Senior Manager/Associate Director, Chemical Development
We’re 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 leader wiling to contribute to overall CMC development strategy and in particular contribute to chemical development strategy in support of late phase developmental programs at Principia. 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. This position reports into the Senior Director of Chemical Development.
A more complete description of the position, and experience required, is listed below:
- 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 conducting process development studies according to Quality by Design (QbD), specification justification studies to establish limits, process characterization studies such as one-variable-at-time (OVAT) and DOE studies to identified proven acceptable ranges (PARs) of critical process parameters (CPPs), including identification of edge-of-failure (EoF), characterization of APIs to identify critical quality attributes (CQAs). Provide direction to the CROs in terms of design of chemical development strategies during clinical development and design of registration strategies for commercial supply chain(s), review and approval of release testing data, as well as stability data. 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
- Design chemical development strategy that is phase-appropriate and well positioned for accelerated development, and design and execution of validation master plan to support commercialization
- Expert knowledge in regulatory/cGMP requirements (for both the US and EU Directive) is applied for CMC development strategy and chemical development, and effectively communicate to functional groups across all levels of the organization and competent authorities.
This role will provide leadership and management in the planning and execution of chemical development activities. The candidate must be accomplished (demonstrated by experience and successes, with at least one successful validation of chemical development plan for commercialization) with the applications of chemical development expertise and as an expert in the field, and will function as Principia’s chemical development representative at contract research/manufacturing organizations. The candidate will lead Principia in the innovation and development of Principia’s chemical development strategy for technical operations. The candidate will be responsible for: leading phase-appropriate development and validation of manufacturing process; reviewing and approving quality control test results; and applying expert knowledge in regulatory/cGMP requirements in responses to requests for information from competent authorities. The candidate will work with cross-functional projects and lead the design and execution of chemical development strategies. A willingness to work in the lab to solve process chemistry issue is highly desired.
Minimum of Bachelor’s degree (ideally in Chemistry or Chemical Engineering) in a technical field: PhD with 8+ years of industrial chemical development experience is preferred, Master’s degree with 10+ years of experience, or Bachelor’s degree with 15+ 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 a must. Experienced in devising chemical development strategy in compliance with regulatory/cGMP requirements (for US and EU Directive, US and ICH regulatory guidance). Prior experience with IND/IMPD and NDA/MAA submissions are required.
Experience and Skills:
The candidate will have proven leadership, and in depth knowledge of a broad spectrum of chemical development and regulatory documentation and submission, and demonstrated successes in qualifying or validating as appropriate for the stage of development. Strong knowledge 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 also 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.