Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Key responsibilities:

The primary purpose of this position is to contribute to developing, validating, and implementing bioanalytical immunoassays for the measurement of biotherapeutics, biomarkers, and the detection of anti-drug antibodies (i.e., immunogenicity) in biological samples to support drug development and regulatory filing.

Develops, validates, and implements immunoassays for the analysis of clinical and non-clinical pharmacokinetic or toxicokinetic samples in a GLP-like or GLP environment with some level of guidanceAuthors validation and other analytical reports, BAS sections to the TK and clinical study reports. Contributes to the preparation of BAS sections to regulatory filings, BAS responses to regulatory filings, SOP’s, and other guidelinesProcesses bioanalytical study samples using validated methods.Reports study sample results to clients following the departmental policies and procedures.Troubleshoots and fixes ordinary assay problemsEnsures compliance with and maintains required training in company and departmental GLP, SOP, safety and other departmental guidelinesUse Watson, ELN for processing and documentation of dataEnsures that electronic notebooks and other documentations are up to date as per departmental guidelinesAchieves objectives in a manner consistent with the Core BehaviorsPrepares and makes scientific presentations at internal and external meetings

Education and Experience:

Bachelor's degree in lab sciences such as Biology, Biochemistry, Immunology, Molecular Biology or similarSr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’)OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)OR PhD

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

Possess a solid understanding of basic analytical concepts (concentration units, pH, calibration curves, QC's compliance, etc.) and basic analytical laboratory operational skills (pipettes, balances, computer skills), etc.At least 2 years of ELISA experience in a GLP or GMP regulated lab is required.Must be able to work in a methodical and organized fashion; understand and follow methods or research protocols and write in a concise and accurate manner to record all data in a research notebook.Robust theoretical understanding of ligand binding assay (LBA) immunoassays (i.e., ELISA, ECL, Gyros) and familiarity with method validation and sample analysis.Ensure notebook and documentation is maintained per departmental guidelines and regulatory expectationsHave experience with biological sample handling and assay execution in a 96-well format.Have an understanding of instrumentation and performance troubleshooting.Have working knowledge of GLPs, FDA Bioanalytical Guidance, and general laboratory practices.Possess communication and organizational skills in a cross-functional environment.Knowledge of instrumental and protocol troubleshooting.Ability to work in a collaborative work environment.Proven problem solving and troubleshooting abilities.May travel to go to specific meetings or trainings.

Working Environment:

Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary and/or standing for typical working hours.

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with

proficiency.

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!