Senior Analyst, QC LIMS and Operational Support (Orlando, FL)

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Why Work for Us

Are you ready to use your experience and expertise to make an impact on patients’ lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you’d like to be a part of this important mission, please apply to join our team.

About Astellas Gene Therapies

Astellas Gene Therapies is developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for the newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.audentestx.com.

Our Values:

  • Be BOLD (Find a Way)
  • Care Deeply – for our patients, each other and our work
  • #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

Astellas Gene Therapies is seeking an experienced Senior Analyst, QC LIMS and Operational Support, to join the Quality Control Systems group. Reporting to the Manager, Quality Control Systems Support, the Senior Analyst, QC LIMS will be responsible for defining the requirements for implementation of a LIMS for QC, managing the requirements for the ongoing operations and lifecycle of LIMS usage and act as the primary interface between QC and IT for LIMS. This role will work closely with the IT LIMS technical lead. In addition, this role will be responsible for defining the requirements for implementation and management of other QC tools, such as LIMS interface with ERP, data servers, bar code readers and electronic laboratory notebooks. This role is based in Sanford, NC at our new, state of the art manufacturing and laboratory facility.

Primary Responsibilities

  • Collaborate with Sanford QC laboratory users to define requirements for LIMS implementation and usage in QC.
  • Collaborate with LIMS IT technical lead to help translate the business requirements into technical solutions in LIMS.
  • Develop and maintain LIMS configuration documentation and plan for new product, equipment, and workflows. Provide first line of troubleshooting LIMS issues for QC users.
  • Manage the operations of LIMS in a validated environment and develop policies and procedures related to compliance requirements.
  • Work with QC functions to develop user requirements and configuration documents and manage vendor IQ/OQ of equipment.
  • Develop, revise, and review SOPs, protocols and reports and other documents to support QC equipment, LIMS and other computerized systems.
  • Lead the requirements definition for other QC systems, such as LIMS interface with ERP, data servers, bar code readers, and electronic laboratory notebooks.
  • Perform business administration activities for other QC Lab software such as the Empower chromatography system and the LabX system which supports lab instruments like balances, pH meters and conductivity meters.
  • Develop and provide computerized system and LIMS training to new users and grant system access.
  • Ensure lab compliance with applicable cGMP regulations and SOPs, and support both internal and external
  • Collect and report, track and maintain metrics for QC systems/equipment and QC users.
  • Initiate and project manage change controls for QC lab computer systems
  • Provide guidance and training to junior colleagues and oversee training activities for groups.
  • Assist users with queries, reports, and tracking/trending of QC lab data.
  • Provide operations support to end users and provide guidance in the implementation of new LIMS functionality.
  • Troubleshoot issues, solve problems, and assist with investigations and deviations.
  • Ensures that the integrity and accuracy of all laboratory documents are maintained; must assess overall document compliance with protocols, SOPs, company policies, and applicable regulations.
  • Create new and update current methods and specifications in LIMS.

About you

Must Have/Required

  • B.S. degree in biological sciences, cell biology, chemistry, or related field with 5+ years or M.S. degree with 3+ years of relevant experience in working with analytical computerized systems
  • Prior laboratory hands-on experience with a variety of analytical computerized systems
  • Experience using LIMS as an end user (e.g., QC Analyst performing data entry in LIMS)
  • Experience as a System Administrator for QC Laboratory computer systems (including LIMS, Empower). Includes experience with configuring and testing LIMS master data
  • Expertise in regulations governing data integrity and computerized systems
  • Experience in qualification of analytical equipment, including those with computerized systems
  • Experience with MasterControl or other EDMS (Electronic Data Management System)
  • Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment
  • Strong knowledge of GMP, SOPs and quality control processes
  • Strong knowledge of quality systems and regulatory requirements
  • Good to excellent technical writing skills and verbal communication skills
  • Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion with a focus on quality and attention to details
  • Highly self-motivated and goal oriented
  • Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

May Have/Preferred

  • Experience and knowledge in implementation and management of LIMS
  • Experience in translating laboratory user requirements to IT implementations
  • Experience with Windows OS, domains, networks and basic computing infrastructure in lab environment. Includes commercial-off-the-shelf (COTS) lab computer systems.
  • Experience conducting data integrity (DI) assessments and the associated DI remediation activities
  • Experience serving as a change agent and driving continuous improvement and automation across QC

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

More Information on Astellas Gene Therapies
Astellas Gene Therapies operates in the Biotech industry. The company is located in San Francisco, CA. Astellas Gene Therapies was founded in 2012. It has 395 total employees. To see all 52 open jobs at Astellas Gene Therapies, click here.
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