Delivery Captain Formulations R&D

As a pharmaceutical company dedicated to providing innovative products for underserved patients, Azurity Pharmaceuticals offers a broad range of patient-centric medications across various markets. The company values inclusivity and is committed to creating an equal opportunity workplace. Azurity's success is driven by a talented and dedicated team focused on improving patients" lives through quality and scientific innovation. - Assist in product ideation and selection activities, conducting technical due diligence, assessing feasibility, and defining feasible pathways. - Identify outsourcing needs, evaluate potential partners, and recommend collaborations based on quality, time, and cost considerations. - Support in laying down legal and commercial agreements with partners, such as confidentiality agreements and pricing agreements. - Evaluate the need for consultation with external experts or regulatory agencies for focused efforts. - Establish milestone timelines for programs, communicate decision-making milestones, and drive timely execution of program milestones. - Conduct internal reviews to update key stakeholders on program status, delays, and suggest readjustments. - Support annual budget preparation, monitor budgetary spends, and provide estimates for unforeseen expenditures. - Monitor product development activities, ensure compliance with quality, regulatory, and EHS norms, and identify program needs for equipment and licenses. - Actively monitor outsourced activities, provide technical inputs, and facilitate alignment on technical, quality, and financial matters. - Perform technical troubleshooting, root cause identification, and corrective actions related to product development or manufacturing activities. - Ensure development meets regulatory requirements and facilitate timely submissions. Qualifications Required: - M.Pharm or Ph.D. in Pharmacy with over 15 years of industrial experience in product development. - Expertise in Extended and Sustained Release Oral Solid Dosage forms and Immediate Release Oral Suspensions/Solutions. - Global Product Development Experience, preferably in the US market. - Experience in developing branded products in the 505(b)(2) category. - Proficiency in managing teams, projects, and end-to-end lifecycle management of products. - Familiarity with working with CROs/CDMOs is preferred.,