Job 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 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.

Brief team/department description:

Azurity develops unique, accessible, and high-quality medications, to serve overlooked patients. This role is with Azurity R&D project management team, which coordinates cross-functional planning, development and tracking of project plans, considering time, cost, quality and strategy.

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 project manager, to lead R&D process improvement initiatives, managing external vendors, utilizing tools and technology. The role holder will lead cross-functional initiatives to enhance R&D productivity and streamline product development processes through targeted process improvements, tool evaluation, and vendor coordination. This role acts as the functional lead to ensure that technology-enabled solutions align 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, internal data science and digital teams. This role focuses on functional leadership and facilitation

Principle Responsibilities:

1. R&D Laboratory Data Enablement (Functional Leadership)

• Act as the primary liaison between R&D teams and external partners in defining functional requirements related to laboratory data handling, document management, and experiment capture systems (e.g., ELN, DMS).
• Coordinate evaluation and refinement of existing R&D data processes, ensuring consistent accessibility and usability of laboratory data to support product development reviews.
• Drive functional oversight on integration projects involving lab systems (e.g., linking ELN with analytical platforms like Empower), ensuring alignment with R&D workflows.
• Define and monitor service expectations from external vendors via functionally aligned SLAs based on R&D user needs. Provide continuous feedback to vendors to ensure tools evolve with R&D processes, without taking direct ownership of the digital systems.
• Utilize a foundational understanding of available tools and data capabilities to translate scientific requirements into technical specifications and to effectively manage collaboration with external vendors and data tool providers.

2. Strategic Process Improvement in Product Development

• Partner with cross-disciplinary teams to identify key R&D pain-points and opportunities for process optimization, aligned with scientific and technical objectives.
• Lead evaluation and deployment of off-the-shelf or custom-built tools that support modeling, prediction, and experimental design workflows:
  • pk modeling platforms
  • Design of Experiments (DoE) toolkits
  • Scale-up predictors (mapped per dosage form – oral liquids, parenterals)
  • Stability prediction tools
• Ensure that tool requirements are defined from a functional and scientific standpoint, while collaborating closely with external vendors, and internal teams who manage technical implementation.

3. Functional Oversight of Targeted Tool Enablement

• Collaborate with R&D scientists to define specifications for tools that address key functional gaps such as:
  • Literature search within validated scientific databases
  • Standardized product development reports
  • Stability protocol digital workflows
• Facilitate vendor collaboration to ensure that tool outputs are scientifically accurate and contextually relevant to formulation and process teams
• Champion the evaluation of cutting-edge data tools and data-enabled solutions by working alongside internal digital, data science and technical teams to ensure deliverables meeting R&D’s strategic goals.

Qualifications and Education Requirements

• Bachelor or master’s with 3-5 years of experience in working with laboratory data handling, document management, and experiment capture systems (e.g., ELN, DMS, empower). A certification or course completion, relevant to data mgmt, structuring, dashboarding is preferred.
• Industry and Domain knowledge: Pharmaceutical R&D process, collaboration with R&D/medical/regulatory/mfg. teams to solve challenging problems through modelling / simulation eg: pk modeling, Design of Experiments (DoE), Scale-up prediction, Stability prediction. Hands-on experience in selection, evaluation and management of tool / service providers.

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.