Research Associate I/II - Viral Vaccines
RESEARCH ASSOCIATE I-II
Position Summary & Role
The research associate 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 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 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)
- Research Associate I
- BS degree in microbiology, biology, molecular biology, biochemistry, chemistry, or related field and 0-3 years of experience in laboratory sciences/biotech/biopharma. M.S. in same areas.
- Research Associate II
- BS degree in microbiology, biology, molecular biology, biochemistry, chemistry, or related field and 2+ years of experience in laboratory sciences/biotech/biopharma. M.S. 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