QC Bioanalytical Analyst II
Job ID: req4668
Employee Type: exempt full-time
Division: Vaccine Clinical Materials Program
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 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 Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its’ mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.
KEY ROLES/RESPONSIBILITIES
- Evaluates and implements protocols and methods to inspect and test in-process raw materials and finished products and ensure that they are in compliance with internal and external safety, quality and regulatory standards requirements for distribution.
- Performs analysis and identifies trends in the inspection of finished products, in-process materials and bulk raw materials, and recommends corrective actions when necessary.
- Develops processes and tests to determine that appropriate quality control analysis is being performed.
- Prepares documentation for inspection/testing procedures.
- Evaluates and analyzes the efforts in organizing, documenting and interpreting inspection support documents and records.
- May assure compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma).
- Operates basic laboratory instrumentation and that of more medium or complex nature such as (but not limited to) imaging Capillary Electrophoresis (iCE3), GXII Touch, Octet and HPLC/UPLC technologies.
- Conducts routine and non-routine analytical analysis of in-process, finished product, and stability samples according to standard operating procedures (SOPs).
- Performs peer review of data to ensure compliance with SOPs, FDA, cGMP and GLP regulations.
- Follows good documentation practices to ensure appropriate documentation of test results.
- Prepares documentation for testing procedures.
- Performs required data analysis, compiles data, and summarizes results for review.
- Oversees laboratory instrumentation calibration and maintenance.
- Troubleshoots method and instrument issues to resolution.
- Participates in internal quarterly quality audits.
- Participates in OOS, non-conformances, trend investigations and change controls.
- Aids in the revision, review, and drafting of new and existing SOPs.
- Maintains the safety and orderliness of the lab in accordance with 5s principles.
- Plans tasks and activities with supervisor oversight on a weekly basis in accordance with established schedules, group objectives, and priorities.
- Receives, stores, and documents incoming receipt of samples, test articles, and materials utilized in bioanalytical testing and in accordance with cGMP best practices.
- Occasionally requires non-regular work hours and weekends as needed to support manufacturing activities.
BASIC QUALIFICATIONS
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
- Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a related field (Biology, Chemistry, Biochemistry, or related science), (Qualifying four (4) years equivalent, directly relevant, experience in a cGMP lab environment may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
- In addition to the education requirement, there is a minimum of two (2) years of job-related experience.
- Must possess basic Microsoft Office skills.
- Experience in a cGMP/GLP laboratory.
- Demonstrated working knowledge of basic laboratory skills and techniques (buffer and solution preparation, pH measurement, visual appearance testing, gel electrophoresis or ELISA), as well as experience with general Bioanalytical laboratory equipment including UV-Vis spectrophotometer and multi-detection plate reader.
- Ability to draft, revise, and follow cGMP SOPs related to laboratory instruments and simple test methods, assist with investigations, review data of minimal complexity and compile simple data analysis and report results.
- Ability to work with assistance on tasks of moderate complexity, demonstrating independent thought and scientific rationale.
- Ability to succeed in a team-oriented environment under instruction of supervisor and/or more senior analysts, operating under dynamic conditions and condensed timelines. Detail oriented with strong organizational and verbal communication skills.
- Ability to perform basic math skills.
- Ability to obtain and maintain a security clearance.
PHYSICAL QUALIFICATIONS
- Physical requirements include the ability to maintain balance at all times, walk, hear (corrective appliance allowed), lift/carry up to 50 lbs, reach above shoulders, climb step ladders/step-stools, push/pull, and stand for extended periods.
- Ability to wear Personal Protective Equipment (PPE).
- Capable of working in a laboratory with potentially hazardous chemicals.
- Ability to Operate equipment that uses compressed or liquid gas.
- Visual acuity to include depth perception and vision correctable to 20/40.
- Pacemaker prohibited.
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
- Some experience with any of the following Bioanalytical methodologies: PCR, Bio-layer Interferometry, Chromatography or Microfluidic Electrophoresis.
- Use of LIMS, EDMS, ERP, and other electronic systems.
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.
57,700.00 - 82,711.00 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
