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 GMP on-floor support for programs that bring new biopharmaceutical products to pre-clinical, clinical and commercial manufacturing phases. The candidate will primarily be responsible for directing development and supporting clinical manufacturing activities at contract manufacturing organizations (CMOs) and contract research organizations (CROs), including troubleshooting manufacturing issues, analyzing data and authoring technical reports and memos. Experience with business operations and program management is desired. The individual will work autonomously to implement solutions for problems of moderate scope and complexity under general supervision. The candidate will apply standard methodologies, practices and procedures in order to provide input during development of new processes and techniques that provide Shire with competitive advantage.
The candidate will design experiments for purification process development, optimization and characterization studies for therapeutic proteins. The scope includes IND- and BLA-enabling studies and contributions to the 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 effectively collaborate and communicate within the framework of cross-functional, multi-disciplinary process development teams. In addition the candidate will interact with other departments such as research, internal manufacturing, external contract manufacturing, facilities/engineering, supply chain, project management, procurement and quality.
Education and Experience Requirements
PhD (2+ years) or MS (5+ years) or BS (7+ years) in Chemical Engineering, BiochemicalEngineering, Chemistry, Biochemistry, Biology or related discipline with relevant industry experience.
Technical expert in the field of separations, including small-scale process development and optimization, scale-up, tech transfer and manufacturing support to large scale GMP operations. Advanced understanding of scientific theories, concepts, principles, experimental techniques and industry practices and standards. Keeps current with latest literature and technologies.
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.
Professional experience working contract organizations
Key Skills, Abilities, and Competencies
The candidate must be customer focused, results oriented, science driven and embrace Shire’s values. Designs technical strategies to fulfill assignments under the general guidance of supervisor. Also refers to procedures, policies and practices for additional input. Must have experience in design of experiment, statistical analysis and the ability to interpret data collected and derive appropriate conclusions. Authors high quality technical reports and presentations for management and peers. Contributes to publications and to the preparation of CMC sections of regulatory filings. Familiarity with cell culture and the analytical characterization of proteins (e.g. HPLC, ELISA, etc.) is desired.
Complexity and Problem Solving
This person 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 management oversight. The person will be expected to display sense of urgency while completing critical tasks and effectively manage his 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
The candidate must demonstrate effective written and verbal communication skills, including excellent documentation skills. Successfully conveys complex information from multiple sources in both written and oral forms. Individual will work closely and communicate frequently with supervisor and peers. Works autonomously and receives general instructions on new assignments. 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 and symposiums.
She/he interacts with internal stakeholders within purification as well as other process development groups such as cell culture, analytical, formulation and the pilot plant. 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, external contract manufacturing, facilities/engineering, supply chain, project management, procurement and quality. Individual will also work with external vendors. Acts as departmental team leader or interdepartmental project team participant. Interacts, communicates and influences decisions across multifunctional areas and platforms. May act as team or project representative on external collaborations and with contract laboratories. Networks externally with industry peers.
Other Job Requirements
This position will be within Shire HGT’s Massachusetts operations (Lexington). The candidate may be asked to travel occasionally (domestically and internationally) for project specific needs (on-floor support at contract organizations), conferences and seminars.
Req ID: R0012005