Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
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.
The BioLife Process expert is responsible for providing expertise and support for the BioLife operations related to all products. He/ She will coordinate innovation and continuous improvement programs in coordination with BioLife and key stakeholders. Additionally this person will ensure Knowledge Management is captured and shared across the different functions, and will serve as a liaison to plasma collection to ensure plasma meets manufacturing requirements. He/ She is in close contact with the BioLife collection/ quality organizations, with strategy organizations and with relevant process experts.
Execute, coordinate and support programs to drive yield improvement projects, to secure the plasma collection process and to reduce variability and deviations.
Drive Yield projects identification, scoping, prioritization, tracking and reporting.
Supports evaluation of proposed collection changes for their impact on the downstream manufacturing processes.
Responsible to provide a reliable yield status and accurate yield forecasts based on plasma type.
- Ability to manage activities of departments in a matrix environment through managers who exercise full supervision in terms of cost, methods, and employees
- Ability to interpret and analyze statistical data and financialreports
- Understand and resolve project and technical difficulties, interface with internal engineering/ technical experts, and manage multiple priorities in a manufacturing environment setting.
- Knowledge about plasma biochemistry, collection and fractionation are required
- High level of customer orientation and organizational skills
- Flexible in mind / out of the box thinker
- Enthusiastic, decisive, motivating and convincing personality
- International background appreciated
- Excellent communication skills, verbal and written communication skills
- Excellent English skills; German, French, Italian is beneficial
BS in a relevant scientific discipline (Biochemistry, biotechnology or pharmacy), advanced degreepreferred. Minimum of 6years experience in pharmaceutical or biotechnology, preferably in plasma collection and/or fractionation.
Req ID: R0020419