Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
To learn more about us, please visit us at http://www.pharmacyclics.com/
General Position Summary/Purpose:
This is a lead role as administrator for a Laboratory Information Management System (LIMS) taking on development, configuration, testing and validation responsibilities for user functionality along with providing day to day support of business areas that utilize the system (Translational Medicine, Discovery and Research). Collaborate with Information Technology and Clinical Quality Assurance departments to ensure system requirements are met and are compliant with regulatory and business requirements. Duties include working with the laboratory and Translational Medicine personnel to optimize LIMS core and expanded user functionality for the biosample, laboratory and data management.
Key Accountabilities/Core Job Responsibilities:
- Responsible for the administration of the LIMS supporting laboratory operations to include, but not limited to, test code creation, rule creation, customized reports, modifications, user account management, barcode/printer management, LIMS dictionary creation and upkeep of systems administration tasks
- Collaborate with IT to develop new user functionality and expand existing user functionality of the LIMS
- Collaborate with the software engineering team and QA department to perform IQ/OQ/PQ, to facilitate validation activities; develop and/or execute test scripts as required
- Oversee and author the Standard Operating Procedures, User Guides, and other relevant documentation for the LIMS
- Ensure ongoing LIMS proficiency and provide company-wide training in respect to any changes or upgrades
- Collaborate with IT on business requirements to ensure adequate infrastructure support to LIMS
- Assist with change control impact assessments
- Participate in internal audit reviews of the system and system documentation
- Provides vendor management support by working with the LIMS vendor on future upgrades, modifications, and other business needs within the LIMS
- Recommends resources needed for proper upgrades or other maintenance functions of the LIMS
- Provides high-level project management for any LIMS projects using Agile Software Development Life Cycle (SDLC) best practices
- BS or MS in a life science, engineering or equivalent work experience
- Minimum of 6-8 years working within a GxP regulated setting (Laboratory, Quality, Manufacturing, IT)
- Knowledge of CGMP/ICH/FDA regulations with 21 CFR Part11 and GAMP knowledge
- Working knowledge of QC laboratory operations.
- Experience with change control and software validation
- Knowledge of LIMS basic coding and code reviews
- Must be able to interact and communicate effectively with other departments to meet project milestones and goals.
- Ability to prioritize and successfully manage complex and competing projects
- Strong written and interpersonal / verbal communication skills
- Detail-oriented with expertise in problem solving and solid decision-making abilities
- Ability to work in a fast-paced environment to meet client and internal demands under tight timelines
- Experience with STARLIMS is highly desirable