Scientist III, Bioanalysis 2024 - LanceSoft Inc
Fulton, MO
About the Job
- The Scientist III (Bioanalysis) is responsible for initiating, developing, and performing assays leading to the quantitative determination of drug and metabolites in biological matrices (e.g., plasma, tissue, environmental etc.) using LCMS and/or HPLC instruments in accordance with local and global regulatory requirements.
- This may include but not limited to residue analysis for pharmacokinetic, metabolism, human food safety, efficacy, and target animal safety studies to support the development of new products and the maintenance of existing products. Accountable for delivering reliable and reproducible data and meet aggressive timelines.
- Independently operates and troubleshoots lab equipment s (e.g., LCMS/HPLC) and is independently responsible for maintaining in a validated state.
- Assembles or sets up equipment, obtains appropriate service for repair when needed. Executes protocols, modifies, and follows existing analytical methods with limited supervision.
- Performing method demonstration for regulatory agency and participate in method trials.
- Complies with all applicable regulations (GLP compliance, Animal Welfare, Regulatory requirements etc.).
- Ensures that work performed in area of responsibility is conducted in a safe and compliant manner.
- Maintains proper records in accordance with SOPs and policies. Ability to strictly follow SOPs.
- Records, evaluates, interprets, and reviews technical data with limited supervision in compliance with regulatory requirements and prepares data for inclusion in project reports.
- Prepares reports and memos with limited guidance. Drafts detailed method descriptions to be followed by other chemists or other laboratories.
- Writes periodic progress reports. May prepare and review drafts of SOPs and regulatory documents or reports.
- Conduct 2nd chemist check of the data and reports.
- Independently demonstrates technical ability to assist in the design and execution of non-routine experiments.
- Proposes new experiments/technologies based on science as well as overall understanding of drug discovery/development process.
- Independently applies basic scientific principles, performs literature searches, extracts relevant information, attends scientific meetings, and keeps abreast of literature in own field.
- Demonstrates expertise in field and contributes to training technicians and junior level scientists.
- Contributes to project and task force teams and functions as Investigator or Principal Investigator for studies with limited supervision. Acts as a professional & collaborative team member demonstrating, accountability and alignment within the global bioanalytical team and with all stakeholders.
- Ensures that work performed in area of responsibility is conducted in a safe and compliant manner.
- Strictly maintains proper records in accordance with SOPs and policies. Ensures a safe working environment in the laboratory and office according to HSE policies.
- Interacts well with other personnel within and outside the company to facilitate completion of assignments. Maintains, develops, and improves technical skills and knowledge through appropriate training. Has the ability to work effectively in teams and is able to shift priorities and projects as company needs changes.
Skills:
- The successful candidate will have experience with more than one of the following skills.
- Prior pharmaceutical industry R&D experience.
- Hands-on experience with analytical method development, validation, and sample analysis with demonstrated ability to accurately collect, analyze, and report the results.
- Ability to operate laboratory equipment without supervision.
- Ability to work as bench chemist, knowledge of chemistry and related fields contributing to an understanding of the basic principles of chromatography, mass spectroscopy and sample extraction techniques.
- Capable of performing quantitative analysis using HPLC, LC/MS-MS instruments.
- Experience in planning, conducting, and reporting bioanalytical studies.
- Able to effectively work in an international and cross-functional matrix environment.
- Knowledge of GLP and a good understanding of FDA and EMEA regulatory requirements for drug product registration.
- Sense of urgency to deliver outstanding data within aggressive timelines.
- Collaborates and interfaces with local site operations, quality assurance, EHS and global project teams.
- Skilled in the use of computers for calculations, word processing, instrument control applications and other tasks.
- Good communication skills, both verbal and written. Fluent in English (read, write, and speak).
- Accepts accountability and ownership. Exhibits integrity and trust.
Education:
- Master s degree from an accredited institution with one-plus (1+) years of experience in a related scientific discipline (Chemistry, Analytical chemistry, Biochemistry preferred) OR Bachelor s degree from an accredited institution with seven-plus (7+) years of experience in related scientific discipline.
- Candidates with significant experience in the related field or with PhD degree with relevant experience will be considered for Scientist IV position.
Required
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- ENVIRONMENTAL LAB
Source : LanceSoft Inc