About the Role

We seek highly motivated individuals with the dedication, integrity, and a creative spirit needed to thrive in our organization. Working at Azurity offers a unique opportunity that combines the fast pace and growth opportunities of a global company with intellectual rigor and creativity. 

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.

Key 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 trials, 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 update 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.

Preferred Qualifications

• Pharm or Ph.D in Pharmacy with minimum industrial experience of 12 years in product development and scale-up of products.
• Preferred areas of expertise are IR/ER Oral Solid and Liquid Dosage forms, hands on technologies like HME, nanoparticulate, Wurster process, etc.
• Good understanding of PK/BA/BE.
• 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.