Vaccine Manufacturing Manager II Position
4 weeks ago
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.
As a Vaccine Manufacturing Manager II at BioSpace, Inc., you will oversee and direct the development, planning, implementation, and maintenance of manufacturing methods, processes, and operations for new or existing products and technologies. You will work closely with quality groups to ensure strict compliance with good manufacturing practices guidelines at all times. Additionally, you will prepare documentation, reports, and standard operating procedures as required.
Key Responsibilities
- Develop and implement manufacturing methods, processes, and operations for new or existing products and technologies.
- Ensure compliance with good manufacturing practices guidelines.
- Prepare documentation, reports, and standard operating procedures.
- Oversee and direct the work of production staff.
- Collaborate with quality groups to ensure compliance with regulatory requirements.
- Bachelor's degree in a scientific or engineering field or four years of relevant experience in a scientific or engineering field.
- Four years of progressively responsible experience, including two years in a leadership/manager capacity.
- 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.
- Unicorn software experience.
- Experience with filter integrity testing systems.
- Experience with Master Control software systems.
- 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.
- This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations.
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