United States flag

Lab Ops Technician II

United States - Maryland - FrederickQualityRegular
apply

Job Description

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses

worldwide.

The ideal candidate is well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals. Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).As a Lab Ops Technician II, you are responsible for (but are not limited to):

  • Perform testing of raw materials, intermediates and final products by following analytical methods.

  • Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assays.

  • Track and test products according to Stability protocols.

  • Work with internal and external resources to maintain lab in an optimal state.

  • Monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product release.

  • Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.

  • Develop, revise and review SOPs, qualification/validation protocols and reports.

  • Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures. Provide updates at daily and weekly meetings.

  • Monitor the GMP systems currently in place to ensure compliance with documented policies.

  • Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.

  • Gather metric information for use in continuous improvement of areas of responsibility.

  • Perform other duties as required.

****Shift is Wed-Sat 0700-1730 or 1500-0130****

Required experience:

  • Strong knowledge of GMP, SOPs and quality control processes.

  • Identifying, writing, evaluating, and closing OOS’s and investigations.

  • Proficient in MS Word, Excel, Power Point and other applications.

  • Strong written and verbal communication skills.

  • Ability to communicate and work independently with scientific/technical personnel.

  • Bachelor or Master’s degree in biotechnology


Basic Qualifications:

2 years exp with High school diploma OR 1 year exp with Associate degree