Scientist 3, Method Development and Validation

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 successful applicant for this position will be joining the Analytical Development team within Development Services in Lonza Singapore, focusing on test method validation, development and life cycle management. The Development Services group is responsible for the development and characterization of manufacturing processes used for the production of novel therapeutic recombinant proteins for Lonza’s global client base. The purpose of this role is to lead and execute studies on the development and validation of purity, impurity, identity or charged isoform analytical methods and to provide technical expertise to support troubleshooting activities at both laboratory and manufacturing scale to a high standard in compliance with ICH guidelines, GMP and business principles.

**The position will be based on Science Park II.**

**Key Responsibilities**
- Author, review and perform technical review of study protocols and reports, ensuring delivery of high quality and GMP compliant data.
- Lead and direct study programmes at a senior level including the execution of associated laboratory work
- Projects require the delivery of analytical method validation or development work packages for antibodies and other therapeutic recombinant proteins.
- Test methods include, but are not limited to, techniques using capillary electrophoresis, HPLC, spectrophotometry, iciEF, qPCR, ELISAs, etc.
- Maintenance of test method life cycles, analytical equipment, and related technologies and/or systems.
- Contribute to customer projects by generating and interpreting scientific data from experimental work.
- Technical review of data generated by others highlighting any unusual or atypical results and leading appropriate investigations.
- Deliver high quality communication to ensure an outstanding customer experience (written reports, teleconferences and face to face meetings).
- Coach, train and mentor junior members of the team to assist in their development, providing a transfer of knowledge and hands-on technical training.
- In capacity as a method SME and/or platform owner, represent Lonza in discussions with the customer about specific study results in support of project team as well as supporting customer and regulatory audits where required.
- Working as part of a site and global project team, co-ordinate multiple projects and ensure timely delivery of project work stages. Supervision of small project teams will also be required.
- Lead atypical/OOS investigations within the laboratory.
- Facilitate communication between other departments in Singapore (eg QC/QA) and across the global Lonza network.
- Manage assay transfers across laboratories and sites when necessary.
- Owner of quality records (Deviations, CAPAs, change controls, tasks, effectiveness checks).
- Experience working within a formal Quality Management System (such as cGMP)
- To work to the highest scientific standards under the direction of the Line Manager.
- To contribute to the efficient running of the department including instigating and delivering operational efficiency projects.
- Contribute to departmental safety and training programmes as required.
- Dependent on scale of project, supervision of project teams may be required.
- Lead improvements in scientific practice and identify error traps within the laboratory and within processes to improve standards.
- The role may require occasional weekend work.
- Well organized with good problem-solving skills, a high level of attention to detail and have a passion for delivering high quality data on time.
- Execution of multiple projects simultaneously, ensuring work is planned and scheduled appropriately and delivered to agreed timelines and quality standards.

**Key requirements**:

- Degree/PhD in a relevant Science field or Equivalent
- Minimum 5 years' work experience or PhD with 2 years’ postdoctoral experience
- Practical laboratory experience in analytical testing for antibodies or proteins is required although training will be provided

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