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Lawrenceville, New Jersey, USA, United States of America
Onsite
Work Schedule
First Shift (Days)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob 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.
Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.
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.
Summary:
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.
Essential Functions:
• 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 guidance
• Ensure assay performance meets regulatory expectations for specificity, sensitivity, precision, accuracy, and robustness.
• Independently troubleshoot and optimize ligand binding PK and ADA assays to ensure robustness and reproducibility.
• Maintain lab inventories and order lab supplies to ensure continuity of bioanalytical activities.
• Utilize Watson LIMS and Electronic Lab Notebooks (ELN) for data processing, documentation, and reporting.
• Ensures that electronic notebooks and other documentations are up to date as per departmental guidelines
• Prepare or contributes to study reports following the departmental policies and procedures.
• Ensures compliance with and maintains required training in BMS and departmental GLP, SOP, safety and other departmental guidelines
• Achieves objectives in a manner consistent with the Core BMS Behaviors
• Prepares and makes scientific presentations at internal and external meetings
Knowledge, Skills, and Abilities:
• Develops, validates and implements immunoassays for the analysis of clinical and non-clinical pharmacokinetic or toxicokinetic samples in a GLP environment with some level of guidance
• Contributes to 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 guidelines
• Processes bioanalytical study samples using validated methods.
• Reports study sample results to clients following the departmental policies and procedures.
• Troubleshoots and fixes ordinary assay problems
• Ensures compliance with and maintains required training in BMS and departmental GLP, SOP, safety and other departmental guidelines
• Ensures that electronic notebooks and other documentations are up to date as per departmental guidelines
• Achieves objectives in a manner consistent with the Core BMS Behaviors
• Prepares and makes scientific presentations at internal and external meetings
Education/Experience/ Licenses/Certifications:
• Bachelor's degree in relevant life sciences program field
• AND 4-6 years of relevant experience
Preferred: 4+ years in a CRO or GLP regulated laboratory environment
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.
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.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Compensation and Benefits
The salary range estimated for this position based in New Jersey is $80,000.00–$90,000.00.This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards