Vaccine Manufacturing Process Engineer, Purification

Job ID: req4244
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 for Cancer Research 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

• Responsible for the design and implementation of manufacturing processes, instrumentation and equipment from the laboratory through pilot plant and manufacturing scale-up.
• Provides expertise in cell culture, engineering, design and process and/or scale-up.
• Assists the manufacturing operation in problem solving with regards to equipment and systems.
• Develops and recommends new process formulas and technologies to achieve cost effectiveness and improved product quality.
• Recommends processes for the production of therapeutic products.
• Establishes operating equipment specifications and improves manufacturing techniques.
• Involved in new product scale-up, process optimization, technology transfer and process validation activities.
• Interfaces with various departments to ensure processes and designs are compatible for new product technology transfer and to establish future process and equipment automation technology.
• Serves as a Point of Contact (POC) for QA, regarding quality issues related to the Purification group.
• Initiates, facilitates progress, and closure of change controls.
• Investigates root cause, evaluation of product impact, and facilitates closure of deviations.
• Initiates, lead cross-functional team discussions, and completion of final report for risk assessments.
• Opens, facilitates implementation, and facilitates closure of Preventive Actions (PA).
• Opens, facilitates implementation, and facilitates closure of Corrective Actions (CA).
• Opens, investigates, determines root cause, proposes corrective/preventive actions for potential improvements, and facilitates closure of investigations.
• Serves as technical oversite during execution of the Purification production runs.
• Ensures process is performed as technology transfer (TT) process intended.
• Advises operators/Supervisor during unexpected or adverse outcomes.
• Acts as on-the-floor client liaison when client is on site observing operations.
• Participates in bioprocessing scale-up, technology transfer, and execution of Downstream processes.
• Troubleshoots problems where analysis of situations and of data requires in-depth evaluation of various factors.
• Authors and revises documents (MBR's and SOP's) for downstream processes and equipment.
• Provides process and equipment training for manufacturing associates.
• Provides support for QA and Regulatory for investigations and audits.
• Reviews documents for regulatory submissions when required.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining solutions.
• Supports FAT, SAT and validation activities.
• Evaluates new technology and provides suggestions for improvement of manufacturing process.
• Will work directly with government process development scientists in the performance of assigned duties and will be responsible for ongoing communications to working groups and project teams.

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of Bachelor's degree in biological sciences, biochemistry, biochemical engineering, or related field 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 with progressively responsible job-related experience in a pharmaceutical cGMP environment.
• Hands-on experience in downstream purification processes.
• Experience in working and troubleshooting of manufacturing equipment.
• Experience in process scale-up and tech-transfer.
• Experience leading cross-functional and/or departmental meetings.
• Must possess basic Microsoft Office 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, use of all fingers, lift/carry up to 50 lb, 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.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Master's degree in biochemical engineering or related field is desired.
• Engineering analysis of bioprocessing methods; may include a specialty in downstream purification (e.g., filtration, ultrafiltration, chromatography separations, system programming) or bioreactor cell culture/fermentation (e.g., cell expansion, bioreactor control and analysis, centrifugation and depth filtration for clarification).
• Experience using MasterControl quality record management software.
• Experience using Unicorn software for operation of Cytiva (formerly GE) process equipment.
• Experience using continuous flow centrifuges.

JOB HAZARDS

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

Leidos BioMed Commitment to Non-Discrimination
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.

84,900.00 - 145,875.00

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.

#readytowork

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions

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