Senior Scientist, Formulation & Self-Delivery Devices

Implaion Recruiting

Durham (NC)

In loco

USD 110.000 - 160.000

Tempo pieno

14 giorni+

Generatore di candidature

Aumenta le possibilità di ricevere una risposta da questo datore di lavoro — un curriculum e una lettera di presentazione personalizzati, che corrispondono esattamente a ciò che sta cercando.

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Descrizione del lavoro

Implaion Recruiting seeks a Senior Scientist in Formulation Sciences to develop formulations for clinical and commercial product manufacturing. You will partner with external companies to advance device-delivery systems and interface with CDMOs for manufacturing in vial and device forms for global clinical sites.

The role is onsite in Durham, NC, with emphasis on pre-formulation, formulation development, and regulatory readiness across CMC.

Competenze

Ph.D. in a related field with formulation development in pharma/biotech (1-3 years) or B.S./M.S. with 5-8 years of formulation experience.
Experience developing formulations for protein therapeutics, including high concentration liquid presentations.
Knowledge of stability data, forced degradation study design and interpretation.
Experience with analytical/biophysical instrumentation used in formulation development.
Experience authoring technical reports; regulatory documentation contributions.
Ability to bring in new technology to streamline formulation development.
Proficiency with JMP or Minitab and DOE approaches for formulation development.
Understanding regulatory expectations for biopharmaceutical drug product development.

Mansioni

Lead pre-formulation and formulation development activities for drug substance and product.
Interface with external companies to screen and qualify pre-filled syringe systems and devices.
Design stability studies, oversee lab work, and review third-party data.
Develop analytical methods to characterize formulation performance; assess stability and viscosity.
Analyze data, interpret results, and support regulatory submissions and process transfer.
Lead or support fill-finish development, scale-up, and technology transfer.
Collaborate with CDMOs and cross-functional teams across development stages.

Formazione

Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Biological Sciences, or related with 1-3 years formulation development experience

B.S./M.S. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Biological Sciences, or related with 5-8 years formulation development experience

Formulation development for protein therapeutics (high concentration)

Data analysis with JMP or Minitab; DOE approaches

Regulatory knowledge: ICH, USP, FDA expectations for biopharmaceuticals

Experience authoring technical reports; CMC documentation

Sterile fill-finish operations and scale-up experience

Collaboration across cross-disciplinary teams