Job Details - Manufacturing Manager I/II - 39755170 | Frederick National Laboratory Talent Network
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Manufacturing Manager I/II in Frederick, MD

Location: Frederick, MD
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

Manufacturing Manager I/II

Job ID: req1936
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.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

 Position Overview:

PROGRAM DESCRIPTION         

The Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports the Frederick National Lab for Cancer Research (FNLCR) and other government agencies through the development of novel agents for first-in-human clinical studies. 

KEY ROLES/RESPONSIBILITIES

  • All phases of production of clinical, biological products under cGMP conditions
  • Document in detail, through the use of master production records or laboratory notebooks, the processes and manufacturing steps taken during the procedures
  • Exercise judgment and use problem solving skills to obtain solutions and work independently to determine methods and procedures on new assignments
  • Set up, maintain and operate equipment used in the manufacture of clinical, biological products, including the manufacture of products and in-process testing
  • Interface with Quality Control/Quality Assurance
  • Write Standard Operating Procedures and complete batch production records
  • Taking the lead in the development of procedures to perform virus production and purification under cGMP conditions
  • Taking the lead in the development of procedures to perform cell therapy production and purification under cGMP conditions
  • Taking the lead in set up and commissioning of new cell therapy production suites and equipment
  • Technology Transfer and GMP scale up evaluation and development
  • Analytical method and process development for Technology Transfer
  • Filtration, Clarification, Ultrafiltration/Diafiltration development under GMP conditions
  • Analysis method development and implementation (LAL, TOC, ELISA, Western blot, SDS-PAGE, HPLC etc.)
  • Development and implementation of Bacterial, Mammalian, Hybridoma and Insect cell cultures
  • Develop production schedules and assist Department Manager in implementation
  • Develop training curriculum and assist Department Manager in implementation

BASIC QUALIFICATIONS

This position may be filled with a Manufacturing Manager I/II commensurate with the selected candidates experience. 

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) or four (4) years relevant experience in lieu of degree.  Foreign degrees must be evaluated for U.S. equivalency
    • Manufacturing Manager I - In addition to the education requirement, a minimum of four (4) years of progressively responsible experience, including two (2) years of experience in a management capacity
    • Manufacturing Manager II - In addition to the education requirement, a minimum of six (6) years of progressively responsible experience, including four (4) years of experience in a management capacity
  • Demonstrated experience in the area of operating/maintaining computerized and complex production equipment
  • Experience writing/reviewing technical documents, SOPs and master production records and maintaining accurate documentation of laboratory procedures in accordance with cGMP
  • Working knowledge of cGMP Biopharmaceutical Sciences and operations and department specific computer applications
  • Ability to work flexible hours including occasional weekends
  • Ability to lift up to 25 pounds and work in a BL2 environment
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Eight (8) years of experience
  • Experience in virus production/purification
  • Experience with technical transfer of GMP production processes
  • Supervisory/Leadership experience
  • Experience in Cell therapy processes

EXPECTED COMPETENCIES

  • Aseptic techniques

JOB HAZARDS

  • This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
  • This position is subject to atmospheric conditions that would require the usage of a respirator, requiring a medical clearance

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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