Shire Senior Upstream Development Engineer in Lexington, Massachusetts
This position is responsible for applying QbD principles and scientific knowledge to develop efficient and robust upstream manufacturing processes and establish product and process knowledge. Accountable for timely completion and successful transfer of the processes to either internal or external manufacturing partners. Works and communicates well in multi-disciplinary environments and works without appreciable direction. Exercises considerable latitude in determining assignment objectives. Involved in a wide range of complex problems, requiring the regular use of ingenuity and creativity. In addition, this position will contribute to establishing the infrastructure and business processes in support of process development from discovery through commercial launch.
Job Function and Description
Provide technical expertise and leadership in planning, designing, and conducting experiments and analyzing data toward development and optimization of cell culture processes that are in line with overall project plan and milestones.
Manage, monitor, and troubleshoot bench-top bioreactors and related control systems.
Responsible for documentation and maintenance of experimental data, and generating high quality written study proposals, development reports, and oral presentations.
Maintain substantial knowledge of state-of-the-art principles and theories and contribute to BioEngineering scientific knowledge base through literature review, conference attendance, and publication.
Lead evaluation of technologies new to Shire in their potential application.
- Participate or lead upstream process development team, participate drug substance team and other departmental sub teams. Contribute to team meetings, including sub teams, project teams, tech. transfer teams, and departmental meetings.
Education and Experience Requirements
Degree in Chemical Engineering, Biochemical Engineering or other related discipline with minimum years of relevant industry experiences in process development.
PhD: 0-3 years
MS: 3-6 years
BS: 6-9 years
Proven record of technical expertise and troubleshooting. Proven ability to work in a fast-paced environment with demonstrated capacity to juggle multiple competing tasks and demands.
Preferred qualification: Ph.D. in engineering or biological sciences with cell culture process development experience.
Key Skills, Abilities, and Competencies
Have solid understanding of mammalian cell culture process development, process scale-up, tech. transfer, and GMP manufacturing support.
Have experience in design-of-experiment and the ability to analyze and interpret data collected.
Embrace and demonstrate teamwork/collaboration and the ability to communicate appropriately and effectively in both oral and written format.
Demonstrate personal ownership in executing bioreactor process development, tech. transfer, and manufacturing support.
Be customer-focused, results-oriented, science-driven, and embrace Shire’s values.
Have the ability to proactively learn new technologies and mange changes in bioreactor process development and process scale-up.
Have experience working in a GMP environment.
Complexity and Problem Solving
Lead cell culture process development, scale-up, and technology transfer activities. Identify and analyze technical problems and then find and implement solutions.
Apply fundamental engineering and biological principles to practical technical challenges.
Independently plan, design, execute, and analyze experimental data and provide succinct conclusions and/or recommendations.
Work closely with his/her supervisor and coworkers in managing multiple work streams and projects. Make sound and timely decisions based on project priorities. Provide expert input to the Upstream Development group in addition to Departmental sub teams.
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.