Information Systems Manager
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
By providing a foundation for all operations company wide, BioMarin’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.
The BioMarin Information Management Scientific Platforms (IM SP) department seeks a highly talented and motivated Information Systems Manager to lead a team supporting applications used in both the laboratory and manufacturing plant for monitoring and analyzing process performance. The successful candidate will have the opportunity to partner closely with both scientists, engineers and IT professionals within multiple departments and sites. She/he will play a key role in evaluating, designing, deploying and maintaining hardware and application systems. A strong candidate will have a successful track record implementing and maintaining laboratory information management systems (LIMS) and various laboratory analyzers. Experience with the pharmaceutical/ biopharmaceutical industries would be a plus.
The ideal candidate will work closely with various IT teams, analysts, users and vendors to assess requirements, design, procure and implement laboratory and manufacturing computer systems. Implementation and maintenance of these computer systems requires a strong emphasis on documentation and change control in accordance with maintaining systems in a regulated environment. While designing systems, the candidate would both research and recommend hardware, software and services by analyzing vendor proposals. Long term support of systems will require the candidate administer and maintain systems ensuring software and hardware are maintained at levels appropriate for critical manufacturing processes. Finally, the ideal candidate will possess expert knowledge in a variety of manufacturing applications, operating system, network architectures and database environments.
BioMarin is a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. Applicants must bring a high level of initiative, energy and motivation to the role and have excellent communication and organizational skills.
- Architect and deploy enterprise laboratory and manufacturing applications for internal customers with the support of contractor teams and/or BioMarin employees
- Lead individual contributors with various experience levels to provide solutions for multiple highly critical applications across multiple manufacturing sites in a FDA regulated biotech environment
- Additional responsibilities include contributing to on-going support of informatics applications with the overall goal keeping systems functional and usable by scientists (e.g., AWS, Dynamic Utilization of Cloud Computing Resources)
- Author System Development Lifecycle (SDLC) supporting documentation and tests (e.g., User Requirements, Technical Requirements, System Architecture, Design Specification, Application Configuration, Functional Requirements, User Acceptance Test)
- Identify, recommend and implement technical solutions for a variety of process analysis applications
- Research and test emerging technologies to improve delivery and efficiency in accordance with IT Enterprise Strategy; applicable to system architecture, data management and other similar areas
- Ensure all tracks of project implementation occurs in accordance with established change control procedures
- Apply knowledge and experience to understand business challenges/opportunities and drive new innovative approaches to their resolution
- As a subject matter expert participate in project teams comprised of stakeholders, partners and peers
- Deliver product, technology and/or solution presentations to technical and business decision makers with audience engagement/interaction with clear communication
- Work closely with Business Analyst team and internal IT groups to facilitate issue resolution
- Manage critical systems with associated system processes to ensure problem resolution with both internal and external support teams
- Measure and monitor metrics for laboratory and manufacturing applications and support processes
- Provide escalated technical and production support on an on-call (24x7) basis
- Prepare documentation and training to support IT and related processes
- Possibly assist with off-hours monthly maintenance/patching and updating activities
- This role is located in Novato, CA, United States and will require up to 10% travel
- Minimum of 5-years’ experience in designing, building and supporting laboratory and/or manufacturing applications and systems in a customer facing, lead role
- Work experience in supporting and administering large scale Linux clusters nice to have.
- Demonstrated experience in leading teams implementing highly complex changes and upgrades in a 24x7 laboratory/manufacturing regulated environment
- Demonstrated ability to implement, upgrade and maintain systems with a rigorous change control environment from inception to release
- Experience with the following applications: Labware LIMS, Watson LIMS, MODA, Electronic Lab Notebook (IDBS ELN), AUVESY Version Dog, Lonza WinKQCL, Molecular Devices Softmax Pro, Thermo Scientific™ InSight, RURO FreezerPro, Beckman Coulter Vi-CELL, YSI Meter
- Experience with application and desktop deployment tools
- Experience working in a GxP or other regulated environment (e.g. FDA, EMA) with validated systems
- Proven ability to demonstrate technical expertise on various scales of IT projects
- Experience with application performance monitoring techniques, methods and metrics
- Troubleshooting and problem solving expertise is required to resolve issues with cross functional team including Infrastructure, Enterprise Applications and Security/Compliance departments
- Experience assessing and implementing business continuity plans related to 24x7 software systems
- Experience supporting software systems, servers and networks in Biotechnology Facility preferred
- Required familiarity with industry standard best practice SDLC process and system design documentation
- A strong communicator who can write and speak effectively to technical and non-technical audiences
- Experience leading people with active engagement in talent acquisition, development and coaching
- Able to build and execute project plans, and work closely with customers and IT to manage expectations
- Able to prioritize and deliver results with an emphasis on quality, technical rigor and attention to detail
- Able to integrate feedback in a professional manner and thrives in multidisciplinary highly diverse teams
- Candidate must be a strong team player recognizing personal improvement and awards are best achieved by making those around you successful
EDUCATION: Minimum B.S. or greater in Computer Science, Engineering, or a related technical field or significant experience in supporting laboratory and/or manufacturing platforms in the pharmaceutical industry.
SUPERVISOR RESPONSIBILITY: Managing small team 2-5 individuals.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.