Associate Director, Viral Vector Manufacturing (Biotech)
Today, Lonza is a global leader in life sciences operating across five 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.
Lonza Cell and Gene Therapy Facility is the largest in the world and our facility is growing. We are looking for professionals to grow with us and we have this exciting opportunity in Viral Vector Therapy https://pharma.lonza.com/offerings/cell-and-gene-therapies/viral-vector-gene-therapy. The Associate Director will be responsible for ensuring the successful execution of technical support for customer's and company's processes in order to meet established timelines and quality objectives. This individual will demonstrate role model behavior with regards to safety standards, ensuring all activities are performed according to the safety practices and approved procedures per cGMPs regulations. The qualified candidate will be responsible of leading, mentoring and coaching Viral Vector individuals in order to create the environment for a high performing team.
Key Responsibilities:
Accountable of the adherence to safety and cGMP regulations of the team.
Ensures planning adherence of daily activities in the clean room and provide second line of problem solving in case of any event.
Accountable of the maintenance of the material stock needed in production areas.
Provides coaching and mentoring in the technical and managerial topics.
Assist senior staff to support Manufacturing and customer through process and process equipment troubleshooting.
Escalation to high management and interaction with other stakeholders in case of any event (Deviation Investigation Team, QA, MSAT, FE, etc.).
Contributor or leader on MFG and OE projects to optimize and streamline processes.
Assists with evaluation of process requirements to ensure facility and equipment capability design.
Assess new proposals from prospective customers.
Responsible to interact with customer regarding operations performance.
Reviews and approves Batch Records, Change Controls, Deviations and other documentation required for production operations.
SME during audits for all activities performed in the area.
Key Requirements:
Bachelor's Degree in Biotechnology, Biology, Chemistry, or equivalent with Associates degree
Highly experienced working in a cGMP Manufacturing Environment
Understands how to effectively engage others in the change processes.
Understands and explains the corporate strategy to his/her peers and team.
Provides feedback to his/her managers on the content of the strategy and its implementation.
Sets and delivers on individual and team objectives that support the company strategy.
Uses knowledge of his/her area business area and related areas to make correct and timely decisions.
Works in partnership as an active member of the team and cross-functional groups.
Generously shares information and knowledge with others across the team.
Actively seeks out and shares different perspectives from a broad network and implements alternative approaches.
Identifies when company and customer interests may not align and seeks effective solutions to escalate.
Manages internal and external customer relations professionally and effectively.
Uses systematic approaches to ensure customer key metrics and tracked and analyzed for continuous improvement.
Establishes and consistently delivers on KPIs and challenging foals for him/herself and the team.
Helps peers and team overcome performance challenges.
Secures buy-in from key stakeholders
Ensures delivery excellence for own goals and the team.
Regularly solicits, assesses and addresses feedback.
Develops budgets and resource plans.
Appropriately prioritizes and leads activities in the clean room.
Supports others in takin responsibility for a safe and sustainable environment.
Seeks and provides feedback to their team to support professional development.
Takes personal accountability for defining and implementing own development as supports others to do same.
Creates a positive work environment and demonstrates high integrity.
Ensures clear and direct 2-way communication with the rest of Core Techs.
Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
In depth knowledge of pharmaceutical manufacturing, safe work environment leadership, delivery of RFT, and leadership and development of leadership teams delivering progressive continuous improvement in a multi-layered organization.
Expert Level knowledge of cGMP facilities and cGMP requirements and API.
Expert Level experience in biomanufacturing; GMP setting required.
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.
