Senior Manager, QC Raw Materials

Allogene Therapeutics•Newark, NJ

4d•Onsite

About The Position

Allogene Therapeutics is a clinical-stage biotechnology company focused on developing allogeneic CAR T cell therapies for cancer and autoimmune diseases. We are seeking a highly motivated Senior Manager, QC Raw Materials to join our Quality team. This role will oversee the raw materials management program, including inspection, sampling, and testing, both internally and at external laboratories. The position requires onsite presence 5 days a week at our manufacturing facility in Newark, CA, and reports to the Director, Quality Control.

Requirements

Bachelor’s degree in chemistry, biochemistry or related field (advanced degree preferred) with at least 6 years of relevant experience in the biotechnology or pharmaceutical industry
Experience of managing external contract laboratories and vendors
Strong understanding of GMP requirements and QC systems as well as regulations pertaining to raw materials management
Strong technical knowledge and writing skills to draft protocols, reports, and investigations
Experience using LIMS and/or SAP systems to manage sampling, testing and release of raw materials
Experience interacting with regulatory agencies, supporting inspections as well as experience with regulatory filings
Experience in managing and investigating deviations
Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
Ability to work independently and as part of a team
Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
Candidates must be authorized to work in the U.S.

Nice To Haves

advanced degree preferred

Responsibilities

Responsible for the overall strategy, direction, oversight, planning, implementation and day to day operation of the raw material program and ensuring the compliant inspection, sampling and testing of raw materials within agreed upon turn-around time (TAT)
In collaboration with QA and Process and Analytical Development, support the Allogene raw materials program to create phase appropriate raw materials specifications and qualify vendors
Support vendor qualification program, ensuring project timelines and budget are met
Provides technical guidance to external contract laboratories related to RM testing and investigation as needed
Hire, train, and manage QC analyst(s) responsible for raw materials inspection
Represent QC on SAP team to build raw materials related metadata
Oversee the raw materials sample management and testing in LIMS system
Author submission documents related to RM specifications and testing.
Interact with internal auditors/external inspectors as needed
Support activities related to raw materials vendor changes and represent QC on RM review board.
Collaborate cross functionally and builds relationships with internal stakeholders within QC, QA, Regulatory Affairs, Development, Manufacturing and with external customers to meet target milestones
Other duties as assigned