Delivery Captain – Formulations R&D

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

Education and Experience

• M.Pharm or Ph.D. in Pharmacy with minimum industrial experience of greater than 15 years in product development and scale-up of products.
• Preferred area of expertise is Extended and Sustained Release Oral Solid Dosage forms and Extended and Sustained Release Suspensions (Dry or Liq.) and Immediate Release Oral Suspensions/Solutions.
• Global Product Development Experience is preferred while the core area should be the US.
• Experience of developing branded and differentiated products – 505(b)(2) category would be preferred.
• Experience of working with CROs/CDMOs would be preferred.
• Experience in managing teams and projects and having experience in end-to-end lifecycle management of products is preferred.

Roles & Responsibilities

• Assist product ideation and selection activities with technical due diligence on feasibility within IP constraints, assessing timelines, and patentability evaluations with IP department, making ballpark budgetary estimates, evaluating outsourcing versus in-house developmental options, defining feasible TPP, clinical, and regulatory pathways by consulting with respective internal or external stakeholders.
• Identify needs for outsourcing. To facilitate the identification of the right partner, provide all detailed scope of work/services / material requirements to alliance manager. Evaluate the various identified partners based on quality, time, cost, and prior experience and make recommendations.
• Support laying down various legal and commercial agreements with partners such as confidentiality disclosure agreement, master service agreement, pricing agreements, cost change orders etc.
• Evaluate and recommend need for consultation with external subject matter expert or a formal correspondence (Pre-IND, Pre-NDA, IND, Pre-ANDA, Controlled correspondences) with Agency to get clarity for focused efforts.
• Lay down milestone wise timelines for the allocated programs in consultation with cross functional teams. Identify and communicate various decision-making milestones during the lifecycle of a program.
• Drive timely execution and delivery of each program milestones. Effectively communicate with internal stakeholders, provide timely and accurate inputs or escalations on various aspects to minimize the slippages.
• Carry-out necessary internal reviews with ELT and CFTs to ensure that all key-stake holders are updated about the status of the program and possible delays with suggestions for readjustments and its impact on overall program timelines.
• Support annual budget preparation for allocated programs based on the estimates and understanding of various developmental, technology transfer, consultation, clinical etc costs.
• Monitor budgetary spends with the help of finance team. Provide timely estimates for unavoidable, unforeseen expenditures and take due approval for such spends by providing justifications.
• Monitor product development activities at the Slayback R&D centers. With the help of R&D team, ensure the activities are carried out in compliance with various quality, regulatory and EHS norms.
• Timely identify program needs such as equipment, instruments, manpower, facility modification and communicate recommendations to get necessary approvals from management.
• Identify need of various regulatory licenses required for R&D, clinical, import activities. Timely providing inputs to the concerned department, follow up, escalate to ensure timely availability of such licenses.
• Actively monitor outsourced activities at the partner site by a regular communication plan. Provide timely technical inputs and decisions for successful task completions. Facilitate alignment on technical, quality and financial matters between the cross functional teams of respective companies.
• Technical troubleshooting/ root cause identification/ Investigation/Corrective Action and Preventive Action pertaining to product development or manufacturing activities.
• Ensure the development is adequate fulfilling recommended regulatory requirements provided by the respective department to facilitate timely submission and minimizing deficiencies. Identify need for rationalization of regulatory needs and facilitate decision making by providing right inputs to CFT and management.

Physical & Mental Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Must be able to sit for long periods of time
• While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
• May occasionally climb stairs and/or ride elevators
• The employee must occasionally lift and/or move up to 25 pounds
• Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
• Other miscellaneous job duties as required