The individual will be expected to monitor and provide support for manufacturing cell culture/purification operations. Responsibilities will include monitoring of the process and containment of process failures and deviations that occur during cell culture/purification processes and coordination of implementation of associated corrective and preventative actions. The individual will also participate and function as PTS lead on technology transfer and process improvement teams. Leadership and guidance of junior staff members in certain situations will also be expected.
Floor Support - Troubleshoot process issues; monitor and evaluate process operation data for upstream or downstream operations including but not limited to cell culture roller bottle/bioreactor and capture step operations, filtration (NF, UF/DF) unit operations, chromatography column performance/integrity and drug substance formulation/bottling.
Tech Transfer - Support the transfer of phase I, II/III clinical processes into the existing GMP manufacturing facilities as define by Tech Transfer group
Continuous Improvement - Work with manufacturing staff to identify opportunities to improve the consistency and robustness of process operations. Provide leadership in the development of mfg. training initiatives.
Quality System Support - Lead consistent and well documented response to process operations events to support investigations, deviation closure as well assistance to change control/CAPA as appropriate.
Education & Experience Requirements:
BS in Chemical/Biochemical Engineering or Chemistry with 8 to 12 years or MS with 6 to 10 years of process development / manufacturing experience for purification of recombinant proteins.
Hands-on experience with large-scale cell culture/purification manufacturing processes, preferably with commercial or licensed products. A working familiarity with single use process systems, automation (local and distributed control systems), and sterile/aseptic processing in a cGMP environment. A detailed knowledge of the science and technology for the major unit operations associated with manufacturing operations to include mammalian cell culture, bioreactors, fluid transfer, filtration, chromatography, CIP/SIP, and UF/DF processes. Experience with troubleshooting / problem solving and risk assessment / mitigation. Demonstrated experience making science based and/or data-driven recommendations for manufacturing operations. Experience with process / technology transfers. Prior supervisory / management experience is a plus.
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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A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.