KEY ROLES/RESPONSIBILITIES
- Responsible for performing production of clinical biological products under CGMP conditions
- Must be able to document in detail, through the use of master production records or laboratory notebooks, the processes and manufacturing steps taken during the procedures
- Must be able to solve problems of a very complex scope, exercise independent judgement and work independently on new projects
- Will be responsible for training others within this group
- Responsible for setting up, maintenance and operation of related equipment
- Will interface with Quality Control/Quality Assurance, write standard SOP's and review batch records
- May be required to supervise the activities of lower lever personnel
- Interface with other departments
**THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL**
BASIC QUALIFICATIONS
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
- Possession of Bachelor's degree 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 eight (8) years of progressively responsible experience
- Ability to operate computerized production equipment, i.e AKTA Pilots, AKTA Process etc.
- Experience writing/reviewing technical documents, SOPs and master production records and maintaining accurate documentation of laboratory procedures in accordance with cGMP
- Working knowledge of cGMP Biopharmaceutical Sciences and operations and department specific computer applications
- Ability to work flexible hours, including weekends and evenings
- Ability to work in a BL2 environment
- Ability to lift up to 25 pounds
- Ability to obtain and maintain a security clearance
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
- Knowledge of CGMP Biopharmaceutical Sciences and operations
- Laboratory environment and equipment used for pharmaceutical production
- Knowledge of Virus production and Virus Purification
- Experience with large scale chromatography equipment and systems
- Experience in virus production/purification
- Experience with technical transfer of GMP production processes
- Ability to perform in-process tests such as gel electrophoresis, HPLC, Elisa, Western blot, SDS-PAGE etc.
JOB HAZARDS
This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
Keywords: Pharmaceutical, clinical biology, CGMP, biopharmaceutical sciences. Monoclonal Antibody purifcation. Virus Purification