Quality Control Scientist II Job Frederick area,Maryland USA,Quality Assurance

Job

Employee Type: exempt full-time

Division:
Biopharmaceutical Development Program

Facility:
Frederick: ATRF

Location:

8560 Progress Dr, Frederick, MD 21701 USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way. Program Description

The Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports the Frederick National Laboratory for Cancer Research (FNLCR) and other government agencies through the development of novel agents for first-in-man clinical studies.

Key Roles/Responsibilities

Assay Development and Qualification

Where applicable, facilitate the transfer of analytical methods either into the BDP or out to a client/customer
Development of analytical methods used for R&D characterization, GMP release and/or stability testing
Establish specifications and control limits for in-process materials and final drug substance/product
Facilitate the qualification or validation of new or updated assays
Develop, revise and review SOPs, protocols and technical reports
Responsible for the analysis of assay performance through trend analysis, stability reports, and investigating analytical and bioassay method technical issues

Sample Testing

Testing of samples submitted for release or stability testing.
Issue summary reports of testing, certificates of analysis/certificates of testing, and other data summary reports
Review QC test reports and data for compliance with established protocols and specifications

Quality

Support of QC functions (OOS, equipment logbooks, deviations, audits, investigations, CAPA, training, change control, and technical reports)
Assist in the preparation of reports and data packages for interactions with regulatory agencies

Leadership

Communication of key findings or method details with customers, as needed
Supports training of staff
Serves as subject matter expert in flow cytometry and cell-based titer assessments
Collaborates as a team member with strong adaptability, positive mindset and supportive attitude in multidisciplinary team

Basic Qualifications

Possession of a PhD degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a related field with ≥ 4 years of hands‑on laboratory experience in biomedical research/biotechnology/biopharmaceutical or related field (more experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
In addition to the education requirement, a minimum of two (2) years of related experience
Deep expertise with the development of flow cytometry and cell-based infectious titer methods
Extensive experience with cell culture methodologies
Experience with the development of ELISA‑based assays
Experience with qPCR/ddPCR‑based analyses
Biotechnology field knowledge in analytical, biochemical, and immunological testing
Ability to implement a rigorous testing program with appropriate operating procedures and cGMP compliance
Experience in data evaluation, trending, and troubleshooting
Excellent technical writing skills
Knowledge of the USP, ICH and FDA guidelines related to product testing
Knowledge of GMPs, SOPs, good documentation practices and quality control operations
Ability to obtain and maintain a security clearance

Preferred Qualifications

Experience working in a GMP environment
Experience with retroviral/lentiviral vector release testing
Understanding of CAR‑T cell therapeutics
Prior experience with analytical method qualification/validation
Background in immunology, with demonstrated application to assay development or cell-based systems
Understanding of equipment IQ/OQ/PQ
Proficiency with Microsoft Office, data analysis software, and other lab related applications
Strong written and verbal communication skills.
4 years post‑doctoral experience in a…