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Formualtion development manager

3 months ago

Chennai, Tamil Nadu, India Exapilog Private limited Full time

Title: Associate Director, Formulation R&D

Position Summary: As the Associate Director of Formulation R&D, you'll spearhead the pre-formulation and formulation design and development processes for pre-clinical and clinical development candidates. This role entails steering the formulation development function, essential for the success of our discovery and development initiatives. Collaboration with vendors to provide technical guidance, leading pre-formulation and clinical formulation design, characterization, and CMC activities are pivotal. Reporting to the VP.

Your responsibilities encompass:

  • Serving as a drug product subject matter expert for program teams across all development phases.
  • Developing the Pharmaceutical R&D function, bolstering technical capabilities, and optimizing workflows.
  • Collaboratively managing and offering technical guidance to CROs and CMOs in research and development, ensuring alignment with schedules.
  • Leading the establishment of product specifications and implementing quality control strategies.
  • Providing insights on program development strategies, budgets, and timelines to meet both technical and business requirements.
  • Acting as a scientific or project lead, including conducting due diligence assessments.
  • Facilitating communication between the company and external collaborators.
  • Cultivating and nurturing strong relationships with internal Development and Discovery functions.
  • Serving as a CMC reviewer and Subject Matter Expert for regulatory submissions.

Minimum Qualifications:

  • Master in Pharmacy
  • 5-10 years of experience in Formulation and Pharmaceutical Development within the biotech/pharmaceutical industry.
  • Strong leadership and management abilities.
  • Exceptional decision-making skills and critical thinking.
  • Excellent communication, problem-solving, and organizational skills, thriving in cross-functional teams.
  • Extensive experience in formulation development across diverse molecules and development stages, including performance qualification and regulatory submissions.
  • Proficiency in GxP practices, ICH guidelines, and regulatory practices.
  • Thorough knowledge of pharmaceutical science literature and emerging research areas.
  • Familiarity with analytical methods and instrumentation for API characterization.
  • Understanding of chemical and physical properties relevant to formulation and drug delivery.
  • Experience with Design of Experiments (DOE), Quality by Design (QbD), Process Analytical Technology (PAT), scale-up, and process technologies.

Preferred Qualifications:

  • Experience in small molecule formulation R&D across multiple administration platforms, including IV, subcutaneous, oral, and topical.