Manufacturing Associate II
Job ID: req1434
Employee Type: exempt full-time
Facility: Frederick: ATRF
Location: 8560 Progress Dr, Frederick, MD 21701 USA
The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and 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.
Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest.
The Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports the National Cancer Institute (NCI) and other government agencies through the development of novel agents for first-in-man clinical studies.
- All phases of production (e.g., fermentation, purification, etc.)of clinical, biological and natural products under cGMP conditions
- Documenting in detail, using master production records or laboratory notebooks, the processes and manufacturing steps taken during the procedures
- Setting up, maintaining and operating equipment used in the manufacture of clinical, biological and natural products, including the manufacture of products and in-process testing
- Exercising judgment and using problem solving skills to obtain solutions; working to determine methods and procedures on new assignments
- Interfacing with Quality Control/Quality Assurance
- Writing Standard Operating Procedures and complete batch production records
- Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education)
- Foreign degrees must be evaluated for U.S. equivalency
- In addition to educational requirements, a minimum of two (2) years of job related experience
- Aseptic technique
- Ability to work flexible hours including occasional weekends
- Ability to lift up to 35 pounds and work in a BL2 environment
- Must be able to obtain and maintain a security clearance
- Experience with large-scale cell culture equipment and systems
- Experience with large scale chromatography equipment and systems
- Experience writing/reviewing technical documents, SOPs and/or master production records and maintaining accurate documentation of laboratory procedures
- Experience operating/maintaining computerized and complex production equipment
- Familiarity with cGMP regulations
- Ability to perform in-process tests such as gel electrophoresis, HPLC, etc.
- This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)