Senior Analyst

Charles River Laboratories; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading contract research organization in Singapore is seeking a Senior Analyst to ensure laboratory operations comply with ISO 17025 and cGMP requirements. The role involves leading method development, directing project activities, and serving as a subject-matter expert. Ideal candidates will have a degree in a related field and 2-6 years of laboratory experience. This full-time position offers a unique opportunity to impact the health and well-being of people worldwide.

Qualifications

• Minimum 2-6 years of relevant QC microbiological experience in ISO 17025 / GMP laboratory.
• Experience in method validation and development, method transfer.
• Good knowledge of ISO 17025, cGMP and other regulatory guidelines.

Responsibilities

• Provides strong independent technical leadership to personnel.
• Leads method development and validation of new test procedures.
• Evaluates analytical results and provides scientific opinions.

Skills

Good interpersonal and communication skills across cultures

Team player with ability to work independently

Good technical understanding and judgment

Experience in method validation and development

Team player with ability to work in cross‑functional teams

Education

Bachelor of Science or related field; MSc preferred

MSc. preferred

Tools

Splunk

Microsoft Access

SQL

Malware Analysis

Tableau

Job description

For nearly 75years Charles River employees have worked together to assist in the discovery development and safe manufacture of new drug therapies. Whether you join our family you will have a significant impact on the health and well‑being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area your skills will play an important role in the work we do and help you build a career you can be passionate about.

POSITION SUMMARY

This role is responsible for ensuring the laboratory operations are in accordance with ISO 17025 and cGMP requirements.

He / She will serve as analytical lead in a variety of projects, which includes but is not limited to method validation, method transfer, customized testing and additional directives. The individual is responsible for directing the day‑to‑day project activity through 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.

DUTIES & RESPONSIBILITIES

• Provides strong independent technical leadership to technical personnel
• Leads designs and performs method development (i.e. bioassay and mycoplasma) 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 as subject‑matter expert (SME) in area of specialization, established standards for regulatory 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 (SOP) and study protocol summary reports
• Assures that SOPs are in accordance with ISO 17025, cGMP and other regulatory requirements
• Provides problem‑solving skills for test procedures and investigations within the laboratory unit
• Responsible for notifying Quality Assurance and Senior Management of any compliance deficiencies or concerns in a timely manner
• Monitors all proficiency‑based testing and ensures compliance
• Participates in internal Quality Audits, system audits, audits conducted by external agencies and regulatory authorities
• Participates in quarterly management review
• Drives process quality and safety improvement initiatives within the department
• Job Description: Senior Analyst
• Provides coaching and mentoring to technical personnel
• Supports the Laboratory Manager in all relevant functions
• General requirements
• Maintains confidentiality of all client information according to internal SOPs and quality service
• Agreements and regulatory requirements
• Actively seeks improvement within area of responsibility and takes necessary action to implement such improvements
• Adheres to company policies and procedures including code of ethics and to health and safety requirements
• Performs all other related duties as assigned

QUALIFICATIONS

• Bachelor of Science or any related field; MSc. preferred but not essential
• Minimum 2‑6 years of relevant QC microbiological experience working in an ISO 17025 / GMP laboratory environment
• Experience in method validation and development, method transfer, and qualification activities in regulated laboratory
• Good knowledge of ISO 17025, cGMP and other regulatory guidelines
• Good understanding/working knowledge of Project Management and Measurement Uncertainty (MU)
• Good technical understanding and judgment
• Good interpersonal and communication skills across cultures
• Team player with ability to work in cross‑functional teams as well as independently depending on requirement of task on hand

About Microbial Solutions

Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services that is unlike any other and has been purposefully designed to meet the complex and ever‑changing needs of the industry. We help clients to ensure product safety and quality with easy‑to‑use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.

About Charles River

Charles River is an early‑stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services both Good Laboratory Practice (GLP) and non‑GLP to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 20,000 employees within 110 facilities in over 20 countries around the globe we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our clients’ unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies, hospitals and academic institutions around the world.

At Charles River we are passionate about our role in improving the quality of peoples’ lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do and we approach each day with the knowledge that our work helps to improve the health and well‑being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.

At Charles River Laboratories we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.

Required Experience

Senior IC

Key Skills

Splunk, IDS, Microsoft Access, SQL, Cybersecurity, Intelligence Experience, Malware Analysis, Tableau, Analysis Skills, SAS, Data Analysis Skills, Analytics

Employment Type

Full Time

Experience

years

Vacancy

1