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Senior Scientist, Method Development

Aplica ya
Mapa de ubicación: Durham, North Carolina, United States Full time R1227357

Descripción del trabajo

JOB SUMMARY:

As a Senior Scientist, candidate will be responsible for developing bioanalytical immunoassay or cell-based assays supporting PK/PD concentration and immunogenicity assessment. By applying expertise in ligand binding assays such as ELISA and ECLA, bioassay and immunological techniques to quantitate biotherapeutics and biomarkers and to characterize immune responses to biologics, candidate will turn hope into help by accelerating our partners’ drug development programs. Contributions to this platform of testing will support multiple modalities across the spectrum of drug development in a custom-built state-of-the-art laboratory that includes bioanalytical, vaccines, genomics, anatomical pathology and flow cytometry laboratories.

RESPONSIBILITIES:

  • Responsible for planning the development process, writing of methods, and execution of method development experiments as needed.
  • May be responsible for validation of the method and support delivery of analytical testing, as needed.
  • Responsible for assay troubleshooting for process optimization.
  • May contribute to resolution of lab investigations.
  • Responsible for transfer of method to the validation process.
  • Collaborates cross-functionally to ensure identified to ensure methods will be sustainable and scalable in laboratory operations.
  • Demonstrates advanced domain knowledge to provide input on technical inquiries and provide leadership in troubleshooting projects, including application of root cause analysis and advanced problem-solving techniques.
  • Mentors and trains junior level staff.
  • Leads technical projects of low to moderately complexity and oversees the work of those assigned to the project to ensure deliverables are achieved.
  • Works proactively across functions to ensure effective delivery to the customer and deployment of the assay.
  • Contributes to scientific literature and conferences, internal reports, documentation, and communications.
  • Supports the maintenance and operational standards of lab equipment.
  • Participates in the evaluation and validation of new lab instrumentation.
  • May present findings to a wide variety of audiences internal and external to Q2 Solutions.
  • Maintains laboratory notebooks under applicable regulatory standards and good documentation practices.
  • Follows all appropriate lab and company procedures and policies.
  • Performs work in accordance with applicable regulatory requirements.
  • Contribute to Six Sigma initiatives.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE:

  • Bachelor’s Degree in relevant scientific discipline with 4 years of related experience in method or assay development or specific methodology area OR
  • Equivalent combination of education, training, and experience in GLP laboratory environment.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

  • Sound knowledge of assay/method development and scientific principles, theories, concepts, and state of the art instrumentation, typically obtained through advanced education.
  • Understands the phase of development relevant to the assigned method and interactions/implications of method development across cross functional areas.
  • Sound trouble shooting capabilities.
  • Basic knowledge of requirements under relevant regulatory standards for assigned work area.
  • Good computer skills including proficiency with Microsoft Excel, PowerPoint, and Word.
  • Strong organizational skills, and close attention to detail are essential.
  • Effective communication and presentation skills.
  • Ability to maintain a degree of independence to complete assigned tasks and projects.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
  • Ability to process and apply complex information from various topics.
  • Capable of handling multiple tasks simultaneously and independently.
  • Demonstrated “everyday leadership” skills.
  • Ability to maintain a minor degree of independence to complete assigned tasks and projects.
  • Ability to bring projects and deliverables to completion under timeline expectations.

PHYSICAL REQUIREMENTS:

  • Sit at a desk or table with some walking, standing, bending, stooping, or carrying of light objects.
  • Use hands and fingers to handle and manipulate objects and/or operate equipment.
  • Perform unaided lifting of objects.

Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. https://www.q2labsolutions.com/careers

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe

As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status

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