Vaccine Manufacturing Manager II

Vaccine Manufacturing Manager II

Job ID: req4121
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

• Oversees and directs the development, planning, implementation and maintenance of manufacturing methods, processes and operations for new or existing products and technologies.
• Works closely with quality groups to ensure strict compliance with good manufacturing practices guidelines at all times.
• Prepares documentation, reports and standard operating procedures as required.
• Ensures the effective use of materials, equipment and employees in producing quality products.
• May monitor and control labor and capital expenditures. May assist in developing budgets.
• Formulates and recommends manufacturing policies, procedures and programs.
• Selects, develops and evaluates personnel to ensure the efficient operation of the function.
• Operate advanced buffer/media skid, chromatographic skid equipment, cGMP autoclaves, and basic lab equipment.
• Perform aseptic formulation and filling, controlled rate freezing.
• Perform in-process sampling, formulation of raw materials.
• Perform column packing/unpacking and qualification of columns from 10 cm to 63 cm ID.
• Operate Tangential Flow Filtration (TFF) filters, holders, and systems.
• Perform filter integrity testing.
• Management and oversight of the purification group to include planning, implementation and execution of purification processes including operations of new products and technologies to support purification of vaccines to clinical supply under cGMP.
• Assure purification equipment operates in a state of cGMP compliance.
• Provide leadership and subject matter expertise for purification execution.
• Provide technical leadership in solving purification process issues.
• Responsible for collaborating with client when appropriate.
• Responsible for meeting schedule deadlines.
• Participate in both internal and external VCMP audits.
• Ensure regulatory compliance is maintained in the manufacture of all drug products.

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 a scientific or engineering field in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency.   
• In addition to the education requirement, a minimum of four (4) years of progressively responsible experience.
  • Including two (2) years of experience in a leadership/manager capacity.  
• Must possess basic Microsoft Office skills.
• Working knowledge of cGMPs and computer-assisted manufacturing and production equipment
• Purification experience in contract manufacturing setting.
• Skills/experience in processes and equipment associated with depth filtration techniques
• Ability to interface with Quality Control, Quality Assurance, Materials Management
• Clean room and BL2 experience
• Skills/experience in processes and equipment associated with column chromatography techniques from small to pilot scale
• Skills/experience in processes and equipment associated with tangential flow filtration techniques
• This position may require working on 2nd or 3rd shift and weekends as needed.
• This position is considered safety-sensitive and will be subject to random drug testing per the Leidos Biomedical Research Drug Free Workplace Program.
• Ability to obtain and maintain a security clearance.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Unicorn software experience.
• Experience with filter integrity testing systems.
• Experience with Master Control software systems.

PHYSICAL REQUIREMENTS

• Physical requirements include the ability to maintain balance at all times, walk, kneel, hear (corrective appliance allowed), use of both hands, arms and legs, use of all fingers, lift/carry up to 50lb, reach above shoulders, climb ladders, push/pull, bend repeatedly and stand for extended periods.
• Ability to respond to verbal instruction and cues in a sterile environment where staff are wearing face masks.
• Ability to wear Personal Protective Equipment (PPE).
• Ability to Enter a Laboratory or Encounter a Hazardous Area.
• Ability to Operate and/or service equipment that contacts or transports compressed or liquid gas.
• Ability to withstand exposure to temperatures below 32 degrees indoors for small amounts of time.
• Visual acuity to include depth perception and vision correctable to 20/40.
• Pacemaker prohibited.

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.

90,500.00 - 155,625.00

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

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