The individual will be a member within a group responsible for performing purification process development, including timely completion of small-scale experiments and process scale-up for programs that bring new biopharmaceutical products to pre-clinical, clinical and process validation manufacturing phases. The individual applies basic knowledge form various technical areas, industry practices and standards under close supervision. Provides quality and productive output that is consistently timely, reliable and reproducible. The candidate must be customer focused, results oriented, science driven and embrace Shire’s values.
Experimentation work related to protein purification, including laboratory and pilot plant scale studies (chromatography and filtration unit operations) to support process development, optimization and characterization. Contributes to the evaluation of novel, generic platform technologies that can be applied across multiple programs. Executes IND- and BLA-enabling studies
Documents data accurately in laboratory notebooks as per established company guidelines and procedures. Drafts technical reports, memos and presentations. Contributes to CMC sections of regulatory submissions. Assists with external abstracts, presentations and publications.
Organizational support and cross-functional project team participation.
Education & Experience Requirements:
BS (0-2 years) in Chemical/Biochemical Engineering, Biochemistry or related discipline. Product and purification process development experience in the biotechnology/pharmaceutical industry is preferred. Familiarity with the operation of purification equipment for chromatographic and filtration unit operations is desired.
Key Skills, Abilities, and Competencies:
Should have basic knowledge of experimental design and the ability to interpret the data collected. Familiarity with cell culture and the analytical characterization of proteins (e.g. SDS PAGE, HPLC, ELISA) is desired. Proficient with standard computer applications. The person will be expected to display sense of urgency while completing critical tasks and effectively manage his/her time. Should be able to work in a fast paced environment with capacity to prioritize accordingly under close supervisor’s guidance, in order to meet program timelines. Systematically seeks supervisor guidance. Keeps current with literature in the area of separations.
This position will be within Shire HGT’s Massachusetts operations (Lexington). The candidate may be asked to travel occasionally (domestically and internationally) for conferences, seminars, and project specific needs.
Location/Region: Lexington, MA