Senior Manager, Formulation R&D

Brief team/department description:

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 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.

As we grow and expand, we are building new capabilities to make our processes simpler, faster, and more efficient. We are looking for a dynamic, change-inspired product development Sr. Manager, to execute R&D product development projects, managing external CDMO/CMO, and managing the R&D bench scientists. The role holder will lead the product development, review technical data, prepare and review technical documents, co-ordinate with CDMO’s and CMO’s for smooth technology transfer of projects. This role aligns closely with evolving R&D needs, leveraging a strong working knowledge of pharmaceutical R&D workflows, data and applicable concepts to effectively coordinate with external vendors and internal stake holders.

Principle Responsibilities:

• Oversee all formulation activities required for supporting product development in R&D and/or CRO and/or CMO and/or CDMO.
• Review of data generated in R&D lab ensuring maintenance of data quality throughout product development and lifecycle.
• To supervise and monitor the technical development front and provide timely and accurate inputs necessary on various aspects of the ongoing programs.
• Drafting and/or review of specifications, product development reports, technology transfer protocol and reports prepared by R&D and/or CRO and/or CMO and/or CDMO.
• Review of various trial, pilot, pivotal, confirmation, submission batch documents, e.g., batch manufacturing records, process validation protocols and reports, etc.
• Draft and/or review of various CMC study protocols and reports, e.g., ICH stability study, photo-stability study, hold time study, in-use study, thermal excursion studies, and technical summary report, etc.
• Understand the different product development and tech transfer strategies in consultation with the regulatory and intellectual property requirement.
• To monitor the execution of scale-up batches and submission batches at CMO’s and to present for the batch’s execution at CMO’s if required.
• To supervise the outsourcing in co-ordination with the CFT members.
• Identify the need for regulatory license requirement for manufacturing, testing import and timely communicate such requirements to the concerned CFTs.
• Identify project needs such as equipment, instruments, manpower and escalate for their approvals.
• Carry out timely communication plan with partners and follow up for timely and accurate delivery.
• Conduct the stage gate meeting and internal review with cross functional teams to updating all the key stake holders.
• Ensure documentation compliance according to quality and regulatory requirements.
• Ensure compliance to quality and other policies/systems laid down by organization.
• Responding to all the product development queries deficiencies arising from the regulatory agencies.
• Ensure the relevant self-training in line with the organizational policies.

Qualifications and Education Requirements

• M.Pharm or Ph.D in Pharmacy with minimum industrial experience of greater than 10 years in product development and scale-up of products.
• Preferred areas 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 core area should be US.
• Experience of developing branded and differentiated products – 505(b)(2) category would be preferred.
• Experience of working with CROs/CDMOs would be preferred
• Support the Quality management system (QMS) documents such as change controls, deviations, out of specifications etc.
• Facilitate completion of required training for self and the team.