Research Associate II — 6DA907 : Formulation develop 5100 (19-00679) – MA – Framingham

Duties:
Responsible for the execution and analysis of experiments and analytical procedures. Displays an investigative or technological orientation in designing, executing and interpreting experiments and analytical procedures. Investigates basic technical problems and performs routine scientific procedures and experiments under general supervision.

Plans and prioritizes concurrent experimental procedures. Integrates, complies, and tabulates data and assists supervisor in the analysis and interpretation of the results. May provide oral presentations on results to other department members. Works under active supervision. Follows established procedures. Work is reviewed for soundness of technical judgment and overall adequacy and accuracy.

Contributes to the completion of milestones associated with specific projects. Failure to achieve results or erroneous execution may cause delays in program schedules, and may result in the allocation of additional resources. Frequent internal company contacts. Infrequent inter- departmental and outside constituent contacts on routine matters.

Experience: 3 to 6 years

Biologic Drug Product Development (BDPD) is responsible for the late stage biopharmaceutical formulation/fill finish process development, process scale up, and technology transfers to manufacturing or CMO. This multi-disciplinary team interacts intensively with many functional groups, including early formulation, process development, analytical, regulatory, clinical, and commercial manufacturing, for the pipeline product development. BDPD has also provided technical support for commercial manufacturing, clinical trial material production, manufacturing deviation investigation, process tech transfer/ validation, and regulatory response.

The incumbent will be responsible for preparing buffer and formulation solutions, conducting protein sample analysis using different analytical techniques, including HPLC, Microflow imaging, HIAC, spectrophotometry, NIR, etc.

The associate will be responsible for study design of frozen bulk process development, such as freeze thaw, compatibility, and stability experiments. Experimentation may include scale down modelling of frozen bulk systems. Additional studies may include fill finish process development (e.g. mixing, filtration, effect of fluid flow, and lyophilization). Other responsibilities will include presentation of study results both inside and outside group.

The candidate has to be self-motivated, with three or more years of experience, with a good understanding of protein biochemistry and biophysics.
Source: Job Diva – Job Listing

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