Position Summary & Role
The scientist reports to the Associate Director or Senior Manager of Biologics and performs method development, product and process development, scale up/scale down processing, and performing a wide variety of activities including but not limited to the following responsibilities.
Job Responsibilities (core responsibilities; include people management if applicable)
- Operation and maintenance of lab-scale and process scale chromatography systems (GE Akta systems, Unicorn 7).
- Operation and maintenance of lab-scale and production scale filtration systems including manual and automated normal flow and tangential flow filtration, depth filtration, centrifugation, and other clarification systems.
- Tissue culture and maintenance of engineered cell lines
- Development of adherent flatware processes associated with T-flask, cellstack, and hyperstack platforms
- Perform work using fixed-bed bioreactors and stirred tank reactors up to 200L in scale
- Perform work using fermentors ranging from 3L to 300L in scale
- Assist in data analysis related to upstream processes, assays, and experimental outcomes
- Developing upstream/downstream processes
- Preparation and formulation of buffers defined in standard operating procedures
- 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.
- Maintenance of activity records, log books, and general inventories in designated laboratory areas following GDP standards.
- Perform general cleaning and sanitization of equipment and general production areas according to procedures.
- Expression and purification of recombinant proteins using a variety of expression systems.
- General laboratory methods, such as filtration, centrifugation, bio-separations, spectroscopy, light microscopy and image analysis.
- Assist in research, product and process development for both current and new products (including hands-on work).
- Maintain proper documentation of all laboratory activities following GDP standards. Write R&D protocols and reports in support of R&D product development.
- Perform product testing in support of R&D product development.
- Contribute to validation protocols and reports.
- Assist in training of manufacturing personnel at time of design transfer
- Maintain R&D inventory supply and ordering.
- Contribute to optimization and improvements of GMP products.
- 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.
- Provide support to Manufacturing, Quality Assurance and other departments as needed.
- All other tasks as needed or assigned by supervisor
Preferred Experience, Education & Qualifications (Education/Degrees/Certifications)
- Scientist I
- 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.
- Scientist II
- 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.