- 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 characterization studies according to the principles of Quality by Design (QbD). This include a one-variable-at-time (OVAT) and DOE studies to identify the proven acceptable ranges (PARs) of the critical process parameters (CPPs) in efforts to link to the API critical quality attributes (CQAs).
- 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
- Perform specification justification studies to establish limits of APIs, intermediates and regulatory starting materials
- 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 and prior successes with at least one late stage chemical development program 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 which includes reviewing and approving quality control documents and test results. The candidate will work with cross-functional teams and will have the opportunity to lead the design and execution of chemical development activities. 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 three years of industrial chemical development experience is preferred, Master’s degree with at least five years of experience, or Bachelor’s degree with at least eight years of experience. The successful candidate is familiar with current manufacturing processes and equipment used in chemical development and validation. Previous experience in API manufacturing of small molecule, early to late phase development is required. Strong and independent problem-solving, ability to troubleshoot especially relevant to process chemistry issues is required. Experienced in devising chemical development strategy in compliance with regulatory/cGMP requirements is a desired. Prior experience with IND/IMPD and NDA/MAA submissions area are also desired.
Experience and Skills: The candidate will a strong knowledge 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. Experience with drug substance solid forms and characterization of physical and chemical properties are desired. 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.
Principia Biopharma, Inc. is an equal opportunity employer.