Assistant Manager, Formulation R&D

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: Assistant Manager /Dy. Manager, Formulation R&D (Experience: 6 to 9 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.
• 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.
• 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.

• Pharm in Pharmacy with minimum industrial experience of 6 to 9 years in pharmaceutical formulation development.
• Preferred area of expertise is Immediate Release/Modified Release/Controlled release/ Solid Oral Dosage forms (Tablets/Capsules/ODT/PFOS/Granules/MUPS) and/or Immediate Release Oral Suspensions/Solutions.
• Preferred area of expertise in handling complex and super complex dosage forms.
• 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.
• Should be well versed with Microsoft office applications.
  
  

By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.