Implaion

SUMMARY

• This is a drug delivery role inside the Formulation Sciences team. You'd own selection and advancement of the delivery system — prefilled syringe, autoinjector, or on-body — for a self-administered protein biologic.
• Device and combination product experience is the requirement. Hands-on selecting and advancing a delivery system for a biologic, plus the regulatory work to take it into the clinic.
• We'll coach the formulation side. Strong device background with lighter formulation depth is a trade we'll make.
• Formulation development alone isn't a fit, and neither is device design engineering — we select and qualify systems, we don't build them.

About the Position

As a Senior Scientist in Formulation Sciences, you will be an integral part of the formulation sciences team. This team is responsible for developing formulations for the clinical and commercial manufacturing of therapies. The position is also responsible for partnering with external companies to advance devices for self-administered delivery of our therapeutics to patients. The position will help interface with CDMOs specializing in drug product manufacturing operations to manufacture our drug in both vial and device form for delivery to clinical sites and eventually patients worldwide. This full-time, regular position will be located onsite in Durham, NC. The level and remuneration will be commiserate with experience.

Summary of Key Responsibilities

• Lead pre-formulation and formulation development activities for drug substance and drug product, including excipient screening, formulation optimization, and assessment of product quality attributes
• Interface with external companies to screen, identify, qualify, manufacture and supply appropriate pre-filled syringe (PFS) systems, auto-injectors and on body drug delivery systems as appropriate
• Design stability and forced degradation studies, author protocols, oversee execution at internal or external laboratories, and review data generated by third-party vendors
• Develop and apply biophysical and analytical methods to characterize formulation performance, including assessments of aggregation, thermal stability, viscosity, particulate risk, and protein higher-order structure
• Analyze samples and data, interpret results, and author or review technical reports that support formulation selection, process transfer, manufacturing readiness, and regulatory submissions
• Identify and implement technologies that improve formulation development workflows, and support transfer of formulation and drug product processes into pilot plant, CDMO, and cGMP manufacturing environments
• Evaluate container closure systems and delivery technologies for biologic drug products, including prefilled syringes, on-body delivery systems, syringeability, injectability, viscosity, dose compatibility, and particulate characterization
• Generate internal and external technical documents that support manufacturing, development decisions, and CMC sections of regulatory filings
• Lead or support drug product fill-finish development, scale-up, and transfer activities, as appropriate for program needs
• Routine interaction with Analytical Development, Downstream Process Development, Pilot Plant, Clinical, Research, Quality, Regulatory, and external partners will be essential to success in this role.
• The successful candidate will help train and mentor colleagues in formulation development, sample analysis, data interpretation, and GxP laboratory practices.
• Development of liquid formulations for protein-based therapeutics (including high concentration development)
• Collaboration with drug product CDMOs

  
  

Required Qualifications

The successful candidate will bring the following required qualifications:

• Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Biological Sciences, or a related discipline with at least 1-3 years of formulation development experience in the pharmaceutical or biotechnology industry, preferably with biopharmaceutical products, or, B.S. or M.S. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Biological Sciences, or a related discipline with at least 5-8 years of formulation development experience in the pharmaceutical or biotechnology industry, preferably with biopharmaceutical products.
• Demonstrated experience developing formulations for protein therapeutics, including high concentration liquid presentations
• Knowledge of forced degradation study design, stability protocol development, and interpretation of formulation-relevant stability data
• Broad experience with analytical and biophysical instrumentation used in formulation development, such as spectrophotometers, DLS, DSC, FTIR, viscometers, particle counters, and other tools used to assess formulation stability and drug product performance
• Experience in authoring technical reports
• Demonstrated ability to bring in new technology and processes to improve formulation development
• Experience using data analysis and statistical tools such as JMP or Minitab, including application of design of experiments approaches to formulation development
• Understanding of relevant ICH, USP, Ph. Eur., FDA, and other applicable regulatory expectations for biopharmaceutical drug product development
• Detailed knowledge of sterile fill-finish operations and scale-up, with the ability to lead development and transfer of fill-finish activities
• Demonstrated ability to work collaboratively in a laboratory environment
• Experience contributing to CMC regulatory documents, including technical summaries, justifications, and responses to regulatory questions
• Demonstrated knowledge of primary packaging materials used for sterile dosage forms, including considerations for compatibility, extractables and leachables, and container closure integrity
• Ability to collaborate with and lead cross-disciplinary teams across multiple therapeutic areas and development stages
• Experience developing high-concentration biologic formulations and evaluating viscosity, particulate formation, syringeability, injectability, and dose compatibility is strongly preferred
• Experience maintaining, troubleshooting, and qualifying formulation-related laboratory equipment is preferred