R&D Associate I- Upstream Process Development
GENERAL SUMMARY OF POSITION:
The Research Associate I is responsible for carrying out upstream cell culture process development activities supporting development of media and feed supplements, optimization and scale-up of cell culture processes for the production of monoclonal antibodies and technical transfer to manufacturing. The Associate I will prepare, formulate, and filter cell culture basal media and reagents. Additionally, the Associate I will provide lab coverage during evenings, weekends, and holidays on a rotating basis, as required to support upstream development activities. The incumbent will perform established assays and contribute to the development of new assays.Responsibilities
- Maintains cell cultures in monolayer, shake flask, spinner flask and small-scale bench top bioreactor systems for the production of monoclonal antibodies.
- Prepare experiments and maintain cell culture logs as required.
- Performs analytical biochemistry and molecular biology assays as well as microscopy and other laboratory testing as required.
- Keeps timely and accurate documentation records in notebooks, organize and report results.
- Operates and maintains standard laboratory equipment and departmental specific laboratory equipment.
- Analyzes data in Excel and DOE software, and provides accurate, concise data summaries
- Ensures timely and accurate documentation in accordance with cGMP and MassBiologics' SOPs. Contributes to the development of improved documentation processes.
- Provides support for protocol writing, project summaries and technical reports.
- Prepares written and oral reports for presentation to the supervisor(s) and development group.
- Maintains reagent and equipment inventories, orders supplies and cleans laboratory areas, hoods and common equipment.
- Exercises technical discretion in the design, execution and interpretation of experiments that contribute to project strategies within defined parameters.
- Perform additional job related duties as required.
- Requires a bachelor’s degree in Chemistry, Biochemistry, or related field with a minimum 0-2 years of relevant experience.
- Hands on experience with antibody production in mammalian.
- Ability to follow instructions precisely, recognize deviations, and recommend corrective action within scope of training.
- Possesses strong attention to detail, ability to maintain accurate records and excellent proofreading skills.
- Ability to troubleshoot within scope of training.
- Strong critical thinking, time management and organizational skills. Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines.
- Excellent written and verbal communication skills. Ability to communicate effectively with others.
- Ability to work effectively both independently and as a member of a team.
- Computer literate and proficient in MS Word, Excel and other relevant electronic systems.
- Occasionally projects require flexibility in work schedule to meet business needs.
ENVIRONMENTAL WORKING CONDITIONS:
Job may require working with hazardous and infectious materials. Employees will receive appropriate training and be required to adhere to UMBL policies and procedures.