Executive/Junior Manager, Formulation R&D
Mareedpally, Telangana, India دوام كامل
كن أول من يتقدم بطلب
- خبرة
- 4–6 yrs
- مرتب
- —
- الوظائف الشاغرة
- 1
- تم النشر
- ستارة
Where you'll work
المسمى الوظيفي
About Azurity Pharmaceuticals
Azurity Pharmaceuticals is a privately owned specialty pharmaceutical organization dedicated to creating innovative medicines for patients whose needs are often overlooked. The company is known for accessible, high-quality products and uses its integrated strengths and partner ecosystem to grow a broad commercial portfolio and an advanced late-stage pipeline. Its patient-focused portfolio spans cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan therapies, and has supported millions of patients worldwide.
Azurity is committed to building an inclusive workplace and operates as an Equal Opportunity Employer. The organization credits its progress to a skilled, committed team that puts patient benefit, scientific rigor, and quality at the center of its work. It looks for people who bring motivation, integrity, and creativity to a fast-moving environment.
Team Overview
The Formulation R&D group provides scientific depth and disciplined execution across programs. The team manages timelines, coordinates deliverables, and creates distinctive product formulations and platforms aligned to target product profiles, with the goal of delivering innovative, high-quality medicines for underserved patients.
This opening offers the chance to contribute directly to Azurity’s scientific goals, patient impact, and business growth.
Role Details
Role: Executive/Junior Manager, Formulation R&D
Experience expected: 4 to 6 years
Reporting line: Tech Lead and Delivery Captain
Key Responsibilities
- Lead formulation development work on differentiated products and novel technologies, while meeting project schedules and maintaining strong laboratory and documentation standards.
- Conduct and assist with searches across scientific articles, patents, publications, and books, and compile experimental findings to support informed development decisions.
- Contribute to drug-product ideation and selection by applying technical due diligence, selecting suitable development strategies, and estimating timelines.
- Refine formulations with emphasis on manufacturability and biopharmaceutical performance so that commercial product goals can be achieved.
- Draft, review, and support protocols, reports, validation plans, and development reports, while coordinating with cross-functional teams and escalating issues to secure timely document approval.
- Work closely with cross-functional partners such as Analytical Development, Quality Assurance, and Regulatory Affairs.
- Assist in preparing formal communications to regulatory authorities when clarification is needed to guide development efforts.
- Prepare and review SOPs, Technology Transfer Documents, and other documents related to technology transfer.
- Ensure all work aligns with applicable quality, regulatory, and EHS requirements.
- Support the preparation and coordination of regulatory licenses needed for R&D, clinical, and import-related activities so approvals remain current and available on time.
- Help develop, maintain, and improve laboratory facilities, and support the facility team in operating the lab efficiently.
- Assist with technical troubleshooting, root-cause analysis, investigations, corrective actions, and preventive actions related to development or manufacturing issues.
- Be open to travel as required for the role.
Requirements
- M.Pharm qualification with 4 to 6 years of industrial experience in pharmaceutical formulation development.
- Hands-on exposure to parenteral, ophthalmic, and oral liquid dosage forms such as solutions, suspensions, and emulsions is preferred.
- Preference for candidates with experience in immediate-release and modified-release solid oral dosage forms and/or immediate-release oral suspensions and solutions.
- Global product development exposure is desirable, with a primary focus on the US market.
- Experience with branded and differentiated products, especially within the 505(b)(2) category, will be an advantage.
- Strong working knowledge of Microsoft Office applications.
Additional Information
The role is based in Mareedpally, Telangana, India and is a full-time onsite opportunity.
Applicants should be capable of carrying out the responsibilities listed in the job description without restriction. If there is any physical or mental condition that could affect performance, the candidate is expected to inform HR in advance.
Travel may be required depending on business needs.