Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices and over 43,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers' operations and supply chains. Intertek Total Quality Assurance expertise, delivered consistently with precision, pace and passion, enabling our customers to power ahead safely.
This team serves the chemical and pharmaceutical industries with a diverse range of services, from chemical testing and consultancy to inspection, contract laboratory services, regulatory guidance and supply chain assurance
The Senior Scientist in the conduct of assigned clinical & nonclinical research studies at the Method Development (MD) stage of the Immunoassay life cycle. The MD Senior Scientist will directly report and communicate with the Scientific Director. The Senior Scientist will be responsible for driving daily MD activities for Preclinical programs or MD activities for Clinical programs at the bench level and updating Sponsors/Clients and internal Intertek stake holders regarding progress made on a weekly/bi-weekly basis. This position is responsible for performing all assigned and routine document related tasks in accordance with Intertek SOPs and relevant regulatory requirements to include Good Laboratory Practice (GLP).
- Function independently as a MD Senior Scientist in the direction and execution of assigned studies in compliance with GLP/GCP regulations as they apply to the conduct of nonclinical & clinical research. The Senior Scientist may also be required to execute bench duties based on resource availabilities.
- Participate, when required, in the proposal management and quote development process along with the Scientific Director and Business Development team serving as a key scientific contact for new and existing business partners.
- Participate in Sponsor/Client update meetings along with various Intertek internal stake-holders.
- Design and analyze experiments in accordance to SOPs and other industry guidance documents and assure appropriateness of immunoassay methods to stage of Sponsor drug development process.
- Review, interpret, integrate, and present data on assigned studies.
- Function independently as contact for the planning and execution of Sponsor interaction related to assigned studies, including scheduling and conduct of experiments.
- Provide oversight of the laboratory and mentor technical staff in areas such as protocol interpretation, method development and refinement, study-related problem resolution, and method validation. Provide scientific expertise in study conduct, design, and interpretation.
- Attend scientific meetings, conferences, and training courses to enhance job and professional skills. Present abstracts/posters at national meetings, when appropriate, to maintain a scientific presence and visibility in areas of individual expertise.
- Monitor performance of direct reports. Provide regular coaching and counseling for career development.
- Perform all other related duties as assigned.
- Education and experience must meet one of these 3 combinations:
- PhD with minimum 1-2 years of experience working in a regulated industry environment (GLP/GMP/CLIA).
- Master's degree in Science with minimum of 6-7 years industry experience, including at least 4years of experience working in a regulated environment (GLP/GMP/CLIA) supporting large molecule drug development.
- Bachelor's degree in Science with minimum of 7-8 years industry experience, including at least 7 years of experience working in a regulated environment (GLP/GMP/CLIA) supporting large molecule drug development.
- Proven knowledge of applied Immunoassay techniques through previously developed and validated immunoassay methods in support of protein therapeutic Pharmacokinetic and Multi-tiered Immunogenicity Assays on various technology platforms such as ELISA, Meso-Scale Discovery and Luminex.
- Previous experience applying immunoassay techniques in support of GMP compliant CMC Potency Assays and Fit-for-Purpose drug development Biomarker programs preferred.
- Effective written and verbal communication skills (Industry related, e.g., posters, presentations, publications).
- Leadership role in client meetings and communications.
- Ability to manage multiple projects, prioritize work and meet deadlines.
- Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, etc. and with standard laboratory calculations.
- Use of SoftMax and Watson LIMS preferred.
- Working in a biohazard laboratory or other laboratories known to contain radioactive or other potentially harmful chemicals.
- Continuous sitting, upward and downward flexion of neck; fine finger dexterity and light to moderate finger pressure to operate keyboard, equipment controls, pipetting and other office equipment.
- Frequent side-to-side turning of neck, walking, standing, bending and stooping, pushing/pulling, twisting at waist, moderate wrist torque to twist equipment knobs and dials; lifting objects weighing up to 20 lbs. from below waist to above shoulders and transporting.
- Occasional squatting, kneeling, reaching above and at shoulder height, moderate grasping to manipulate reference books and manuals; lifting objects weighing 20-35 lbs. from below waist to above shoulders and transporting distances up to 50 feet.
A career with Intertek means joining a global network of professionals dedicated to bringing quality and safety to life. Our vision is to become the world's most trusted partner for Quality Assurance and we offer our employees the chance to make an impact with attractive growth opportunities in this industry on a global scale.
We offer a salary and benefit package competitively placed within the local market, including medical, dental, vision, life, disability, 401(k) with company match, tuition reimbursement and more.