Formulation Development Scientist

TMC Acquisition LLCNicholasville, KY
8d

About The Position

Tailor Made Compounding, established in 2016, has quickly grown into one of the nation’s leading 503A compounding pharmacies—recognized for our innovation, precision, and deep expertise in areas like men’s health, women’s health, and IV therapy. As a fast-paced, high-growth organization, we thrive on solving complex challenges in pharmaceutical compounding and delivering personalized solutions where standard medications fall short. To support our continued growth and expanding product portfolio, we are seeking a Formulation Development Scientist who will play a critical role in advancing our formulation development capabilities. Position Overview The Formulation Development Scientist will lead formulation development efforts for sterile and non-sterile compounded preparations, with a primary emphasis on sterile dosage forms. This role owns key scientific components of the formulation lifecycle—from feasibility and compatibility through stability program management—while working closely with third-party analytical laboratories for stability and other testing needs. This role will be a central contributor to product development initiatives, partnering cross-functionally with Quality, Operations, and Pharmacy teams to develop and improve compounded preparations that are compliant, scalable, and clinically relevant within a 503A compounding pharmacy environment. The individual will also collaborate with key clinic partners seeking new products, supporting technical discussions, gathering requirements, translating clinical needs into feasible formulations, and helping guide development priorities.

Requirements

  • Advanced degree (PharmD, PhD, or equivalent) or Master’s degree with significant formulation development experience
  • Sterile compounding and formulation expertise
  • Experience with third-party analytical labs
  • Knowledge of USP standards
  • Strong communication and documentation skills

Responsibilities

  • Sterile & Non-Sterile Formulation Development Lead sterile injectable formulation development, including feasibility, compatibility, and optimization
  • Support non-sterile development as needed
  • Support development of Master Formulation Records (MFRs)
  • Stability Program & Third-Party Lab Oversight Own the stability program for compounded preparations
  • Coordinate third-party lab testing and review stability data
  • Support vendor qualification and oversight
  • Clinic Partner & Product Development Collaboration Engage clinic partners on new product concepts
  • Translate clinical needs into formulation strategies
  • Support product roadmap and prioritization
  • Quality & Compliance Alignment Ensure compliance with USP <795>, <797>, <800>
  • Support inspections and audits
  • Train staff on formulation best practices
  • Cross-Functional Support Collaborate with internal teams
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service