Shire Senior Downstream Development Engineer in Lexington, Massachusetts
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 is expected to contribute during execution of process engineering activities for the department, including troubleshooting manufacturing issues, analyzing data and authoring technical reports and memos. 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 and carry out 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.
≤60%: Experimentation and manufacturing support related work including laboratory and pilot 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, troubleshoots problems and supports their operations.
≤25%: Writing and reviewing data summaries as per established company guidelines and procedures. Authors technical reports, technology transfer packages and presentations. Contributes to regulatory submissions.
≤15%: Organizational support and cross-functional project team participation.
Education and Experience Requirements
PhD (0-3 years) or MS (3+ years) or BS (5+ years) in Chemical Engineering, Biochemical Engineering, 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.
Key Skills, Abilities & 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. Working experience with high through screening using robotic system (e.g., Tecan liquid handling system) is preferred.
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 conferences, seminars, and project specific needs.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.