Azurity Pharmaceuticals Formulation Lead Job For Pharma – Apply Online
Formulation Lead
Location: Hyderabad
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, gastrointestinal, 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.
Roles & Responsibilities:
- Contribute to new product ideation by evaluating the technical feasibility, clinical pathway, regulatory pathway, and facility requirements for the program.
- Manage and provide technical leadership to the junior formulation scientists working with the team. Monitor quality of execution, documentation, and result compilations.
- Lay down program timelines and budget for approval from ELT. Help track the program expenses with the help of finance and project management team.
- Coordinate program initiation by arranging licenses, equipment, new product introduction form, instrument, and license requirements.
- Lay down experimental strategy in consultation with the delivery captain, execute the plan with the help of team members, and update the relevant stakeholder on the conclusions and way forward.
- Support for provision and patent filing.
- Coordinate with the clinical team for getting the required documentation and licenses in place.
- Coordinate with PM and CRO for execution of clinical studies as per the program timelines.
- Follow the financial systems for procurement and accounting.
- Coordinate with cross-functional teams (regulatory, quality, packaging, quality department for alignment).
- Coordinate with the quality department for relevant alignments.
- Coordinate with analytical counterparts for routine and key deliverable activities.
- Coordinate with PLM team with the help of delivery captain for program management-related decision making.
- Support alliance management for evaluation of partners and contracts.
- Manage communications with and monitor activities at external partner sites. Ensure tasks are completed as per the program timelines and in compliance with quality and regulatory requirements.
- Plan and execute the tech transfer, clinical studies, submission preparation, and query responses ahead of time.
- Coordinate for deficiency response in a timely manner.
- Ensure compliance with documentation and other procedures.
- Ensure training for self and team members.
- Keep products updated in the system for better visibility to the department, cross-functional teams, and management.
Qualifications and Education Requirements:
- M. Pharm or Ph.D. in Pharmacy with a minimum of 3 to 7 years of industrial experience in pharmaceutical development and product scale-up.
- Preferred expertise in Modified Release Oral Dosage forms and/or Immediate Release Oral Suspensions/Solutions.
- Global Product Development experience is preferred, with a core focus on the US.
- Experience developing branded and differentiated products, particularly in the 505(b)(2) category, is preferred.
- Experience working with CROs/CDMOs is preferred.
- Proficiency in Microsoft Office applications is required.
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