Assistant Manager/Sr Specialist - Formulation R&D

Brief team/department description:

Our Formulation R&D team at Azurity (Hyderabad) 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 digital transformation!

Role Title: Formulation Scientist (Experience: 3 to 7 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.
• Perform lab trials, stability studies of formulations.
• Perform data review and complication.
• Writing of experiments, data compilation in ELN.
• Carry out /Support Scientific literature search (Articles/patents/publications/books) and compilation of experimental data, which will facilitate decision making to achieve Product development.
• 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 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.

Qualifications and Education Requirements

• Pharm or Ph.D. in Pharmacy with minimum industrial experience of 3 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.