Lead Manufacturing Fermentation Associate
Job ID: req3761
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 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.
Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.
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
- Implements production and
large-scale manufacturing procedures to optimize processes and regulatory
- Responsibilities include operating
and troubleshooting for upstream equipment (stainless steel and Single Use
Bioreactors) and systems.
- May establish operating equipment
specifications and improve manufacturing techniques.
- May assist with resolving technical
issues, as well as maintenance of production equipment.
- May review existing operational and
process discrepancies in manufacturing and provide technical expertise to
- Maintain bacterial and mammalian
- Follow standard operating
- Complete batch production records
under current good manufacturing practices.
- Document in detail, through the use
of batch production records, the processes and manufacturing steps taken during
- Lead production activities in the
- Train others within the working
group and provide feedback to the manager.
- Interface with quality
- Interact with customers and/or
- Write/revise SOPs.
- Perform investigations and write
- This position may require work on
2nd, 3rd, or weekend shifts as needed.
To be considered for this position, you must minimally meet
the knowledge, skills, and abilities listed below:
- Possession of Bachelor’s degree
from an accredited college/university according to the Council for Higher
Education Accreditation (CHEA) in a scientific related field (Qualifying four
(4) years relevant experience in GMP manufacturing may be substituted for the
- Foreign degrees must be evaluated for U.S. equivalency.
- In addition to the education
requirement, must have a minimum of five (5) years of experience.
- Must possess basic Microsoft Office
- Experience with cGMP cell culture
manufacturing and production equipment.
- Ability to troubleshoot cell
culture process and associated equipment, especially experience with
- Ability to assist in complex
investigations including root cause analysis and corrective action
- Working knowledge of cGMP’s as they
relate to manufacturing operations.
- Ability to write and follow
standard operating procedures.
- Ability to assist in writing master
batch records and complete Batch Production Records under Good Manufacturing
- Ability to perform aseptic gowning
and to be gown certified.
- Cleanroom and BL2 experience.
- Ability to lift up to 35 pounds and
work in a BL2 environment.
- Ability to work 2nd or 3rd shift
and weekends as needed.
- Ability to obtain and maintain a security clearance.
Candidates with these desired skills will be given
- Previous lead associate experience.
- Ability to interface with Quality
Control, Quality Assurance, Materials Management, Facilities and Validation.
- 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)