Principal Scientist, R&D

Job Description

The Principal Scientist, R&D will be responsible for all aspects of analytical development including characterization for drug substances (DS) and drug products (DP). This position is responsible for performing project leadership for analytical method development for drug substance/product development for release and stability, manufacturing support, and regulatory submissions assistance to clients and subcontractor vendor management.

Key Responsibilities

  • Within the R&D group, the Principal Scientist, will be primarily responsible for developing analytical methods for a variety of therapeutic protein candidates
  • Scope of work will include, but is not limited to, analytical method development, implementation & transfer, biochemical and biophysical characterization of proteins, analytical development technologies, upstream and downstream process development support, data analysis
  • Project execution and reporting of client projects according to budget and timelines developed by the project team
  • Phase appropriate development, validation, and transfer of robust analytical methods for starting materials, in-process control, DS and DP testing
  • Oversee the execution routine R&D testing
  • Demonstrate attention to detail in the planning, execution, and documentation of experimental work
  • Write development reports, validation protocols, and ensure their timely delivery and communicate with the GMP team
  • Compile and analyze experimental data to generate method knowledge and develop strategy
  • Serve as a technical leader for equipment and technologies for analytical development
  • Participate as SME in project team meetings with clients
  • Represent & promote end-to-end and biologics development activities (presentations and events)
  • Lead the overall projects (supervise analytical development and implementation of new methods and services)
  • Support follow-up and troubleshooting on analytical methods from the GMP team
  • Oversee the efforts of scientists through a matrix relationship within the organization
  • Ensure a continuous improvement environment within analytical development activities
  • Ensure compliance with analytical requirements for CMC regulatory submissions

Education and/or Experience

  • A PhD with 5+ of experience or master’s degree with extensive experience in Protein Chemistry, Drug Development, or equivalent experience is required
  • Biotherapeutic drug development life cycle and analytical method development experience

Skills and Qualifications

  • Interpersonal Skills – Must have strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner.
  • Communication Skills – Excellent oral and written communications with ability to present data to all levels of audiences
  • Productivity/Organizing/Planning – Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously
  • Strategic Thinking – Capable of strategic thinking and proposing innovative solutions to drug substance and drug product analytical method development problems
  • Collaboration & Teamwork – Must be capable of collaborating in a team environment. Should be able to influence through effective communication and be flexible and responsive to changes in priorities and planning.
  • Ability to critically analyze data using statistical tools and to compile technical reports
  • Excellent presentation and communication skills
  • Results-oriented with ability to work and deliver under pressure
  • Scientific problem-solving skills, including the ability to identify critical issues in experimental work and to suggest possible solutions
  • Strong analytical, communication, presentation, and writing skills
  • Ability to strategically plan, organize and manage multiple projects
  • Ability to exercise independent judgment with minimal supervision
  • Ability to work cross-functionally in a fast-paced team environment
  • Experience with regulatory submissions and communication with healthcare authorities an advantage

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