As a key member Lexington process lab, part of the PDTS (Process Development and Technical Services) organization this individual is responsible for providing product lifecycle management and manufacturing support for the global Biologics network. The scope of the experimental work includes studies in support of process improvement ideas that will be implemented globally and are part of the project portfolio plan for the local Lexington or any other global facility. In addition the scope includes experimental work needed for manufacturing support , like supportive work for CAPA investigations and change control. Responsible for developing, qualifying, and maintaining a scale-down model for specific Biologics processes with at least one scale down factor. Leading continuous process improvements, aimed at improving robustness, capacity, and productivity, as per Shire's QbD paradigm. This position will be leading and mentoring junior staff as an in-line or matrix leader.
Planning, designing and conducting experiments, analyzing data and documenting results towards continuous upstream process improvement, including reducing recurring deviations, and increasing level of safety and/or compliance
Planning, designing and conducting experiments, analyzing data and documenting results in trouble-shooting and root cause analysis for process discrepancies and quality investigations of complex technical nature
Develop, qualify, and maintain scale down models with at least one scale down factor.
Review and approve data from local scale down model (SDM) and assure SDM compliance with SDM qualification handbook
Plan and coordination of day-to-day activities of the laboratory. Provide input on scheduling and and utilization of the lab. Maintain equipment and utilities/lab services.
Liaise with local Technical Services (TS) teams during investigations to provide study design
Liaise with Process development (PD) for Tech transfer and Development support
Liaise with QC and AD testing support function for data acquisition
Deliver high quality written study proposals, research and development reports, and investigation reports
Education & Experience Requirements:
Minimum Degree Required: BS in a scientific or engineering discipline
Preferred Degree: PhD in a scientific or engineering discipline
Certificate(s): Lean or Six Sigma certification preffered
Experience: At least 8 years professional experience in the Biotechnology or Pharmaceutical industry (4 years with a PhD, 6 years with an MS, 8 with BS ). At least 2 of those years should be with supervisory experience. Experience working in a laboratory is a must.
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.
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Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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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.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.