Viral Therapeutics Manufacturing Manager- Night Shift

United States, Houston (Texas)

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.

Lonza Houston’s Cell and Gene Therapy Facility is the largest in the world and is still growing. We are looking for professionals to grow with us in our Viral Vector production business unit.  The Viral Therapeutics Manufacturing Manager will be responsible for manufacturing operations. He/ she will be part of a team responsible for ensuring cGMP compliance during the production of biological products, assist in the preparation for agency and customer inspections and may represent the manufacturing department on project teams, ensuring that quality requirements are met. Other duties may include conducting cGMP training for new and current employees, participation in internal and external audits as required, reviewing cGMP records, change control, and overall cGMP compliance.

Key Responsibilities:

  • Directs the manufacturing activities.

  • Ensure product is manufactured in accordance with appropriate regulatory agency validation requirements, internal company standards, and current industry practices.

  • Compile and analyzing validation data, preparing reports and making recommendations for changes and/or improvements.

  • Investigate and troubleshooting problems.

  • Review, write, and execute validation production records.

  • Review and modifying standard operating procedures.

  • Coordinate testing, production, validation activities, and personnel.

  • Training/mentoring new hires and transfers within the department.

  • May require 10% domestic and international travel.

Key Requirements:

  • Extensive  experience  in a regulated industry (preferably FDA-regulated biotech/pharmaceutical) with proven management experience.

  • Must have a thorough understanding of regulatory, compliance, and validation issues, as well as experience in writing technical reports and protocols.

  • Must have a thorough knowledge of cGMP requirements.

  • Proficient in the use of spreadsheets, databases, presentation, and word processing software.

  • Must have good documentation skills.

  • Must have strong communication skills, both written and oral, facilitation, and presentation skills.

  • Able to write complex reports without supervision and develop new procedures where needed.

  • Able to clearly communicate problems and observations with management from other departments.

  •  Demonstrated skills in problem-solving and providing solutions.

  • Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines.

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. 

Reference: R41022
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