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Sr. Principal Manufacturing Systems Lead

Semma Therapeutics

Semma Therapeutics

This job is no longer accepting applications

See open jobs at Semma Therapeutics.
Multiple locations
Posted on Friday, February 2, 2024

Job Description

General Summary:

The Sr. Principal Manufacturing Systems Lead will be a key technical resource in ensuring the planning and delivery and support of computerized systems for lab and manufacturing business partners. The Business Engagement & Technology Senior Principal Analyst will partner with business leadership to deliver digitally integrated manufacturing and lab capabilities. The candidate should be experienced with automated manufacturing equipment, robotics, laboratory instrumentation and scientific software and be comfortable working directly with operators, analysts, engineers, and scientists in a highly dynamic and innovative pharmaceutical company. This role represents the highest hands-on level of support for commercial and custom-developed equipment as well as lifecycle ownership of validated computer related systems for data acquisition and analysis. Successful candidates will have the opportunity to contribute high impact and strategic activities in the manufacturing and lab technology landscape. Additionally, the incumbent will maintain reliable, secure and compliant systems that easily meet business needs by efficient delivery, maintenance and ongoing enhancements.

Key Duties and Responsibilities:

  • Become a trusted partner of the business leaders within their remit, understand their needs and vision, and deliver technology solutions to support and enable their goals and objectives.
  • Help refine and execute the technology strategy by leading implementation, integration and ongoing maintenance of technology solutions.
  • Implement configured/custom software and workflow solutions for process operations, data acquisition, sample management or lab analysis.
  • Work closely with DTE Compliance, Internal Audit, and Quality Assurance groups as needed to ensure compliance with all appropriate regulations and data integrity expectations, as well as DTE system lifecycle and change management requirements.
  • Work independently and as a team member to research, configure and diagnose equipment and system failures and triage with vendors as needed.
  • Support the technical integration of process equipment and benchtop analyzers with enterprise data systems.
  • Ensure that the design and implementation of the service is consistent and supportive of the Vertex security architecture, data integrity and data protection standards based on documented requirements and identified technical, compliance and business risks.
  • Ensure requirements, procedures and technical specifications are documented in the appropriate SLC deliverables and / or CMDB.
  • Participate in the computer system validation (CSV) planning and execution of the solutions, authoring and / or contributing to key CSV deliverables.
  • Participate in the assessment, approval, and implementation of changes according to Vertex change management processes and procedures.
  • Lead and coordinate the definition, documentation and testing of the application and data recovery plan.
  • Manage relationships with software vendors and service providers.
  • Develop / maintain a long-term life cycle plan for the ongoing maintenance and management of systems.
  • Engage as a key participant in the strategic business planning process for their business partners
  • Provide insights on how technology can improve business processes to enable operating efficiencies and support the achievement of business goals and objectives.
  • Articulate and maintain a technology strategy to support and advance the business' objective. This strategy should factor in an understanding of future directions of the business area, as well as changes in the technology landscape.
  • Develop and maintain a long term life cycle plan for the ongoing maintenance and management of systems.
  • Manage relationships with our strategic software vendors and service providers
  • Establish, track and report on project value drivers and financial impact

Knowledge and Skills:

  • Cross platform hardware and software design and support at an advanced academic, pharmaceutical, biotech, or other scientific laboratory / manufacturing environment.
  • Proven track record of implementing custom software and workflow solutions for process operations, data acquisition, sample management or lab analysis.
  • Demonstrated experience with computerized manufacturing equipment, benchtop instrument and lab controller software/hardware troubleshooting and data integration.
  • Working knowledge of administering and maintaining Microsoft operating systems, domains, databases as well as common browsers.
  • Experience with GxP validation of equipment and computer related systems used in pharmaceutical processes.
  • Experience in establishing controls to ensure GxP data integrity and the ability to guide use cases into best practices for raw data management and digital integration.
  • Experience in securely connecting and administering manufacturing and lab equipment leveraging network, domain and security infrastructure including endpoint protection, patching, policies, remote management, authentication, backup/recovery, imaging, archiving, firewall specification, certificate management, ITIL, etc.
  • Experience with networking, administering and troubleshooting the computer related system for manufacturing and lab automated equipment.
  • Experience with manufacturing and lab integrations to data historian, MES, LIMS, SDMS, ELN using serial, TCP/IP, OPC, XML, REST, SOAP, file shares, etc.
  • Self-motivated, results oriented contributor with a proven track record of on-time delivery and ability to manage own workload with minimal direction.
  • In-depth knowledge in the core disciplines of project management, business analysis, solution design, delivery, testing and service management
  • Significant experience in building productive partnerships with business stakeholders and influencing them to take action
  • In-depth and specialized understanding of the business, processes, and any appropriate regulatory environments
  • Results oriented with a proven track record of on-time project delivery for large, complex projects with global stakeholders
  • Exceptional written and verbal communication skills and ability to present in a clear and concise manner to all audiences
  • Exceptional analytical, quantitative, problem-solving, and prioritization skills, including the development of business cases/ value propositions
  • Substantial program/ project management, demand management, resource management and system life cycle expertise
  • Strong analytical and problem-solving abilities including development of business case / value propositions
  • Prior experience with running IT managed services or outsourced/ offshore teams
  • Superior MS Office skills, including MS Project & Visio, Excel and PowerPoint Experience

Education and Experience:

  • Bachelor's degree in technology discipline or equivalent
  • Typically requires 9 years relevant business systems in the Life Sciences industry, or the equivalent combination of education and experience

Preferred Education and Experience:

  • Hands on experience with automated manufacturing equipment and scientific software for instrument control and data analysis.
  • Experience in supporting manufacturing and quality lab data workflows.
  • Functional/Technical knowledge in manufacturing and testing of biotech and pharmaceutical products / medical devices.
  • Knowledge of discrete manufacturing systems, including robotics, visual inspection.
  • Experience with Linux based operating systems.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.

This job is no longer accepting applications

See open jobs at Semma Therapeutics.