We Are Growing
Since our 2012 round of financing, much progress has taken place at Intarcia, including significant enhancements to our world-class manufacturing facility, the opening of our new headquarters in Boston’s Innovation Center, and the diversification of expertise on our Board of Directors and Leadership Team through new senior leaders who contribute vital new capabilities and experiences.
A key element of pride during our progress has been our ability to remain fully independent throughout our rounds of financing so that we continue to have full strategic and executional control over all aspects of our rapidly evolving business. While we are always accountable to our stakeholders, we are – and intend to remain – the driving vision and force behind our progress and our ultimate success.
As a key member of the IT Team, the Manger, Lab Informatics manages the daily operations of the Laboratory Management Systems (LMS) used by Intarcia’s R&D, Clinical and Commercial Quality Control teams for tracking and reporting clinical laboratory data and product quality. This role performs business and system analysis, solution implementation, support and administration while ensuring compliance with information technology policies, standards and procedures, as well as laboratory policies and regulatory procedures. The role works on multiple and varied projects and initiatives associated with the LMS system under the direction of IT and laboratory leadership. The primary role of the LMS Administrator is to manage new business needs and monitor the daily operation of the system; provide end-user support, troubleshooting, and training; and provide data management of laboratory data generated and transmitted to customers. This position requires knowledge of client/server design methodologies, object-oriented programming environments, and database administration. This position also requires knowledge of clinical laboratory data, laboratory instruments, and system validation and documentation practices in regulated laboratory environments.
Duties and Responsibilities:
- Function as the lab systems analyst and administrator to ensure proper operation of the lab system (i.e. Waters Nugenesis and Empower, LabX, Biovia), troubleshoot issues, and interact with IT staff, Administration, and system users.
- Establish and maintain LMS accounts for staff, including designating specific “Roles” with assigned functions and assign to staff.
- Work with the LMS vendor and contractors to ensure the Lab’s Functional Requirements are incorporated and properly functioning in the LMS.
- Maintain the various modules in LMS to ensure they capture the correct information pertaining to functionality that is deployed and performance within stated QA guidelines, results generation and approvals, and reporting of results.
- Perform testing and troubleshooting of the LMS system for any configuration, functionality or computing environment changes to ensure LMS is functioning properly.
- Work as a liaison between the personnel within and outside QC, IT personnel, laboratory personnel and vendor POCs to coordinate connectivity of the LMS with instruments and other related integrations.
- Create and maintain documentation including Change Request Forms, user access requests, training documentation, and system validation documents.
- Conduct training of staff which may include Power Point presentations as well as one-on-one instructions of personnel in the use of LMS system.
- Attend regular meetings to update staff on issues and of the LMS development progress.
- Work with IT staff to transfer Legacy data into the LMS and ensure its proper functionality.
- Develop and write additional LMS documents as needed including: SOPs; Training; Requirements; Validation and Test scripts.
- Responsible for monitoring of data integrity, risk analysis and evaluation of performance, and compliance with the local, state and federal regulations
- Perform other duties as assigned. Ensure site on-time implementation of LMS through support of requirements definition, functional design, master data configuration and data migration, system validation, SOP revisions and development and end-user training. Provide technical support of LMS to Quality Control operation.
Skills and Abilities:
In order to be successful in this role the successful candidate will leverage the following skills:
- Strong working knowledge of laboratory processes including cGMP’s in a pharmaceutical environment
- Experience in system testing, validation, and master data management
- Familiar with 21CFR part 11 ERES requirements
- Excellent written and verbal communications skills and the ability to lead and participate in team
- Experience or familiarity of the Laboratory Environment
- A hands-on leader with ability to lead teams, and be accountable for compliance and change control activities.
- Collaborate with stakeholders and contractors to manage the lifecycle of computerized systems and their associated documents
- Enforce relevant policies, processes, and practices
- Establish timeline and process to ensure IT annual and long-range planning are efficient; manage team to deliverables
- Ensure systems internal/external adherence to regulatory / industry / corporate / department / function regulations, policies, and procedures
- Act as ambassador for IT function across entire organization
- Inspire and drive the IT team to collectively meet or exceed agreed-upon levels of performance
- Create a positive, performance-based culture within IT that is built on trust, and aligns with the overall Intarcia culture
- The ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans
- Customer relationship management skills and Vendor management skills
- Must possess excellent communication, conflict resolutions, influence and problem-solving skills
- You are obsessed with making a meaningful difference in the lives of people living with serious chronic diseases like diabetes
- Strong attention to detail, quality oriented
- Must be self-motivated and comfortable in a fast-paced, demanding and dynamic work environment.
- You have superb communication and interpersonal skills along with ability to influence others
- You have a strong attention to detail combined with a simultaneous ability to always see the “big picture”
- You visibly uphold impeccable ethics and unquestionable integrity in all that you do
- You can translate concepts and ideas into timely action and high-impact results
- You have the demonstrated ability to work with multiple internal cross-functional teams and successfully manage multiple projects simultaneously
- You are able to communicate complex information and concepts succinctly and with impact
- You bring high energy, a collaborative spirit, and an entrepreneurial mindset
- You have shown the ability to thrive in a small but rapidly growing and changing organization; you are comfortable with ambiguity and uncertainty
- You are unwilling to settle for anything less than excellence in yourself and your team
Qualification and Experience:
- Bachelor’s Degree or equivalent in Engineering, Information Systems, Computer Science, Business or the Life Sciences.
- 8+ years’ experience working within information systems
- 5+ years biotechnology or pharmaceutical experience, experience with validated or controlled IT environments
- Strong collaboration, project management and process improvement skills, and the ability to function in multiple roles based on project demands
- Excellent oral, written and interpersonal communication skills
- Use of Activate, or otherAgile implementation methodologies
- Knowledge of LIMS solutions
- ITIL certification
- You have successfully managed multiple projects, large and small, at one time
- You have a proven ability to deliver on goals in a collaborative way
- 7-10 years of experience in implementation and administration of laboratory management systems.