Primary Role: The individual will support purification process development for diverse therapeutic biologics in the Shire pipeline for both early and late stage product development. The individual will apply basic principles from multiple disciplines as well as industry practice and standards. The candidate must be highly motivated, science driven, and results oriented in a team environment.
60%: Conducts all aspects of downstream process unit operations, including depth filtration, chromatography, TFF, viral inactivation and viral filtration to support process development, optimization and characterization. Activities primarily occur at bench scale. Contributes to the evaluation of new technology/equipment that can be applied across multiple programs.
25%: Documents data accurately in laboratory notebooks as per established company guidelines and procedures. Drafts technical reports, memos, procedures, protocols and presentations.
15%: Organizational support and cross-functional project team participation. Presents to department and at project team meetings.
Education & Experience Requirements:
- MS (0+ years) or BS (2+ years) in Chemical Engineering/Biological Engineering/Biochemistry/Chemistry or related disciplines.
- Fundamental understanding of protein separation theories and practices is required.
- Purification process development experience in the biotechnology and pharmaceutical industry is highly desired.
Key Skills and Competencies: The candidate demonstrates ability to design experiments with DOE approaches, perform experiments and interpret the results. Laboratory skills in downstream process development for biologics are required, including chromatographic and filtration instruments. Knowledge and experience in high throughput screening and automation for process development is preferred. The candidate should be able to work in a fast paced and team-oriented environment with capacity to prioritize accordingly, under guidance, in order to meet program timelines. The candidate demonstrates excellent oral and written communication skills.
Complexity and Problem Solving: The candidate is expected to manage basic projects and apply scientific disciplines, defined protocols, and standard practices and procedures when designing and conducting experiments, under supervision, to solve a variety of problems of moderate scope and complexity.
Internal and External Contacts: The individual will effectively collaborate and communicate within the framework of cross-functional, multi-disciplinary process development teams within Process Development/Technical Services, including cell culture, analytical, formulation and the pilot plant. In addition, this person will interact effectively with other key partners and customers across the company including research, internal manufacturing, external contract manufacturing, facilities/engineering, supply chain, project management, procurement, and quality.
Other Requirements: This position will be based at Shire’s Lexington, Massachusetts facility. The candidate may be asked to travel occasionally (domestically and internationally) for conferences, seminars, and project-specific needs.
Location/Region: Lexington, MA