Manager, cGMP Cleaning

Manager, cGMP Cleaning

Job ID: req4263
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 4:00am-12:30pm.
• 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.
• Draft and revise SOPs to maintain cGMP compliance.
• Participate in audits as required.
• Enter 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 a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a related field or four (4) years qualifying experience in lieu of degree may be substituted for the required education. Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, must have 4 years’ experience including 2 years as a manager.
• 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).
• 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 atmospheric conditions that would require the usage of a respirator, requiring a medical clearance.
• This position is subject to working with or have 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

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