Formulation Lead

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.

Roles & Responsibilities

• Contribute to new product ideation by evaluating the technical feasibility, clinical pathway, regulatory pathway and facility requirements for the program.
• Manage and provide technical leadership to the junior formulation scientists working with the team. Monitor quality of execution, documentation, and result compilations.
• Lay down program timelines and budget for approval from ELT. Help track the program expenses with the help of finance and project management team.
• Coordinate program initiation by arranging licenses, equipment, new product introduction form, instrument, and license requirements.
• Lay down experimental strategy in consultation with delivery captain, execute the plan with the help of team members and update the relevant stakeholder on the conclusions and way forward.
• Support for provision and patent filing.
• Coordinate with clinical team for getting the required documentation and licenses in lace.
• Coordinate with PM and CRO for execution of clinical studies as per the program timelines.
• Follow the financial systems for procurement and accounting.
• Coordinate with cross functional team (regulatory, quality, packaging, quality department for alignment.
• Coordinate with quality department for relevant alignments.
• Coordinate with analytical counterparts for routine and key deliverable activities.
• Coordinate with PLM team with the help of delivery captain for program management related decision makings.
• Support alliance management for evaluation of partners and contracts.
• Manage communications with and monitor activities at external partner sites. Ensure to get the things done as per the program timelines and in compliance with quality and regulatory requirements.
• Work ahead of time for planning and executing the tech transfer, clinical studies, submission preparation and query responses.
• Coordinate for deficiency response in time.
• Ensure compliance to documentation and other procedures.
• Ensure training for self and team members.
• Keep product updated as per the system for better visibility to the department, cross functional teams and management.
  
  

Qualifications And Education Requirements

• M. Pharm or Ph.D. in Pharmacy with minimum industrial experience of 3 to 7 years in pharmaceutical development and scale-up of products.
• Preferred area of expertise is Modified Release Oral Dosage forms and/or 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.
• Should be well versed with Microsoft office applications.
  
  

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