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.
Brief team/department description:
The Formulation Development department in the science organization at Azurity pharmaceuticals is responsible for developing the new dosage forms for Serving Overlooked Patients.
Principle Responsibilities:
- To perform the literature search for drug product development.
- To develop, and optimize the product composition, manufacturing process for the oral drug products based on QbD principles.
- To Identify the studies required at the development stage of oral drug products.
- To conduct the laboratory experiments for the oral drug products, along with flawless documentation.
- To author the specifications and the justification of specifications.
- To oversee the technology transfer of the drug products and to execute scale-up batches.
- To author the QbD documents, product development reports and study protocols and reports for the product development.
- To monitor the submission batches at plant scale.
- To envisage the requirements of product development at each stage of the product life stage i.e., licensing requirements, material procurements, handling logistics.
- Co-ordination with the cross functional departments- analytical, QA, PMO, SCM etc.
- Should have good understanding of the patents, and intellectual property management. · Should have good understanding of the good documentation practices, good manufacturing practices.
- Should have good understanding of current regulatory guidelines and requirements for submissions e.g. ICH, Guidance for industry, PSG etc.
Qualifications and Education Requirements
- M. Pharmacy with 8-12 years of experience in oral solid (or liquid) product development, technology transfer.
- 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
