Biopharmaceutical Manufacturing Purification Lead

Biopharmaceutical Manufacturing Purification Lead

Job ID: req3832
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 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

• Implements production and large-scale manufacturing procedures to optimize processes and regulatory requirements.
• Responsibilities include scale-up and troubleshooting for equipment 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 improve procedures.
• Operate advanced chromatography/TFF/mixing systems, cGMP autoclaves and basic lab equipment
• Perform aseptic filtration and sampling
• Perform filter integrity testing
• Follow Standard Operating Procedures
• Complete Batch Production Records under cGMP
• Document in detail, through the use of Batch Production Records or laboratory notebooks, the processes and manufacturing steps taken during the procedures
• Order and maintain inventory of raw materials/components
• Revise and generate GMP documentation
• Lead production activities in the manufacturing area
• Train others within the working group and provide feedback to supervisor
• Interface with Quality Assurance/Quality Control
• Interact with customers and/or senior management
• Perform investigations and write deviations
• This position may require working on 2nd or 3rd shift and weekends as needed

BASIC QUALIFICATIONS

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   
• In addition to the education requirement, a minimum of five (5) years of progressively responsible job related experience in a pharmaceutical cGMP environment.
• Must possess basic Microsoft Office skills
• Experience using and programming chromatography systems
• Experience using and programming TFF (Tangential Flow Filtration) systems
• Experience with clarification processes (i.e. depth filtration, centrifugation)
• Knowledge of basic purification techniques of a variety of biomolecules
• Ability to interface with Quality Control, Quality Assurance, Materials Management
• Working knowledge of cGMPs and computer-assisted manufacturing and production equipment
• Clean room and BL2 experience
• Skills/experience in processes and equipment associated with column chromatography techniques from small to pilot scale
• Experience with aseptic filtration and sampling
• Ability to be gown certified
• Ability to lift up to 35 pounds
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Use of UnicornTM Software
• Use/packing of Pilot/Large Scale chromatography column hardware, 10cm-100cm diameter chromatography columns

 JOB HAZARDS

• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations

Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, 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.

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