Scientific Formulations Manager

5 days ago


Hyderabad, Telangana, India Aragen Bioscience Full time
Job Title:

Principal Scientific Manager

Job Description:

Main Responsibilities:

  • Lead Formulations and Processes: Develop, evaluate, and optimize robust formulations and processes for immediate release and modified release tablet and capsule dosage forms.
  • Patent Evaluation and Strategy Development: Conduct patent research and develop non-infringement strategies to bring Paragraph IV products to market.
  • Scale-up and Technology Transfer: Scale-up and optimize manufacturing processes, execute pre-exhibit and exhibit batches, and transfer technology from R&D to production to meet project timelines.
  • Project Planning and Execution: Plan and contribute to project-related scientific/technical activities, including interpreting results, assessing data, drawing conclusions, and writing reports.
  • Document Authorship: Author technical documents, such as Product Development Reports and Quality Overall Summaries, for regulatory filing purposes.
  • Collaboration and Communication: Interact with API manufacturers, CROs, and CMOs as needed, and work proactively with cross-functional groups to execute change controls.
  • Quality and Compliance: Create and review SOPs, review documentation and test results for accuracy and completeness, and ensure compliance with SOPs/GMP requirements.
  • Regulatory Affairs Support: Coordinate with RA for filing ANDAs and addressing deficiencies, and provide relevant documents in a timely manner for ANDA filings and Supplements.
  • Batch Record Review: Review batch records, process characterization reports, validation reports, and investigation reports to ensure quality and compliance.

Required Qualifications:

  • Education and Experience: Masters with a minimum of 15 years or a Ph.D. in Pharmacy with a minimum of 5 years of relevant experience in oral solids product development in the generic pharmaceutical industry. Generic R&D experience and successful track record of AND submissions are essential. Experience with modified release dosage forms is a plus.
  • Skills and Abilities: Self-motivation, excellent written and verbal communication skills, good interpersonal and project management skills are critical for this position.

Key Functions:

  • Oral Solid Dosage Forms Development: Responsible for developing stable, bioequivalent, and manufacturable generic solid oral formulations.
  • Literature Search and Pre-Formulation: Conduct literature searches and perform pre-formulation studies to support formulation design and development.


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