Assistant Manager/Sr Specialist - Formulation R&D

Azurity Pharmaceuticals is a privately held specialty pharmaceutical company dedicated to developing innovative products that address the needs of underserved patients. With a strong focus on patient-centric solutions, Azurity offers a broad commercial portfolio and a robust late-stage pipeline across therapeutic areas such as cardiovascular, neurology, endocrinology, gastrointestinal, institutional, and orphan markets. The company leverages its integrated capabilities and extensive partner network to deliver unique, accessible, and high-quality medications that have positively impacted millions of patients worldwide.

The Formulation R&D team at Azurity’s Hyderabad location plays a critical role in driving scientific innovation and ensuring timely delivery of product development programs. This team develops unique formulations and platforms aligned with Target Product Profiles (TPPs) to create high-quality medicines for overlooked patient populations. We are currently seeking a motivated Formulation Scientist with 3 to 7 years of experience to join this dynamic team and contribute significantly to Azurity’s digital transformation initiatives.

Key Responsibilities:
- Conduct formulation development activities on differentiated formulations and innovative technologies, ensuring adherence to timelines and compliance with good laboratory and documentation practices.
- Perform laboratory trials and stability studies on formulations.
- Review and compile experimental data accurately.
- Document experiments and data in the Electronic Laboratory Notebook (ELN).
- Support scientific literature searches, including articles, patents, publications, and books, to inform decision-making during product development.
- Write and review protocols, reports, validation plans, and development reports in compliance with quality systems. Coordinate with cross-functional teams (CFTs) and escalate issues to ensure timely document approvals.
- Collaborate with teams such as Analytical Development, Quality Assurance, and Regulatory Affairs to facilitate smooth project execution.
- Assist in preparing milestone-wise timelines for assigned programs and ensure timely completion of deliverables while minimizing delays.
- Prepare and review Standard Operating Procedures (SOPs), Technology Transfer Documents (TTDs), and other technology transfer-related documentation.
- Ensure all activities comply with quality, regulatory, and Environmental Health and Safety (EHS) standards.
- Support the application and timely procurement of regulatory licenses required for R&D, clinical trials, and import activities.
- Aid in developing, maintaining, and upgrading laboratory facilities, working closely with the facility team to ensure efficient lab operations.
- Participate in technical troubleshooting, root cause analysis, investigations, and implementation of corrective and preventive actions related to product development or manufacturing.

Required Qualifications:
- A degree in Pharmacy (Pharm) or a Ph.D. in Pharmacy with a minimum of 3 years of industrial experience in pharmaceutical development and product scale-up.
- Expertise in Immediate Release or Modified Release Solid Oral Dosage forms and/or Immediate Release Oral Suspensions/Solutions.
- Proficiency in Microsoft Office applications.

Preferred Qualifications and Experience:
- Experience in global product development, particularly with a focus on the US market.
- Background in developing branded and differentiated products, especially within the 505(b)(2) regulatory pathway.
- Experience working with Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs).

Applicants should confirm they are mentally and physically capable of performing the job responsibilities without restrictions. Any concerns or disabilities that may affect job performance should be communicated to Human Resources in advance.

Azurity Pharmaceuticals is an inclusive employer and Equal Opportunity Employer that values dedication, integrity, and creativity. We welcome highly motivated individuals who share our commitment to improving patient lives through scientific excellence and quality.