Senior Biotech Engineer
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 is establishing a strategic biomanufacturing base in China using GE Healthcare Solutions. With the new facility, Lonza is responding to growing demand for a high-quality CDMO in the Chinese market. The two companies will work closely on the design of the 17,000 m2 site, which will include 6,500 m2 of lab space and one KUBio facility. With more than 20 successful FDA approvals for biologics, combined with international regulatory expertise, Lonza will now be able to offer the same high standards in China as it does elsewhere. Lonza plans to hire and train a significant number of staff for this site.
- Responsible for providing leadership and oversight to all routine operational and administrative activities which occur within the individual’s team.
- Display superior process understanding & equipment troubleshooting ability under both routine & non-routine scenarios
- Maintain currency of knowledge in emerging and advances of technologies
- Attain subject matter expertise in ≥ 2 areas of manufacturing operations e.g. USP: Media Preparation & Primary Recovery, DSP: Column Packing & Bottling, SUP: Buffer Preparation & Dispensing,
- Attain 100% trainer qualifications in identified areas of specialization
- Able to assimilate quickly to leadership roles in other process areas outside of areas of specialization
- Participate in Customer & Regulatory Audits
- Follow through to completion Quality Tag-outs, Change Requests, Planned Deviations and/or Computer Systems Change Controls (CSCCs)
- Recognized as a DELTAV system expert and competent in addressing and/ or reviewing Minor/ Major Deviations
- Make real-time non-critical decisions on operational issues based on superior knowledge of defined SOPs & policies
- Review more critical/ complex decisions with Manufacturing Management and/ or other support functions
- Able to identify suite problems, troubleshoot, identify & complete or coordinate corrective action
- Provide formal peer review to Snr/ Section Lead and Section Manager
- Provide active mentoring/ coaching to Biotechnologists.
- Plan and prioritize suite activities/ resource loading on a 2-week look-ahead of production schedule
- Excellent coordination skill between departments for multiple parallel activities
- Able to communicate manufacturing operations perspective effectively to management.
- Highly motivated and is regarded as an upcoming leader both technically and in soft skills
- Direct day-to-day manufacturing activities of team as required by Snr/ Section Lead and Section Manager
- Able to manage multiple priorities and is recognized by colleagues as a source of expertise
- Able to support MSAT, Lot Review and Deviation Investigation groups when situation calls for it
- Act as responsible suite designee during technology transfers
- Create & present training materials/ seminars on technical/ cGMP issues
- Involved routinely in OE improvement projects and make recommendations to improve manufacturing processes
- Own & lead process improvements projects (often complex in nature) in collaboration with MSAT/ Engineering
- Have cell culture working experience in a biologics industry
- Degree/Diploma in a related Science/Engineering discipline
- Demonstrate commitment to cGMP, EHS compliance aspects of clean-room and production operation
- Strong knowledge of Biopharmaceutical processing is an added asset
- Excellent Knowledge of cGMP applications
- Positive team oriented attitude
- Good communication skills
- Demonstrate leadership skills
- Willing to perform rotating 12-hour shift pattern
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.