Senior Scientist, Formulation & Self-Delivery Devices

Implaion Recruiting; Durham (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Education

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

Tools

DLS

DSC

FTIR

Viscometers

Spectrophotometers

Particle counters

Job description

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.