Scientist, Chemical Development

Location
South San Francisco, CA, United States
Posted
Nov 12, 2020
Ref
730576523
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Principia Biopharma is a biopharmaceutical company engaged in discovery and development of novel small molecule therapeutics in the areas of oncology and autoimmune diseases. As such, Principia Biopharma is comprised of a team of exceptionally talented scientists and business leaders. Our employees experience transparent communication, and the sharing of ideas in an environment of mutual respect. We are seeking confident individuals who thrive in a culture of diversity, empowerment and accountability. The individual we seek will share these values and is a driven, strategic, and collaborative individual wiling to contribute to overall CMC development strategy and in particular contribute to chemical development strategy in support of Principia development programs. The ideal candidate will contribute in a culture of high performance, empowerment, learning, diversity and has a desire to be part of the department's leadership and the willingness to grow in their responsibilities.
A more complete description of the position, and experience required, is listed below:

Position Purpose: The purpose of this position is to ensure that:
  • Phase appropriate process development and characterization of chemical manufacturing process is implemented to produce and deliver APIs and their starting materials and intermediates, for use in manufacturing of clinical trial materials in a timely manner
  • Oversight of contract manufacturing organizations and serve as the person in plant during manufacture and help to troubleshoot should issues arise.
  • Perform process development and process optimization of clinical candidates
  • Review of quality control testing and certification that batches meet specifications and in compliance with GMP; and document and institutionalize all development activities as source materials for regulatory filings
  • Effectively communicate to cross functional groups (chemical development, analytical, Quality, program management and regulatory).


Job Description: This is an individual contributor role involved in the execution of chemical development activities. The candidate must have shown a history of accomplishments as demonstrated by prior experiences through the ability to identify and solve problems in a timely manner. The candidate will be able to support both early stage and late stage development programs. The candidate will work with cross-functional teams which includes reviewing and approving quality control documents and test results and will have the opportunity to lead the design and execution of chemical development activities. Working in the lab is expected to aid process development as well as troubleshooting efforts. When needed, the candidate will be expected to travel to contract research/manufacturing organizations and will function as Principia's chemical development representative.
Qualifications: Minimum of Bachelor's degree (ideally in Chemistry or Chemical Engineering) in a technical field: PhD with at least one year of industrial experience is preferred, Master's degree with at least three years of experience, or Bachelor's degree with at least six years of experience. Familiarization with current manufacturing processes and equipment used in chemical development is a plus. Strong and independent problem-solving, ability to troubleshoot especially relevant to process chemistry issues is required.
Experience and Skills: The candidate must have a strong understanding of process chemistry and demonstrated practice of broad array of chemical processing equipment, including familiarity with supporting analytical instrumentation such as HPLC, UV/Vis spectroscopy, mass spectrometry, moisture analysis by Karl Fischer, etc. and their application. Ability to thrive in a small group setting with limited administrative support, developing and maintaining collaborative internal and external relationships. Good organizational, communication and presentation skills, effective project and time management skills, and be able to work well under pressure. Motivated, self-directed, able to work autonomously and have a proven ability to work in a team environment.