Formulation Development Scientist

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.

Job Responsibilities:

1. Design, conduct and or supervise formulation development, process development, process optimization, scale up and manufacturing of product.
2. Prepare and review documents such as batch records, Batch Packaging Records, Product Development reports, SOPs, Stability protocols, Raw material specifications, Packaging material specifications and In-process/ Finished product specifications, labelling and stability loading.
3. Review of test results in alignment with the project goals, identify causes of variances and recommend solutions to achieve goals.
4. Schedule experiments and prioritize assignments to meet project objectives and deadline.
5. Maintain laboratory equipment and follow company safety standards.
6. Conduct laboratory experiments and prepare reports with conclusions and recommendations.
7. Follow current laboratory procedure and develop new laboratory procedures or improvise existing procedures to meet project objectives.
8. Identify and manage the potential risks within complex projects in a timely fashion.
9. Record accurate and complete experimental methods and results in compliance with good documentation practices.
10. Act as primary scientific contact to external collaborators.
11. Check and manage inventories of supplies and raw materials.
12. Ensure completion of all the training on time.

Qualifications and Education Requirements

1. M. Pharm or Ph.D. in Pharmacy with minimum industrial experience of 3 to 6years in pharmaceutical development and scale-up of products.
2. Preferred area of expertise is oral dosage forms precisely in Modified Release/ extended release/ targeted release/immediate release solid/Suspensions/Solutions.
3. Global Product Development Experience with markets like US/EU/China/ROW.
4. Experience of developing branded and differentiated products – 505(b)(2) category would be preferred.
5. Experience of working with CROs/CDMOs would be preferred.
6. 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.