain specialist and act as IT solution architecture to review deliverable documents with functional leads or project team to ensure business requirements are adequately reflected to achieve overall business outcomes and optimal technical implementation is achieved.
• Ensure team members follow the change management process and all new capabilities and enhancements are entered and tracked through the IT Change Advisory Board.
• Manage relationships with Service Providers/Vendors to ensure the effective execution of the projects and services including oversight of project scope, SLAs, and critical metrics.
• Design and build the IT team and partner with business SMEs to establish global standards in design and global support model for enhancements, releases, SLAs, and other key operational processes.
• Ensure the Master Data Governance policies, guidelines and day to day processes are established during project delivery to ensure support team can effectively and efficiently manage data.
• Manage the development of service, maintenance, and operating level agreements to enable end-to-end MES delivery and support.

Solutions/Technology Architecture
• Responsible for the development of process (level 3 and 4), information (transaction level and reporting), and solutions and technology architecture deliverables. Inclusive of cross-application design and integrations for sharing information and managing dependencies between solutions.
• Design, improve and implement robust and controlled business process solutions for ME to ensure effective integration with other business functions and applications and manage adherence to enterprise architecture and platform standards within IT.
• Accountable for the development and implementation of solutions that ensure information consistency, quality, and availability.
• Work with business and IT teams to define and deploy best in class, harmonized business process and integration improvements utilizing Life sciences best practices and solution standard design capabilities.

Strategy / Roadmap
• Collaborate with IT Business Partner, Site manufacturing and automation engineers to develop and execute the business roadmap for new or extended platforms and associated technologies in the ME space.
• Contribute to and execute the technology vision for the ME platforms and work with business partners and IT support team to propose enhancements to support business functions and let throughout solution portfolio lifecycle from new product definition to end of life.
• Enable Emergent's growth strategy by driving efficiency and agility in application development and platform management by leveraging software solution delivery best practices, minimizing customization, and assessing IT trends within the organization.
• Partner across IT delivery and support teams for cross-application integration design and enhancement related decisions

Innovation
• Develop, implement and influence Emergent's strategic objectives and collaborate on updating the long-term business application roadmap based on those objectives and in overall alignment to the IT Strategy.
• Keeping abreast of solutions and technology future state. Bring to the business innovative ways to leverage technology to achieve their business outcomes.

Coaching / Staff Management
• Lead career development and succession management efforts to ensure retention, motivation and engagement of current and future staff; coach and mentor employees' professional and technical development
• Provide an environment that allows and perpetuates empowerment by pushing decision making responsibility down to the lowest level within practical qualifications

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

Education and Experience
• Bachelor's degree from accredited college or university is required specializing in computer science, information systems, or an advanced scientific degree.
• 8+ years of leading MES global software implementation delivery and on-going support services groups.
• 5+ years of experience in leading business application delivery in a validated pharmaceutical manufacturing environment leveraging a variety of software capabilities and best practices.

Preferred Qualifications
• Expert knowledge in Computerized System Validation and Good Documentation Practices
• Knowledge of Quality Assurance/Compliance, 21 CFR Part 11 and other FDA regulations
• Implementation and support experience with Werum or other MES tools
• Solid understanding of concepts of and hands-on experience in MES systems architecture, installation, and version management
• Good understanding of RDBMS database and solutions, virtualization, and high availability for distributed systems
• Experience designing and implementing Incident, Problem Change, Version, Release, Configuration and Continuity management for critical manufacturing systems at scale
• Experience with MES Master Data Management and integrations with ERP and LIMS systems

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

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