Sr. Manager, QA Cell Therapy Operations at Lonza Biologics, Inc.
Posted in Science 30+ days ago.
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Location: Portsmouth, New Hampshire
At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.
We strive to be the leading supplier using science and technology to improve the quality of life.
We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
Do you want to help us as we shape the future of this great organization?
Job Description SummaryManage all aspects of QA operations for a Phase III/Commercial GMP Cell Therapy contract manufacturing facility and ensures that manufacturing related GMP systems and controls meet Global Quality standards and applicable regulatory requirements. In addition, this role will liaise with clients on a regular basis to ensure that QA and compliance operations activities meet their expectations
Key Accountabilities and Duties:
Provide leadership and decision making for CT quality operations for manufacturing, testing and quality systems for cell therapy products. Administer oversight for quality decisions with departments within the Lonza network. Provide training for junior quality staff. Lead strategic site projects and alignment for CT.
Minimum Required Qualifications/Skills:
Advanced years biopharmaceutical manufacturing experience and/or quality operations or quality system working in a GMP environment.
Detailed knowledge and understanding of aseptic technique, sterile drug product manufacturing and quality assurance operations. Strong knowledge in the application of cGMP requirements, biomanufacturing processes, and purpose and function of supporting processes.
Effectively presents information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding. Able to communicate status, needs, forecasts, risks and timelines effectively to management. Displays a clear willingness to listen to others. Has good interpersonal skills and works interdepartmentally in an effective manner to achieve objectives. Shows commitment and dedication and strives to be ahead of schedule. Is not afraid to make decisions for the group. Practices safety awareness at all times and considers impact of actions prior to executing activities.
EducationBachelors: Biology (Required)
Work ExperienceQuality (Advanced)
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
Lonza. The place to Go, Stay and Grow.