Vaccine Manufacturing Fermentation Engineer
- Employer
- Frederick National Laboratory for Cancer Research
- Location
- Frederick, MD, USA
- Start date
- Nov 9, 2019
View more
- Discipline
- Manufacturing & Production, Manufacturing/Mechanical
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioCapital
Job Details
KEY ROLES/RESPONSIBILITIES
- Participates in bioprocessing scale-up and technology transfer of Upstream processes (microbial and mammalian cultures)
- Troubleshoots problems, analyzing situations and data with in-depth evaluation of various factors
- Authors and revises documents (MBR's and SOP's) for upstream processes and equipment
- Performs root cause analysis for deviations, and defines corrective and preventive actions for potential improvements
- Provides process and equipment training for manufacturing associates
- Provides support for QA and Regulatory for investigations and audits
- Reviews documents for regulatory submissions
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria
- Support FAT, SAT and validation activities
- Evaluate new technology and provide suggestions for improvement of manufacturing processes
- Will work 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
- Possession of a Bachelor's degree from an accredited college or university (according to CHEA). (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
- In addition to education requirements, a minimum of five (5) years of progressively responsible job-related experience in a pharmaceutical cGMP environment
- Experience in working and troubleshooting of stainless steel and single use bioreactors
- Hands-on experience in mammalian and microbial processes and prior experience in process scale-up and tech-transfer
- Must be able to obtain and maintain a security clearance
PREFERRED QUALIFICATIONS
- Master's degree in biochemical engineering or related field
- 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 in leading cross-functional and departmental meetings
- Experience using Rockwell automation software
JOB HAZARDS OR REQUIREMENTS
- Candidate will be working with or have the potential for exposure to infectious material(s) or Other Potentially Infectious Materials (OPIM), requiring medical clearance and immunization in accordance with protocol requirements
Company
A rewarding career with global impact
Whether you’re an expert in your field or just starting out, we have a career opportunity for you. We’re always looking for people to join us in fulfilling the mission of the Frederick National Laboratory: discovery, innovation, and success in the biomedical sciences.
Our team of 2,400+ scientists, technicians, administrators, and support staff work at the forefront of basic, translational, and preclinical science, with a focus on cancer, AIDS, and other infectious diseases.
We collaborate with colleagues across the National Cancer Institute, National Institutes of Allergy and Infectious Diseases, and others throughout the National Institutes of Health. We also engage with extramural investigators in academia, government and industry.
Your path to joining our team begins with the desire to work for the only national laboratory dedicated to biomedical research. Our employees share a common desire to help make a difference in cancer research and public health concerns. As you search for a career that fits your education, skills, and abilities, explore the core values that guide us and emphasize work-life balance.
Discover why joining the Frederick National Laboratory team could be the most important career step you take
- Website
- https://frederick.cancer.gov/
- Phone
- 301-846-1000
- Location
-
8560 Progress Drive
Frederick
MD
21701
US
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