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 Principal Scientist 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). The Principal Scientist role is a senior scientific and technical role, providing broad scientific, technical, and regulatory knowledge and lead delivery of assigned complex bioanalytical strategy and sponsored projects. The individual is a subject matter expert with in-depth expertise and experience in the field of bioanalytical sciences related to drug development. The role provides the leadership in developing scientific and technical strategy, development of new bioanalytical services, and the execution and implementation of new bioanalytical capabilities in collaboration with the key stakeholders and senior management to support business growth. The role is either an individual senior staff member or a team leader with significant independence and accountability to the scientific conduct and business impact of applicable project portfolio under its responsibility.
- Lead a scientific project team, have scientific oversight, and advance growth of specialized areas in bioanalytical sciences in alignment with Intertek Pharmaceutical Services, driving vision, market insight, strategy, plan, and execution within the scope of the project and program responsibility.
- Independently or collaboratively conduct relevant scientific research to gain insight of the industry needs, new technologies and regulatory guidance on bioanalytical services related to the field of expertise, in alignment with the strategy of Intertek Pharmaceutical Services, San Diego.
- Identify scientific & technical areas of growth potential to further the strategy of integrated bioanalytical services. Formulate strategy and vision of growth of new services within areas of expertise.
- Present, as a subject matter expert (SME), business and technical plans to senior management for buy-in and support for new capability development or improvement of existing technical operations.
- Provide scientific/technical direction, coaching, and guidance to junior scientific staff for issue resolutions for clients or internal development projects, providing interpretation of clinical protocol, method development, validation, and study-related issue resolution.
- Lead a small team of project scientific/technical staff to execute internal or sponsored projects, providing the scientific oversight and accountability for project quality and delivery timelines.
- Function independently as contact for the planning and execution of sponsor activities related to assigned studies, including scheduling and conduct of experiments.
- Provide scientific consulting on study design, protocol review, and bioanalytical project design as required by clients.
- Function as a point of scientific and/or technical consultation to clients in design and execution of bioanalytical projects. Provide project scientific support for issue resolution.
- 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.
- Publish business appropriate scientific and technical articles related to and promoting the bioanalytical services offered by Intertek Pharmaceutical Services, San Diego.
- 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:
- Ph.D. in related life sciences with a minimum of 8 years of experience working directly in the field of expertise, with a significant period working in a regulated environment (GLP/GMP/CLIA)
- Master's degree in related life science with a minimum of 10 years of direct industry and field of experience, including at least 6 years of experience working in a regulated environment (GLP/GMP/CLIA)
- Bachelor's degree in related life sciences with a minimum of 15 years industry experience, including at least 5 years of experience working in a regulated environment (GLP/GMP/CLIA)
- Demonstrated track record and success by scientific publications or project accomplishment in a field(s) of life sciences, such as pharmacology, toxicology, immunology, or key clinical therapeutic areas.
- Possess in-depth expertise and direct working knowledge of bioanalytical sciences such as immunochemistry, mass spectrometry, in vitro cell-based assays, clinical chemistry, protein chemistry, and more in analytical biosciences especially related to drug discovery and development.
- Proven working knowledge in one or more of the following bioanalytical fields as required by the specific working group:
- Applied immunoassay techniques for development of immunoassay methods in support of protein therapeutic pharmacokinetic and multi-tiered immunogenicity assays on various technology platforms such as ELISA, Meso-Scale Discovery, Luminex, and other platforms.
- Application of mass spectrometry for small molecules and biotherapeutic drug development, particularly in pharmacokinetics, toxicokinetics, and analytical characterization.
- Fit-for-Purpose biomarker discovery and development in support for drug development.
- Cell biology and immunology techniques as applied to drug development.
- Previous experience applying immunoassay techniques in support of GMP compliant CMC
- Proven track record of successful staff management as a team or project leader. Success in development of junior staff and performance is necessary for team leader responsibility as this position may be required to lead a small team.
- Effective written and verbal communication skills.
- Ability to handle 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.
- 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.
- This position requires working in a dynamic laboratory environment and coordinating your activities with the activities of other laboratory personnel. In situations of unusually heavy workload or fast turnaround requirements, overtime on weekdays and/or weekends may be assigned.
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.