Gallus BioPharmaceuticals, LLC (Gallus), a premier pure-play biologics contract manufacturing organization (CMO) announces the appointment of Claudette Kile as Vice President of Quality & Regulatory. This addition to the highly experienced Gallus leadership team supports the continued growth of Gallus’ contract manufacturing services.
Ms. Kile will be responsible for the planning, implementation and daily operations of the Quality & Regulatory organization at Gallus headquarters in St. Louis and the Princeton, New Jersey facility. “Gallus has a strong track record in process development, clinical and commercial manufacturing of licensed biopharmaceuticals at both sites, and the addition of Claudette Kile to our team strengthens our commitment to maintaining exemplary compliance for our pharma and biotech clients as their products mature through the clinic towards licensure,” stated Mark Bamforth, President and Chief Executive Officer of Gallus.
Ms. Kile brings 27 years’ of industry experience in medical devices, biologics, and pharmaceuticals, with specialized expertise in building global compliant quality systems. She has experience with all phases of clinical trials and strong leadership, risk-based decision making, flexibility, compliance, project management, and organizational skills.
Most recently, Ms. Kile was Senior Director of Quality at Jazz Pharmaceuticals where she led the oversight of global clinical trials and drug safety and pharmacovigilance activities. Previous roles in Quality include; Director, Quality Assurance at Emergent Biosolutions, where she oversaw the supply of vaccines and antibody therapy products from pre-clinical through commercial and managing her own consultancy focusing on regulatory affairs, compliance, and quality assurance. Earlier in her career, Ms. Kile held roles with increasing responsibility at Abbott Labs, as Director, Global Clinical Quality, EV3, Inc. (now part of Covidien) and an extended period at Guidant where she managed 4 clinical departments and had a variety of hands-on quality roles.
About Gallus BioPharmaceuticals:
Gallus BioPharmaceuticals is a leading contract manufacturing company offering exceptional contract services to its clients. Gallus’ world-class facility in St. Louis is distinguished by nearly three decades of biologics development and over a decade of commercial cGMP manufacturing, including the ongoing manufacture of Stelara® and Remicade® for Janssen Pharmaceuticals. Gallus’ facility in Princeton, New Jersey, has three decades of experience in process development and clinical manufacturing of bulk and aseptic-filling of mAbs, as well as large and complex proteins such as Fc-fusion proteins, IgMs, and collagens, plus over 15 years of experience in commercial manufacture of ProstaScint®. Both sites maintain exemplary quality and regulatory records.
For additional information visit http://www.gallusbiopharma.com or email info (at) gallusbiopharma (dot) com.
Gallus BioPharmaceuticals, LLC
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