The candidate will be a key contributor within a group responsible for performing purification process development, including small-scale experiments, scale-up, technology transfer and support for programs that bring new biopharmaceutical products to pre-clinical, clinical and commercial manufacturing phases. The successful candidate will be a leading contributor during execution of purification activities for the department, including troubleshooting problems, analyzing data and authoring technical reports and memos.
The candidate will design and carry out experiments for purification process development, optimization and characterization studies for therapeutic proteins. The scope includes IND- and BLA-enabling studies and preparation of regulatory submissions. The experimental studies involve both lab scale and pilot plant runs, including, but not limited to toxicology, clinical and validation batches. The individual will seamlessly collaborate and communicate within the framework of cross-functional, multi-disciplinary process development teams. In addition, the candidate will interact extensively with other departments such as research, internal manufacturing, external contract manufacturing, facilities/engineering, supply chain, project management, procurement and quality.
The individual will work autonomously to discover solutions for problems of broad scope and complexity under general guidance. The candidate will contribute to the development of novel processes and techniques that provide Shire with competitive advantage. In addition, the candidate is expected to exercise sound judgment to leverage established practices and lessons learned from difficult experiences, leading to best practices and procedures.
35%: Experimentation and manufacturing support related work including laboratory and pilot scale studies 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, troubleshoots problems and supports their operations.
25%: Writing and reviewing of data summaries, technical reports, tech transfer packages, regulatory submissions and presentations.
20%: Organizational support and cross-functional project team participation. Advises management on goals and project direction.
20%: Provides guidance on design of experiments, data analysis and derivation of appropriate conclusions to junior staff.
Education and Experience Requirements
PhD (5+ years), MS (8+ years) or BS (10+ years) in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, Biology or related discipline with relevant product and process development experience in the biotechnology/pharmaceutical industry.
Technical expert in the field of separations, including small-scale process development and optimization, scale-up, tech transfer and manufacturing support to large scale operations. Advanced understanding of scientific theories, concepts, experimental techniques and industry practices and standards. Keeps current with latest literature and technologies. Proven record of technical leadership, including the ability to motivate and influence technical rigor.
Proven ability to work in a fast paced environment with demonstrated capacity to juggle multiple competing tasks and prioritize accordingly to meet program timelines. Uses project leadership skills to drive the planning and management of risks, priorities and contingencies.
Key Skills, Abilities, and Competencies
The candidate must be science driven, result oriented, customer focused and embrace Shire's values. This person must have extensive knowledge and experience on phase-appropriate purification process development and associated unit operations, including chromatography, filtration, etc. Working experience with high through screening using robotic system (e.g., Tecan liquid handling system) is preferred. Familiarity with cell culture processes and analytical characterization of proteins is preferred.
The candidate must have solid experience in design of experiments, process monitoring, process risk assessment, statistical analysis and the ability of interpreting data and deriving conclusions. Designs technical strategies to fulfill assignments under general guidance. The candidate must demonstrate excellent written and verbal communication skills. Contributes to the preparation of CMC sections of regulatory filings. Authors and reviews high quality technical reports and presentations for management and peers. Independently refers to procedures, policies and practices for guidance. Contributes to publications in the field of expertise. Working experience with process simulation is preferred and knowledge of cGMP manufacturing is required.
Complexity and Problem Solving
The candidate will lead small scale development, scale-up and technology transfer of purification processes. The candidate will be expected to design, carry out and lead experimental and theoretical studies under general oversight. The person will be expected to display sense of urgency while completing critical tasks and effectively manage his/her time. The candidate will also be expected to provide original solutions to complex problems while attaining a good balance between theoretical, experimental and practical approaches. Provides expert input for project design and development. Makes sound and timely decisions based on functional priorities.
Internal and External Contacts
Individual will work closely with all internal stakeholders within purification as well as other process development groups such as cell culture, analytical, formulation, pilot plant, etc. There is also the need for company-wide, cross-functional interactions with key partners and customers that include other departments such as research, internal manufacturing, facilities/engineering, supply chain, project management, procurement and quality. Individual will also work with external vendors, including contract manufacturing organizations.
Effective communication, interpersonal and organizational skills are required. Successfully conveys very complex information from multiple sources in both written and oral forms. Proposes technical strategies and frequently discusses soundness of technical judgment and progress to meet objectives and timelines with supervisor and peers. Presents to department, project team meetings, management and external conferences / symposiums.
Acts as departmental or inter-departmental project team lead. Fosters interactions, communicates and influences decisions across multifunctional areas and platforms. Acts as team member or lead contact on external collaborations and with contract laboratories. Networks externally with industry peers.
Other Job Requirements
This position will be within Shire's Massachusetts operations (Lexington). The candidate may be asked to travel occasionally (domestically and internationally) for conferences, seminars, and project specific needs
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.