Lead Scientist, Purification Development

Lonza; United States; On-site; USD 80,000 - 100,000; Full time

Job summary

Join a forward-thinking company as a Lead Scientist, where you will play a pivotal role in designing and implementing virus clearance studies essential for regulatory compliance in biopharmaceuticals. This position offers the unique opportunity to work closely with global clients and various functions within the organization, ensuring high-quality communication and project delivery. You will lead a talented team, tackle complex challenges in life sciences, and contribute to the development of innovative treatments that improve lives worldwide. This role is perfect for those passionate about science and eager to make a significant impact in the industry.

Qualifications

• 4-7 years of lab experience in virus clearance studies and project management.
• Understanding of cGMP regulations and quality management is required.

Responsibilities

• Design and implement virus clearance studies to support regulatory filings.
• Function as a Study Director, overseeing planning and conducting studies.

Skills

Problem Solving

Analytical Skills

Communication Skills

Teamwork

Education

Degree in Biological Science

PhD in Biological Engineering

Tools

Chromatography Systems

Ultra Filtration Systems

Dead-End Filtration Systems

Job description

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.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

The Development Services group is responsible for the development and characterization manufacturing processes used for the production of novel therapeutic recombinant proteins for Lonza’s global client base.

Based primarily in a new site in Singapore Science Park, the viral clearance team works closely with our customers, and with different functions including MSAT, Manufacturing, Regulatory, Proposal/Program Management, Process Development, Supply Chain, Quality Assurance and external testing facility.

As a Lead Scientist you will act as a Study Director to independently design and implement specific virus clearance studies that demonstrate the efficiency of purification processes for the reduction of viruses to support customers’ regulatory filings (IND & BLA).

Key responsibilities:

1. Function as a Study Director, who has the overall responsibility of planning and conducting, as well as the interpretation, analysis, documentation and reporting of results.
2. Design viral clearance studies in accordance with guidelines (e.g. EMEA and ICHQ5A) and perform hands-on laboratory work (e.g. small-scale control run, virus models spiked run, virus inactivation step evaluation, virus reduction filtration) following protocols and working to GMP standards.
3. Follow work procedures to set up and operate chromatography, ultra filtration and dead-end filtration systems to GMP standards.
4. Review and interpret raw data to produce good quality process knowledge and data sets suitable for inspection by regulatory agencies.
5. Authoring of protocols and reports and interaction with regulatory agencies required.
6. Supervision of project teams and leading troubleshooting activities required.
7. Develop and maintain relationships with external customers and teams at contract testing laboratories.
8. Deliver high quality communication to ensure an outstanding customer experience (written reports, telecons, face to face meetings).
9. Work as part of a site and global project team, co-ordinate multiple projects and ensure timely delivery of project work stages.

Key requirements:

1. Degree/PhD in Biological Science/Engineering as appropriate for area of expertise.
2. 4-7 years’ experience or 2-5 years and a PhD with experience gained in a lab either in industry or academia, or via an industry work training programmed.
3. Practical laboratory experience in virus clearance studies, study directing, and project management is required.
4. Developing a detailed understanding of the scientific rationale behind one or more technical areas involved in the development of biopharmaceuticals.
5. The final role offered will be commensurate with the candidate’s experience.
6. Understanding of cGMP regulations and quality management is required.
7. Excellent problem solving and analytical skills.
8. Excellent communication skills (verbal and written).
9. Excellent teamwork skills.

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 significant difference.