Top 8 Quality control scientist ii Jobs in Hagerstown, Md

Quality Control Scientist II
Frederick National Laboratory —Frederick, MD
- $84,500 - $121,124 a year
- Full-time
- Mid-level
- Supervising experience
- Doctor of Philosophy
Test Technician
Leonardo DRS —Frederick, MD
- Full-time
- Mid-level
- Experience equivalent to degree accepted
- Computer skills
- Paid parental leave
- Health savings account
Laboratory Space Manager II (#1904)
Battelle National Biodefense Inst —Fort Detrick, MD
- $56,121.61 - $92,722.66 a year
- Full-time
- Bachelor of Science
- Mid-level
- Ability to lift 50 pounds
Quick Apply
Laboratory Space Manager II (#1903)
Battelle National Biodefense Inst —Fort Detrick, MD
- $56,121.61 - $92,722.66 a year
- Full-time
- Bachelor of Science
- Mid-level
- Ability to lift 50 pounds
Quick Apply
Scientist II, Standardized Organoid Modeling Center
Frederick National Laboratory —Frederick, MD
- $103,100 - $147,767 a year
- Full-time
- Doctor of Philosophy
- Mentoring
- Fair chance
Research Associate II, Tissue/Organoid Engineering
Frederick National Laboratory —Frederick, MD
- $70,500 - $100,901 a year
- Full-time
- Mid-level
- Math
- Bachelor's degree
Scientist II, Stem Cell Lab (IPSC)
Frederick National Laboratory —Frederick, MD
- $103,100 - $147,767 a year
- Full-time
- Doctor of Philosophy
- Team management
- Fair chance
8d

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Quality Control Scientist II

Frederick National Laboratory -
Frederick, MD

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Job Details

Full-time
$84,500 - $121,124 a year

Qualifications

Health sciences research
USP standards
Medical writing
Customer communication
Immunological assays
Cell line culture
Content creation for technical audiences
Procedural guides
Immunological laboratory techniques
Technical writing experience within manufacturing
Good documentation practices (GDP)
Molecular diagnostic equipment
Flow cytometers
Trend analysis
ICH guidelines
Biochemical laboratory techniques
Doctor of Philosophy
Pharmaceutical analysis
Laboratory standard operating procedures
GMP for research safety and compliance
Regulatory compliance analysis
Standard operating procedures (SOPs)
Cytometry

Full Job Description

Quality Control Scientist II

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

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

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

Candidates with these desired skills will be given preferential consideration:

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.

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

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Refine Your Search

quality control scientist ii jobs in hagerstown, md

Quality Control Scientist II

Test Technician

Laboratory Space Manager II (#1904)

Laboratory Space Manager II (#1903)

Scientist II, Standardized Organoid Modeling Center

Research Associate II, Tissue/Organoid Engineering

Scientist II, Stem Cell Lab (IPSC)

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