Pharmacyclics, LLC

IT R&D Lab Analyst I

Location
Sunnyvale, CA, United States
Posted
Sep 13, 2018
Ref
2515
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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.

The IT R&D Lab Analyst I will be responsible for support of day to day lab systems working closely with Analytical Chemistry, Quality Control and Discovery labs. Primary duty is related to laboratory logistics and to maintain database of laboratory equipment and periodically audit this list for accuracy and completeness. Will be primary support personnel for systems utilized by Facilities/EH&S to support Maximo, Action-ERM, and other similar systems. The resource will also be involved in supporting other IT R&D applications as needed.

The IT R&D Lab Analyst I will become a valuable member of the Laboratory IT support team to deliver the future-state requirements and current-state system improvements. In addition to supporting the Labs, the IT R&D Lab Analyst will also contribute to driving innovation and seeking new technical solutions for R&D Labs and Facilities/EH&S.

This position requires:

  • Strong lab support experience as related to ensuring uptime of laboratory computerized systems installation, maintenance, troubleshooting, and vendor management.
  • Strong knowledge of information systems & workflows for lab assay data & knowledge management, data query & analysis, lab automation & LIMS, sample management, bio banking, CTMS, and inventory (e.g. lab equipment and chemicals)
  • Familiarity or experience with laboratory data management platforms such as electronic lab notebook and results & analysis platforms such as LIMS.
  • Oversight of Laboratory Systems requirements and configuration definition;
  • Ability to review and update policies, guidelines, and procedures relating to computer system validation.
  • Knowledge of validation lifecycle of lab computerized systems.
  • Assist with system configuration and general IT duties as needed.
  • Work collaboratively in a cross-functional setting, particularly with patient safety, vendors, CRAs, site staff, investigators and clinical operations. Must be team player, detail oriented and be willing to work in a fast-paced environment with time-sensitive materials in support of CTMS platform.

With core competency focused in:

  • Install, configure, and maintain computerized systems in compliance with relevant policies, guidelines, and procedures.
  • Function as support between IT, Quality organization, Analytical/Synthetic Chemistry, DMPK, Non-Clinical Safety, EH&S, Facilities, and Research Cancer Biology Groups.
  • System Administration of systems: Provisioning, De-provisioning, Database functionality, hardware resource monitoring, and back up/recovery.
  • Coordinate downtimes for project related upgrades, updates, and configurations.
  • Liaison to Analytical Chemistry, Quality Control, and Discovery groups in supporting Dissolution, LC, GC, and Mass Spectrometry Lab instruments.

The IT R&D Lab Analyst I should be comfortable working with users across the organization and with differing levels of technical expertise. Expected to deliver documentation and training with all solutions. This role has a high degree of customer interaction and requires a highly motivated individual with excellent verbal and written communication skills. Ability to plan and coordinate multiple simultaneous application efforts.

Job Responsibilities, Requirements and Education:

Experience
  • A minimum of 2-3 years practical work experience as an IT analyst is required with experience in a life sciences/healthcare organization.
  • Core IT fundamentals background
  • Familiar with 21 CFR Part 11, computer systems validation and GAMP.
  • Should be knowledgeable with the above standards and be able to deliver solutions in compliance.
  • Writing, reviewing and executing validation documents.
  • GMP/GLP Lab and instrumentation support background and experience
  • Familiar working in a research or GMP lab along with common chemical and biological hazards
  • Quick learner
  • Self-starter / tenacious problem solver / highly motivated
  • Ability to work on a team or independently
  • Ability to take projects from design to long-term maintenance
  • Excellent communication and documentation skills.
  • BS/MS in a related field

The following is a plus:

  • Familiar with drug discovery, translational medicine, and the IND/NDA process
  • Familiar with Enterprise wide LIMS implementation and support
  • Validation of Computer Systems and GAMP5 Methodology, CFPIE
  • Computer System Validation and the Change Control Process in Life sciences industry
  • Familiar with SharePoint 2010 including client/server architecture.
  • Office and desktop applications: Access, Word, Excel, PowerPoint, Outlook, InfoPath, Project, etc.


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