Lead Manufacturing Fermentation Associate

Job ID: req3473
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.

PROGRAM DESCRIPTION
The Vaccine Clinical Materials Program (VCMP), part ofLeidos Biomedical Research at the Frederick National Lab, supports the NationalInstitute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center(VRC). Its’ mission is to advance preclinical and clinical research, productdevelopment, and manufacture of novel clinical-stage vaccines and biologics toaddress 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 plantfacility and is actively engaged in cGMP manufacture, testing, release, andsupply of Phase I /II clinical products for investigational use in the US andglobally.
KEY ROLES/RESPONSIBILITIES

• Implements production andlarge-scale manufacturing procedures to optimize processes and regulatoryrequirements.
• Responsibilities include operatingand troubleshooting for upstream equipment (stainless steel and Single UseBioreactors) and systems.
• May establish operating equipmentspecifications and improve manufacturing techniques.
• May assist with resolving technicalissues, as well as maintenance of production equipment.
• May review existing operational andprocess discrepancies in manufacturing and provide technical expertise toimprove procedures.
• Maintain bacterial and mammaliancell cultures.
• Follow standard operatingprocedures.
• Complete batch production recordsunder current good manufacturing practices.
• Document in detail, through the useof batch production records, the processes and manufacturing steps taken duringthe procedures.
• Lead production activities in themanufacturing area.
• Train others within the workinggroup and provide feedback to the manager.
• Interface with qualitycontrol/quality assurance.
• Interact with customers and/orsenior management.
• Write/revise SOPs.
• Perform investigations and writedeviations.
• This position may require work on2nd, 3rd, or weekend shifts as needed.

BASIC QUALIFICATIONS
To be considered for this position, you must minimally meetthe knowledge, skills, and abilities listed below:

• Possession of Bachelor’s degreefrom an accredited college/university according to the Council for HigherEducation Accreditation (CHEA) in a scientific related field (Qualifying four(4) years relevant experience in GMP manufacturing may be substituted for therequired education).
• Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the educationrequirement, must have a minimum of five (5) years of experience.
• Must possess basic Microsoft Officeskills.
• Experience with cGMP cell culturemanufacturing and production equipment.
• Ability to troubleshoot cellculture process and associated equipment, especially experience withbioreactors.
• Ability to assist in complexinvestigations including root cause analysis and corrective actiondetermination.
• Working knowledge of cGMP’s as theyrelate to manufacturing operations.
• Ability to write and followstandard operating procedures.
• Ability to assist in writing masterbatch records and complete Batch Production Records under Good ManufacturingPractices.
• Ability to perform aseptic gowningand to be gown certified.
• Cleanroom and BL2 experience.
• Ability to lift up to 35 pounds andwork in a BL2 environment.
• Ability to work 2nd or 3rd shiftand weekends as needed.
• Ability to obtain and maintain a security clearance.

PREFERRED QUALIFICATIONS
Candidates with these desired skills will be givenpreferential consideration:

• Previous lead associate experience.
• Ability to interface with QualityControl, Quality Assurance, Materials Management, Facilities and Validation.

JOB HAZARDS

• 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)
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