Manager, cGMP Cleaning
Location: Frederick
Posted on: June 23, 2025
|
|
Job Description:
Manager, cGMP Cleaning Job ID: req4307 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 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 Hours for position:
Monday-Friday 6:00 a.m. - 2:30 p.m. Manages a team of at least
seven (7) cGMP cleaning technicians. Performs all duties necessary
to maintain manufacturing suites, clean rooms, laboratories and
office facilities in a clean, safe, and orderly condition following
FDA and/or cGMP guidelines as applicable. Selects and prepares work
assignments/schedules for cleaning technicians; adjusts schedules,
assignments, and methods to accomplish work effectively and
economically. Determines locations that require special attention
to maintain cGMP compliance. Explains to cleaning technicians all
work requirements, methods, procedures and safety related
information. Reviews work for completeness and consistency. Orders
cleaning equipment and supplies to maintain inventory status. Works
with Safety Officer to define specific handling procedures for the
decontamination and disposal of biohazard material. Disposes of
scrap equipment in accordance with existing property handling
regulations. Drafts and revises SOPs to maintain cGMP compliance.
Participates in audits as required. Enters work orders into the
Regulatory Asset Manager (RAM) database. 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 four (4) years of progressively
responsible experience, including two (2) years of experience in a
leadership/manager capacity. Must possess basic Microsoft Office
skills. Ability to demonstrate the use of all materials, methods
and equipment to cleaning technicians. Ability to assist in the
writing of Standard Operating Procedures (SOPs). Ability to
interpret and respond to work orders, directives and/or SOPs.
Knowledge of cGMP cleaning procedures and industrial cleaning
methods. Knowledge of the use of proper materials for cleaning,
such as waxes, spot removing compound, detergents, deodorants and
other related chemicals; cleaning equipment and accessories and
their efficient, effective use. Ability to follow health standards
for cleaning medical/laboratory facilities. Ability to pass aseptic
gowning validation. Ability to pass respirator fit testing and
maintain training requirements. Ability to routinely lift and carry
up to 50 lbs. and occasionally up to 100 lbs.; climb stairs and
ladders; work involves bending, stooping, and working in confined
areas; potential exposure to particulates, vapors, or noisy
environment. Previous experience in GCP, GLP, or GMP regulated
environment. Must possess good verbal and written communication
skills and excellent documentation skills. Ability to obtain and
maintain a security clearance. PHYSICAL QUALIFICATIONS Physical
requirements include the ability to maintain balance at all times,
walk, kneel, hear (corrective appliance allowed), use of both
hands, arms and legs, 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 having
potential for exposure to infectious material, requiring medical
clearance and immunizations. Commitment to Non-Discrimination All
qualified applicants will receive consideration for employment
without regard to sex, race, ethnicity, color, 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. Pay and Benefits Pay and
benefits are fundamental to any career decision. That's why we
craft compensation packages that reflect the importance of the work
we do for our customers. Employment benefits include competitive
compensation, Health and Wellness programs, Income Protection, Paid
Leave and Retirement. More details are available here 70,200.00 -
120,625.00 PLEASE NOTE: The budgeted range for this position is
$96,500.00 to $120,625.00. 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. The salary range posted is
a full-time equivalent salary and will vary depending on scheduled
hours for part time positions
Keywords: , Arlington , Manager, cGMP Cleaning, Science, Research & Development , Frederick, Virginia