Position Summary & Role
The scientist reports to the Senior Manager of In Process Testing and plans and performs routine testing of process development samples, review of data, troubleshoot experiments
Job duties include, but are not limited to in-process testing for Process Development runs, testing of upstream and downstream samples, and performing a range of additional varied work activities including:
- Tissue culture and maintenance of mammalian cell lines in an aseptic environment
- Performing in-process testing
- Lead and assist Lab Technicians in organizing daily activities
- General molecular biology methods associated with cloning, PCR, gel electrophoresis, viral assays, protein analytical assays, and virus/vector propagation
- Performing analysis of media, culture, and products
- Hands-on lab work associated with adherent or suspension cell culture, medium/buffer preparation, and cleaning/decontaminating of biosafety cabinets and incubators
- Perform work in a BSL-1, -2, or -3 environment
- Maintain PD inventory supply and ordering
- Work as a team with assay development, process development, QC, manufacturing, QA, and other departments as needed
- Contribute to the maintenance of laboratory equipment and laboratory support operations
- Assist in data analysis and troubleshooting
- Assist in development and optimization of technologies and processes to streamline testing
- Assists in drafting and reviewing standard operating procedures, work instructions, test methods, material specifications, and process development production records.
- Initiation of investigations, deviations, and implementation of resulting corrective actions into existing procedures. Assist in out-of-specification review via CAPA and/or change control forms.
- Write SOPs, work instructions, test methods, material specifications, and other product development documents.
- Assist in out-of-specification review via CAPA and/or change control forms.
- All other tasks as needed or assigned by supervisor.
Preferred Experience, Education & Qualifications (Education/Degrees/Certifications
- Degree in microbiology, biology, molecular biology, biochemistry, chemistry, or related field; BS +5 years; MS 1+ years of experience in laboratory sciences/biotech/biopharma. Ph.D. in same areas.
- Degree in microbiology, biology, molecular biology, biochemistry, chemistry, or related field; BS +7; MS 4+ years of experience in laboratory sciences/biotech/biopharma. Ph.D. in same areas with relevant industry experience
- Experience in process development, testing or manufacturing of biologics
- Experience with data analytics/data mining, statistics, high throughput data analysis is a plus
Other Ideal Personal Characteristics:
- Strong leadership, technical, communication, and organization skills in a teamwork environment
- Highly motivated individual
- Strong work ethic
This job requires the employee to perform the following physical activities:
- Repetitive motion
This job requires exposure to the following:
- Noise (enough noise to cause the employee to shout to be heard above ambient noise level.)
- Hazards: moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals).
- Hazards: packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.
- Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 2, including for emergency response.
- Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 3, including for emergency response.
- Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.
- Narrow aisles or passageways.
This job requires the employee to perform the following type of physical work:
- Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.
- Medium work. Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects
This job requires the following visual acuity requirements:
- preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.