QA Document Control Labeling Specialist

Assistant/Associate Scientist Location: Devens, MA Duration: 06 Months Comments: Candidate will be required to report onsite.

Job Description: Design, execution, and data interpretation of Chromatography and Filtration experiments.

Support process scale-up activities in the pilot plant and clinical and commercial manufacturing sites.

Prepare/review technical documents including process performance qualification reports, tech transfer documents, process characterization reports, and in-process control strategy documents, as well as CMC regulatory submissions.

Participate on cross-functional teams to progress both commercial and late stage drug candidates.

Conceptualize and implement upcoming technologies for biologics manufacturing.

Lab operation experience with AKTA AVANT, depth filtration, Ultrafiltration/Diafiltration preferred.

Knowledge of protein purification, biologics manufacturing preferred.Thanks

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