Formulation Scientist
Insud Pharma
LEON (GENHELIX), León, ES
hace 1 día

Specific Responsibilities

  • Management of formulation activities from the earlier development to process scale up (I) with demonstrated successful track record (II, III).
  • Design pre-formulation screening studies, stability studies, forced degradation studies, drug product device testing studies and in-use drug product stability studies.(II, III).
  • Leads activities of stabilities studies (long term, stress, accelerated and force degradation) (III).
  • Assist in drug product development / fill & finish activities.
  • Develops and optimizes buffer formulations.
  • Reporting and keeping updated project activities and redaction of Standards Operating Procedures, development and qualification reports.
  • Prepare technical reports timely and efficiently, including presentation of data in group meetings.
  • Designs experiments, analyzes data, and draws conclusions. Ensures accurate and complete documentation of lab activities to ensure appropriate regulatory submission.
  • Writes technical reports for tech transfer and regulatory submission.
  • Implements QbD (quality by design) approaches and utilize DoE (design of experiment) for experimental planning, data analysis and development.
  • Working according to GLP standards.
  • Continuous Improvement - will support process improvements throughout the development process.
  • Requirements and personal skills

  • Education : Degree in Chemistry, Pharmaceuticals, Biochemistry or Biology. Phd is a plus.
  • Languages : Fluent Spanish and English, knowledge of other languages will be an asset.
  • Experience (years / area) : 1-3 years of analytical experience relevant to the role. A hands-on analytical background is required, with previous experience in standard protein analytical techniques (SDS-PAGE, CE-SDS, IEF, cIEF, RP-HPLC, SEC, IEx-HPLC, HIC) to evaluate protein formulated product.
  • Specific Knowledge : Previous knowledge and hands-on experience with biophysical characterization techniques including DLS is a plus, including sub-visible particulate analysis by MFI.
  • Travels : Not required.
  • Personal skills : Ability to work successfully under appropriate supervision using scientific judgment and professional competency.
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