Scientist 2, Analytical Development & Method Validation
Lonza
Tuas, Singapore,SG
11d ago

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success.

Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.

Our vision :

We strive to be the leading supplier using science and technology to improve the quality of life.

Our mission :

We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.

Do you want to help us as we shape the future of this great organization?

Job Description Summary

The successful applicant for this position will be joining the Analytical Development team within Clinical Development in Lonza Singapore, focusing on test method validation, development and life cycle management.

The Clinical Development 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 participate in 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 scales to a high standard in compliance with ICH guidelines, cGMP and business principles.

Duties and Responsibilities include :

  • Participate in study programmes undertaking the execution of associated laboratory work in 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, ELISAs, etc.
  • Maintenance of test method life cycles, analytical equipment, and related technologies and / or systems.
  • Author study protocols and reports, ensuring delivery of high quality and GMP compliant data.
  • 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.
  • Participate in customer (internal and external) communications (written reports, teleconferences and face to face meetings).
  • Working as part of site and global project teams, co-ordinate multiple projects and ensure timely delivery of project work stages.
  • Facilitate communication between other departments in Singapore (eg QC / QA) and across the global Lonza network.
  • Participate in atypical / OOS investigations within the laboratory.
  • 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)
  • General

  • To work to the highest scientific standards under the direction of the Line Manager.
  • To communicate project updates to internal and external customers.
  • 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.
  • Contribute to 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-organised 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.
  • Education Experience

  • Degree / PhD in a relevant Science field or Equivalent
  • Minimum 3 years work experience or a recent PhD
  • Practical laboratory experience in analytical testing for antibodies or proteins is required although training will be provided
  • Understanding of theory and application of protein production and purification
  • Good problem solving and analytical skills
  • Good communication skills (verbal and written)
  • Good team working skills
  • Good understanding and application of cGMP concepts.
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