Pearl Therapeutics, a wholly-owned subsidiary of AstraZeneca, is a growing, dynamic company focused on developing inhalation combination therapies for the treatment of highly prevalent chronic respiratory diseases, including chronic obstructive pulmonary disease (COPD) and asthma. Pearl is seeking to hire individuals that bring energy and passion to deliver the medicines that provide patients and healthcare provider’s therapies to achieve better clinical outcomes.
Purpose: This role reports in to the Director of Product Development and leads pressurized metered dose inhaler (MDIs) development and in-market support activities. The ideal candidate will have development experience with drug-device combination products, including inhalation products, and a working knowledge of medical device design controls. Moreover, knowledge and experience in how suspension MDI formulations interact with the valve can, and actuator is required. In addition, the candidate should have strong problem solving and communication skills with the drive and leadership qualities needed to deliver on project goals. Experience authoring US and international regulatory documents is desired.
Duties and Responsibilities:
• Effectively lead, guide, and mentor a team of product development scientists on both the technical and non-technical requirements of inhaled product development.
• Drive or participate on technical development teams with focus on product development, formulation, characterization, and risk mitigation.
• Provide strategic direction for and lead implementation of design control activities for inhalation combination product development in order to maintain compliance with 21 CFR 820.30.
• Accountable for product development-related regulatory sections filed across global markets (e.g., IND, NDA, IMPD, MAA, JNDA, etc.).
• Foster collaboration internally with Analytical Sciences, MDI Manufacturing, Quality Assurance, and Regulatory Affairs to effectively deliver on product development goals.
• Interpret large data sets and communicate data impact or value to senior R&D leadership.
• Ensure GMP compliance where necessary.
• Depending on position, PhD – 10+ years, MS – 12+ years, BS – 15+ years of relevant industry experience. Degree in Mechanical or Biomedical Engineering, Pharmaceutical Sciences, Materials Science, Chemistry, or a similar applicable discipline.
• Proven record of successful product development leadership, project planning, and problem solving in the area of inhalation products and/or medical devices, including working with a sense of urgency to meet project goals.
• Ability to drive, lead and influence within the product development functional areas as well as more broadly across AstraZeneca operations in order to meet project goals.
• Ability to adapt to and manage change both internal to the organization and response to the external environment (e.g. regulations, market trends, etc)
• Working knowledge of FDA and CHMP guidances for inhalation products, including human factors engineering.
• Working knowledge of and experience with all aspects of medical device design controls under 21 CFR 820.30 and cGMPs for pharmaceutical products.
• Experiences as medical device responsible person desired.
• Strong oral and written communication skills.
• Experience authoring NDA/MAA both pharmaceutical development and medical device regulatory sections.
• Experience as a subject matter expert during regulatory authority inspections is desired.
• Knowledge of equipment, methods, procedures, and data interpretation required for aerosol testing, solid state analysis, and chemical analysis applied to inhalation dose forms.
• Know how/when to apply organizational policy or procedures to a variety of situations (e.g., phase-appropriate quality).
• May require travel of 5 - 10% of working time.