Quality Control Scientist II

BioSpace; Frederick (MD); On-site; USD 85,000 - 121,000; Full time

Job summary

Leidos Biomedical Research, Inc. is seeking a highly trained scientist for the Biopharmaceutical Development Program in Frederick, MD. The role emphasizes development and validation of analytical methods for R&D, GMP release, and stability testing.

You will establish specifications for in-process materials, perform method validation, and contribute to data packages for regulatory review while collaborating with multi-disciplinary teams.

Qualifications

• PhD in a related field with hands-on lab experience in biopharmaceutical/biotech research.
• Minimum of two years of related experience.
• Deep expertise with flow cytometry and cell-based infectious titer methods.
• Extensive experience with cell culture and ELISA-based assays.
• Knowledge of GMP, USP, ICH and FDA guidelines related to product testing.

Responsibilities

• Facilitate transfer of analytical methods into the BDP or out to a client/customer.
• Develop analytical methods 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 qualification or validation of new or updated assays.
• Develop, revise and review SOPs, protocols and technical reports.
• Analyze assay performance through trend analysis, stability reports, and troubleshooting.

Skills

Flow cytometry

Cell-based assays

ELISA

qPCR/ddPCR

Education

PhD in related field

Tools

SOPs

Job description

Job ID: req4558

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 hands-on laboratory experience in biomedical research/biotechnology/biopharmaceutical or related field. 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 lead/supervisory role
• Experience with next generation sequencing

JOB HAZARDS

• This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations.

Commitment to Non-Discrimination

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

Pay And Benefits

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here

84,500.00 - 121,124.00 USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions