Scientist/Sr. Scientist, Formulation R&D

Brief team/department description:

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 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.

As we grow and expand, we are building new capabilities to make our processes simpler, faster, and more efficient. We are looking for a dynamic, change-inspired product development scientist, to execute R&D product development projects as a bench scientist. The role holder will lead the product development, review technical data, prepare and review technical documents, co-ordinate with CDMO’s and CMO’s for smooth technology transfer of projects. This role aligns closely with evolving R&D needs, leveraging a strong working knowledge of pharmaceutical R&D workflows, data and applicable concepts to effectively coordinate with external vendors and internal stake holders.

Principle Responsibilities:

• Design, conduct and or supervise formulation development, process development, process optimization, scale up and manufacturing of product.
• 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.
• Review of test results in alignment with the project goals, identify causes of variances and recommend solutions to achieve goals.
• Schedule experiments and prioritize assignments to meet project objectives and deadline.
• Maintain laboratory equipment and follow company safety standards.
• Conduct laboratory experiments and prepare reports with conclusions and recommendations.
• Follow current laboratory procedure and develop new laboratory procedures or improvise existing procedures to meet project objectives.
• Identify and manage the potential risks within complex projects in a timely fashion.
• Record accurate and complete experimental methods and results in compliance with good documentation practices.
• Act as primary scientific contact to external collaborators.
• Check and manage inventories of supplies and raw materials.
• Ensure the relevant self-training in line with the organizational policies.

Qualifications and Education Requirements

• M.Pharm or Ph.D in Pharmacy with minimum industrial experience 5-10 years in product development and scale-up of products.
• Preferred areas of expertise is Extended and Sustained Release Oral Solid Dosage forms and Extended and Sustained Release Suspensions (Dry or Liq.) and Immediate Release Oral Suspensions/Solutions.
• Global Product Development Experience is preferred while core area should be US.
• Experience of developing branded and differentiated products – 505(b)(2) category would be preferred.
• Experience of working with CROs/CDMOs would be preferred
• Support the Quality management system (QMS) documents such as change controls, deviations, out of specifications etc.
• Facilitate completion of required training for self