- This position will lead manufacturing teams involved in production related activities in the cGMP Manufacturing Core at the Medical Counter Measures (MCMs) Advanced Development and Manufacturing Facility in Alachua (Florida).
- Lead and perform upstream related activities including Cell culture at small and large scale using various cell lines, Cell transfection, Media and buffer preparation, Bioreactor and Fermentor based production.
- Lead and perform downstream related activities including Chromatography purification, Centrifugation and Ultracentrifugation, Ultrafiltration/Diafiltration, Viral Clearance.
- Contribute to process development and process improvement. Evaluate processes for efficiency and facilitate process transfer into the manufacturing core.
- Plan production activities and allocate manufacturing personnel to production campaigns as appropriate.
- Determine appropriate procedures necessary for production efficiency, cost saving and manufacturing operators welfare under cGMP conditions.
- Write and ensure that Standard Operation Procedures are issued in timely manner for production activities.
- Write, review and /or approve Change Control, Deviations.
- Ensure that materials used during manufacturing are properly disinfected and staged into production rooms before the production campaigns.
- Identify, evaluate and order equipment. Oversee equipment installation, qualification and routine maintenance.
- Write or review Production batch records and review executed records.
- Write material specifications, research and source material and lab wares.
- Write production reports when necessary.
- Perform change-over cleaning in the manufacturing core and other production rooms.
- Perform activities necessary to support production campaigns such as preparation of tubing assemblies, autoclave, material request and transfer into production room.
- Adhere to safe working practices.
- Provide assistance to the Manufacturing Manager as needed.
- Meet with the Manufacturing Manager at least on a weekly basis to discuss goals, planning, progress.
Minimum Educational Requirements for Competency
- Possess a B.S. (Biology, Microbiology, Molecular Biology, Virology, Immunology, Chemistry, Engineering, Biochemistry, Material Science or related field) with a minimum of 5 years of work experience in cGMP environment.
- Hands on experience in cell culture (small and large scale), transfection, infection, vaccine or vector production.
- Hands or practical experience with upstream and downstream processing methods.
- Ability to document work clearly and accurately. Detail oriented.
- Must have basic computer skills and familiar with Word, Excel and PowerPoint.
- Legible writing skills. Ability to maintain accurate records.
- Excellent communication skills including technical writing and organization skills. Teamwork and team leader with exceptional interpersonnel skills.
- Experience working as a team member sharing responsibilities.
- Ability to work independently and within the manufacturing group to complete assigned tasks.
- Flexibility, Self-motivation and team motivator.
- Efficiency and responsibility, hard working.
This position will be based in Alachua, FL.
To apply submit your resume to email@example.com with the position in the subject line.