Formulation Development ( OSD Oncology)

• Experience

  : Minimum 7-10 years of hands-on experience in

  formulation and technological process development

  of various solid oral dosage forms for regulated markets such as the US, EU, and Canada.

• Formulation Strategy & Execution

  : Expertise in designing formulation and process development strategies, planning and executing activities to develop robust, scalable products within defined timelines. This includes literature reviews, pre-formulation studies, laboratory trials, and detailed documentation in electronic lab notebooks (eLNs).

• Product & Process Optimization

  : Skilled in formulation and process optimization, execution of pilot bioequivalence (BE) batches, and application of Quality by Design (QbD) principles. Familiar with bio study requirements and timelines for sample submissions.

• Cross-functional Coordination

  : Strong coordination with departments such as Analytical, Regulatory Affairs, Production, QC, Procurement, and other cross-functional teams to ensure efficient product development and execution. Involved in drafting and reviewing in-process and finished product specifications.

• Documentation & Compliance

  : Responsible for preparing protocols, technology transfer documents, stability and interim reports, and comprehensive product development reports with a focus on accuracy, compliance, and regulatory requirements (Module 3).

• Technology Transfer

  : Proficient in executing technology transfer to manufacturing sites by applying scale-up principles and supporting smooth execution at commercial scale.

• Regulatory Support

  : Experience in supervising and addressing regulatory queries is an added advantage.

• Additional Responsibilities

  : Willing to undertake additional tasks as assigned to support project success.

• Project Alignment

  : Works closely with cross-functional teams (CFTs) and aligns effectively with Project Management to meet project goals.

Must have experience in working in oncology ( anti cancer ) OSD formulation.