Director, CMC Analytical Development
Position Summary: 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 analytical strategy and in particular contribute to analytical development strategy in support of discovery and 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 VP of Technical Operations.
A more complete description of the position, and experience required, is listed below:
Position Purpose: The purpose of this position is to ensure that:
- Analytical test methods to release and deliver (a) APIs, their starting materials and intermediates, (b) bulk drug product, and its intermediates, and (c) investigational medicinal product are phase-appropriately developed for use in nonclinical studies and for further processing in a timely manner
- Oversight of contract manufacturing organizations conducting analytical quality control testing, analytical method development studies, including stability studies. Provide direction to the CROs in terms of design of analytical test methods and qualification strategies, 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
- Analytical development strategy is phase-appropriate and positioned for accelerated development validation to support commercialization
- Expert knowledge in regulatory/cGMP requirements (for both the US and EU Directive) is applied for CMC analytical and effectively communicated to functional groups across all levels of the organization and competent authorities.
Job Description: This role will provide leadership and management in the planning and execution of analytical method development activities. The candidate must be accomplished (demonstrated by experience and successes) with the applications of CMC analytical expertise and as an expert in the field, will function as Principia’s analytical representative at contract research/manufacturing organizations. The candidate will lead Principia in the innovation and development of Principia’s analytical development strategy for technical operations. The candidate will be responsible for: leading phase-appropriate development and validation of analytical methods; 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 lead cross-functional projects, budget planning and lead the design and execution of analytical method development strategies.
Qualifications: Minimum of Bachelor’s degree (ideally in Chemistry or Biochemistry) in a technical field: PhD with 7+ years of industrial analytical development experience is preferred, Master’s degree with 9+ years of experience, or Bachelor’s degree with 12+ years of experience. The successful candidate is familiar with current statistical techniques used in method development and validation. Previous experience in API or drug product manufacturing of small molecule, early to late phase, solid oral dosage product focus analytical method development is required. Proven success in devising analytical 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 analytical techniques and regulatory documentation and submission, and demonstrated successes in qualifying or validating as appropriate for the stage of development. Strong knowledge and demonstrated practice broad array of analytical instrumentation and processes such as pH meters, HPLC, UV/Vis spectroscopy, USP dissolution testing apparatus, moisture analysis by Karl Fischer, and their analytical method validation. Experience with disintegration, DSC, TGA, hardness, and friability testing 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.