The individual will be a member within a group responsible for performing purification process development, including timely completion of small-scale experiments, scale-up, technology transfer and GMP floor support for programs that bring new biopharmaceutical products to pre-clinical, clinical and process validation manufacturing phases. The individual applies basic knowledge from various technical areas, industry standards and practices. 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.
60%: Experimentation and manufacturing support work related to protein purification, including laboratory and 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. Participates during technology transfer of programs spanning all phases of biopharmaceutical lifecycle, including discussions of scale, equipment, design and oversight of GMP, engineering and pre-clinical batches. Interacts with manufacturing operations staff, participates during troubleshooting of issues. Executes IND-and BLA-enabling studies.
25%: Documents data accurately in laboratory notebooks as per established company guidelines and procedures. Drafts technical reports, memos, procedures, technology transfer packages and presentations. Contributes to CMC sections of regulatory submissions. Assists with external abstracts, presentations and publications.
15%: Participate in and contribute to team meetings, including sub-teams, project teams, tech. transfer teams, and departmental meetings.
Education & Experience Requirements:
MS (0-2 years) or BS (2+ years) in Chemical/Biochemical Engineering or related discipline with relevant industry experience. Product and purification process development experience in the biotechnology/pharmaceutical industry with practical experience around scale-up, technology transfer and manufacturing support of large scale GMP operations is desired. Familiarity with the operation of large scale purification equipment for chromatographic and filtration unit operations is desired. Engineering degree preferred. Keeps current with literature and latest technology developments, particularly in the area of separations.
Key Skills and Competencies:
Should have knowledge of experimental design and the ability to assimilate and interpret 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 supervisor’s guidance, in order to meet program timelines.
Complexity and Problem Solving:
• Technical decisions on major investigations and continuous improvement initiatives
• This person may act as a technical resource within the department to more junior staff during scale-up and technology transfer of purification processes. May lead team members on project assignments. The candidate will be expected to manage basic projects. Applies defined protocols, standard practices and procedures when conducting and designing experiments, under close supervision, to solve a variety of problems of moderate scope and complexity. May provide input during design and development of new processes and techniques that gives Shire competitive advantage.
Internal and External Contacts:
The candidate should have good communication, interpersonal and organizational skills (written and verbal). May coordinate information across groups. Individual communicates effectively and frequently with supervisor and peers. Works closely with supervisor for guidance, soundness of technical judgment, result adequacy and accuracy. Presents to departments and project team meetings.