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Scientist - Bioanalytical
2 weeks ago
For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When 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 perform. In return, we’ll help you build a career that you can feel passionate about.
**How will you have an impact?**:
- We are passionate about improving the quality of people’s lives. When you join our global family, you will help make a real difference in the world every day.
**Why Charles River**:
We offer an excellent integration program for our new employees as well as opportunities for internal growth and career development. Our other perks include:
**As of Day 1**:
- Competitive benefits we pay 90% of premiums (health and dental coverage).
- Access to a savings and retirement program including an employer contribution.
- Vacation & Personal Day Policy.
- Free telemedicine app for you and your family.
**Transportation**:
- Free parking
**What will you work on?**:
Act as a Study Director/ Principal Investigator responsible for the conduct of bioanalytical non-GLP studies and standard GLP studies using LC-MS/MS, HPLC-UV or any other analytical detection method, in compliance with the Good Laboratory Practice (GLP) Regulations of the Organisation for Economic Co-operation and Development Principles and the US Food and Drug Administration (21 CFR Part 58 and subsequent amendments).
- Act as a Study Director/Principal Investigator or Individual Scientist for non-GLP studies, as well as standard GLP Bioanalytical studies with support;
- Prepare and review study-related documentation (e.g. draft study plans, amendments, technical procedures, etc.), in collaboration with the Study Director (as necessary);
- Review toxicology study plans and amendments (sections pertaining to Bioanalytical), in collaboration with the Study Director/Principal Investigator and/or Individual Scientist;
- Maintain compliance with general scientific/regulatory standards in the Bioanalytical laboratory;
- Write and review technical reports and procedures;
- Interact with sponsors, suppliers, quality assurance auditors, regulatory auditors and Study Directors, as required;
- Assist with the development of techniques/assays to perform LC-MS/MS measurements of analytes in various matrices;
- Review analytical data generated by the services and ensure adequacy of record-keeping;
- Assist in effectively scheduling the activities for validations and analysis of biological samples in a multi-disciplinary laboratory using a variety of extraction techniques, manual testing, automated equipment and analytical instruments;
- Ensure that study personnel are fully aware of their required duties within the studies, including experiment conduct, data collection and integrity;
- Comply at all times with all departmental and company Standard Operating Procedures (SOPs);
- Identify events and take appropriate actions;
- Interpret regulatory guidance documents;
- Monitor and advise on validity of test results;
- Ascertain availability of test item, reagents, matrix, vehicle, etc. prior to commencement of studies and throughout their duration;
- Assist laboratory staff in the execution of method development/transfer, validation and sample analysis;
- Oversight of biological samples for analysis (receiving to disposal);
- Ensure all documentation associated with duties is maintained and up-to-date;
- Assist in training and oversee activities of junior Analysts as required;
- Assist in maintaining the calibration of laboratory equipment and instruments according to departmental and manufacturers’ schedules and procedures;
- Participate in the installation/certification and qualification of the equipment and analytical instruments.
- Assist in maximizing the utilization of all resources;
- Remain informed on technology developments and standards by self-education and/or external trainings, as required;
- Substitute and/or assist department colleagues;
- Perform any other reasonable tasks that may be required.
**Who are we looking for?**:
- Bachelor's degree in Chemistry, Biochemistry or related field or equivalent;
- Minimum of 3 years of relevant bioanalytical laboratory experience, including a minimum of 1 year in a scientific position relevant to Bioanalytical, ideally GLP compliant;
- Significant experience using LC-MS/MS with chromatographic data system;
- Experience with instrument and software validation (21CFR Part 11);
- Efficient time management;
- Reading and writing of English. Bilingualism is required;
- Good organizational, interpersonal and communication skills;
- Strong troubleshooting and analytical skills;
- Detail oriented and meticulous;
- Ability to work independently under time constraints and adapt to change;
- Flexibility to
