Assistant Laboratory Manager

Summary

The Assistant Lab Manager is responsible for the leadership of the microbiological contract services laboratory in Charles River Singapore and ensure that lab operates in accordance to ISO17025 and cGMP requirements. Assistant Laboratory Manager will serve as analytical lead in variety of projects which includes but not limited to method validation, method transfer, customized testing activities. In addition, this individual is responsible for directing the day-to-day project activity though interaction with technical personnel while gathering, analyzing and interpreting scientific data. He/She must ensure accurate and precise results are being achieved and properly reported.

Roles and Responsibilities

- Provides strong, independent technical leadership to technical personnel.

- Lead, design and performs method development and validation of new test procedures for incoming projects.

- Functions as Technical Reviewer for A2LA accredited tests and non-accredited tests.

- Evaluates analytical results to form interpretations of data and renders scientific opinions for client-driven projects.

- Serves assubject matter expert in area of specialization, established standards forregulatory compliance.

- Serves as technical liaison with Customers with regards to technical services and performs Customer Site Visits where required.

- Prepares documents including methods, procedures, standard operating procedures, study protocols, summary reports.

- Assures that SOPs are in accordance to ISO 17025, cGMP and other regulatory requirements.

- Provides problem-solving skills for test procedures and investigations within laboratory unit.

- Responsible for notifying Quality Assurance and Senior Management of any compliance deficiencies or concerns in timely manner.

- Monitor all proficiency-based testing and ensure compliance.

- Participates in Internal Quality Audits, System Audits, Audits conducted by external agencies and Regulatory Authorities.

- Participate in quarterly management review.

- Drive process, quality and safety improvement initiatives within the department.

- Provide coaching and mentoring to technical personnel.

- Supports the Laboratory Manager in all relevant functions

Qualification Requirements

- Bachelor of Science or related degree, MSc. preferred but not essential.

- Minimum 6years relevant QC microbiological experience in regulated laboratory, minimum 2of which should be in a supervisory role.

- Experience in method validation, method transfer, qualifications activities in regulated laboratory.

- Good knowledge of ISO17025, cGMP and other regulatory guidelines.

- Good technical understanding and judgement.

- Good interpersonal and communication skills across cultures.

- Team player with ability to work in cross functional teams as well as independently depending on the requirement of task in hand.