Shire Upstream Development Engineer in Lexington, Massachusetts
The individual will be a member within a group responsible for performing upstream process development, including timely completion of small-scale experiments, scale-up, technology transfer and GMP floor support for programs that bring new biopharmaceutical products to pre-clinical, clinical and process validation manufacturing phases. Scope of work includes cell banking, cell expansion, bioreactor process, and harvest clarification process development, optimization, characterization, scale-up, and technology transfer to CMO’s and/or internal manufacturing facilities. The individual applies basic knowledge from various technical areas, industry standards and practices, provides quality and productive output that is consistently timely, reliable and reproducible. The candidate must be customer focused, results oriented, science driven and embrace Shire’s values.
60%: Provide technical support and apply knowledge and execute experiments toward development and optimization of cell culture processes and in line with overall project plan and milestones under close supervision. Manage, operate, monitor, and troubleshoot bench-top bioreactors and related control systems, design and oversight of GMP, engineering and pre-clinical batches. Interacts with manufacturing operations staff, participates during troubleshooting of issues. Executes IND-and BLA-enabling studies.
25%: Documents data accurately in laboratory notebooks as per established company guidelines and procedures. Drafts technical reports, memos, procedures, technology transfer packages and presentations. Contributes to CMC sections of regulatory submissions. Assists with external abstracts, presentations and publications.
15%: Participate in and contribute to team meetings, including sub-teams, project teams, tech. transfer teams, and departmental meetings.
Education and Experience Requirements
MS (0-2 years) or BS (2+ years) in Chemical/Biochemical Engineering/Biological Sciences or related discipline with relevant industry experience in upstream process development. Proven record of technical proficiency and troubleshooting. Proven ability to work in a fast-paced environment with demonstrated capacity to juggle multiple competing tasks and demands.
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.