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
Our Formulation R&D team at Azurity lend Scientific Expertise and diligence to the program/s. Manage timelines and product deliverables. Develops unique product formulations / platforms that meet the specifications of TPPs in providing innovative, high-quality medicines that serve overlooked patients.
We have an exciting opportunity—the person we select for this role will play a key part in Azurity’s scientific excellence, contribution to patient care and growth of business.
Role Title: Asst. Manager/ Deputy Manager (Experience: 7 to 10 years)
Role Reports to: Tech Lead and Delivery Captain
Principle Responsibilities
- Perform formulation development activities on differentiated formulations and innovative technologies to achieve Product development with adherence to timelines while ensuring good lab and documentation practices.
- Carry out /Support Scientific literature search (Articles/patents/publications/books) and compilation of experimental data, which will facilitate decision making to achieve Product development.
- Support drug product ideation and selection activities with technical due diligence with appropriate development approaches and assessing timelines.
- Perform Formulation optimization with special focus on manufacturability and biopharmaceutical properties of drug products to achieve successful commercial drug product.
- Carryout & Support Writing and Review of protocols, reports, validation plans and development report to achieve product development in compliance with quality systems. Coordinate with CFT’s and timely escalation to ensure document approvals on time.
- Support drug product ideation and selection activities with technical due diligence with appropriate development approaches and assessing timelines.
- Coordination with the cross functional teams (CFTs) like Analytical Development, Quality Assurance, Regulatory Affairs, etc.
- Support in preparing formal correspondence with regulatory agency to get clarity for focused efforts.
- Support in preparing milestone wise timelines for the allocated programs.
- Ensure timely execution and delivery of each program milestones and minimize the slippages.
- Prepare and review Standard Operating Procedures (SOPs), Technology Transfer Document (TTD), and other technology transfer related documents.
- Ensure the activities are carried out in compliance with various quality, regulatory and EHS norms.
- Support and coordinate application of various regulatory licenses required for R&D, clinical, import activities. Ensure timely availability of such licenses.
- Support in Developing, maintaining, and upgrading lab facility and support facility team to maintain and run lab effectively.
- Support in Technical troubleshooting/ root cause identification/ Investigation/Corrective Action and Preventive Action pertaining to product development or manufacturing activities.
- Travel Required
Qualifications And Education Requirements
This section should include relevant qualifications and education requirements.
- M. Pharm or Ph.D. in Pharmacy with minimum industrial experience of 6 to 10 years in pharmaceutical development and scale-up of products.
- Preferred area of expertise is Immediate Release/Modified Release Solid 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
