Lab Ops Technician II

Kite Pharma•Frederick, MD

1d•Onsite

About The Position

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. 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). Shift is Sun-Wed 1500-0130

Requirements

2+ Years with HS OR 1+ Years with AA
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.

Nice To Haves

Bachelor or Master’s degree in biotechnology

Responsibilities

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.