Director, Tissue Acquisition (Biotech)
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.
The Director, Tissue Acquisition creates strategy, plans operations and directs personnel of Tissue Acquisition to ensure the adequate and appropriate supply of tissues to support Cell & Gene Therapy (C>) contracts and Bioscience operations and projects. Leads Tissue Acquisition teams, plans development and management of tissue vendors, works in cross-functional Lonza teams to ensure that regulatory, ethical and business requirements are met while supporting C> and Bioscience customers and businesses worldwide.
Key responsibilities:
Lead Tissue Acquisition personnel, plans and operations. Manage, mentor and train direct reports. Responsible for key metrics and for driving process improvements utilizing data.
Establish guidelines and principles under which human tissue is sought, collected, and provided to Lonza for research and therapeutic use. Understand, train personnel, and follow AATB Standards.
Identify, establish, monitor tissue sources and agreements;support training efforts, maintain regular contact, update contracts. Develop new tissue sources to meet production, balance research and customer needs.
Ensure that donor programs for C> are operating within or exceeding regulatory standards; support donor program operations, promote their growth based on client project requests and contract manufacturing requirements.
Hold responsible positions for tissue bank state licenses or permits, professional organization (AATB) leadership accreditation requirements, and as Principal Investigator for Institutional Review Board (IRB) applications and approvals. Serve as the primary Human Protections Administrator (HPA), if
needed, and will maintain training and certification under the requirements of the Office of Human Research Protections (OHRP) and other associated regulatory agencies.
Participate on a national level to contribute scientific expertise to tissue banking standards and rules. With Lonza regulatory affairs personnel, provide recommendations for donor screening & testing, tissue recovery, donation permission, IRB oversight, ethical principles for C> clients to support their regulatory filings and decisions across the globe.
Perform other duties as assigned.
Key requirements:
Knowledge of transplantation field and related subjects in human medicine, GMP/GTP rules and regulations governing human tissue, cell biology including cell culture techniques and laboratory assays.
Solves complex problems requiring analysis of situations and data.
Ability to plan and manage multiple projects.
Exercises judgment using ethical basis within broadly defined practices.
Applies strong analytical and problem-solving skills to complex issues.
Excellent written and verbal communication skills.
Organizational and management skills including planning, mentoring, coaching, training, team building.
Diplomacy, negotiation skills, independent work skills, strong work ethic.
Independent thinker with innovative ideas, adaptability for change.
Excellent team player and leader.
Professional, knowledgeable, diplomatic, and sincere.
Pleasant, energetic, engaging demeanor who can meet and communicate clearly with people at any level and situation.
Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
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.
