Associate Director, Quality Control- Analytical Tech Services

Gilead Sciences•Frederick, MD

1d•Onsite

About The Position

We are seeking a highly motivated individual to join us as an Associate Director, to lead Quality Control Analytical Tech Services group, reporting to the Senior Director, Quality Control in Frederick, MD. In this role, you will lead a group and work closely with the Senior Director and other Associate Directors on supporting commercial operations in CAR-T technology. You will work on complex projects involving qPCR/ddPCR, Flow cytometry and cell-based bioassays and lead efforts in automation development for analytical assays. You will have cross-functional interaction with personnel from other groups such as Quality Assurance, Analytical Development, Manufacturing, Material Management (MM) and Corporate teams.

Requirements

Advanced scientific degree (i.e. MD, PharmD, PhD) and 2+ years’ experience in biologics/cell-gene therapy in QC Analytical, Analytical Development environment OR Master’s Degree and 8+ years’ experience in biologics/cell-gene therapy in QC Analytical, Analytical Development environment OR Bachelor’s Degree and 10+ years’ experience in biologics/cell-gene therapy in QC Analytical, Analytical Development environment OR High School Degree and 14+ years’ experience in biologics/cell-gene therapy in QC Analytical, Analytical Development environment

Nice To Haves

Experience supervising/managing analytical labs within the biotechnology or pharmaceutical industry
Well versed and experienced in bioanalytical methods working under GMP conditions.
Deep experience in applying GMP in QC lab in conformance to US, EU and ROW standards.
Experience in conducting investigations, writing deviations, implementing CAPA and initiating change controls.
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211), Quality Control, GMPs, GLP
Ability to effectively negotiate and develop collaboration within teams and amongst individuals.
Demonstrated ability to create and maintain highly functioning teams.
Excellent interpersonal, verbal and written communications skills which are essential in this collaborative work environment
Comfortable in a fast-pace small company environment with minimal direction and able to adjust workload based on changing priorities.

Responsibilities

Provide technical support, process trending and procedural updates
Lead method validation and method transfers support continuous improvement, to support method/product/invalid trending, and to investigate laboratory/assay related findings.
Lead and support method development, validations, and transfers
Support laboratory investigations, deviations, CAPAs, change control as needed
Assist in investigation, identify root cause for critical deviations and determine CAPA for QC as needed
Establish data analytics to serve as metrics for monitoring trends in methods, products, and invalids
Support incoming tech transfers from AD/PD as needed
Author technical reports and protocols in support of cGMP activities
Supervise, train, and mentor junior staff
Create and/or revise procedures, SOPs, and test methods as needed
Support equipment and software lifecyle process
LIMS development and integration
Provide technical expertise for AD/PD, QA, Regulatory, Manufacturing, and Supply Chain as needed
Support and participate inspection readiness plans and participate during compliance audits (internal and external) and regulatory inspections.
Follow technology changes, recommends new technologies, advises on technology purchases and implementation if appropriate.
Additional duties as assigned.