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Formulation Development Scientist
Formulation Development ScientistTMC Acquisition LLC • Nicholasville, KY, US
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Formulation Development Scientist

Formulation Development Scientist

TMC Acquisition LLC • Nicholasville, KY, US
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  • [job_card.full_time]
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Job Description

Job Description
Salary: DOE

Tailor Made Compounding, established in 2016, has quickly grown into one of the nations leading 503A compounding pharmaciesrecognized for our innovation, precision, and deep expertise in areas like mens health, womens 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 lifecyclefrom feasibility and compatibility through stability program managementwhile 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 alsocollaborate with key clinic partnersseeking new products, supporting technical discussions, gathering requirements, translating clinical needs intofeasibleformulations, and helping guide development priorities.


Primary 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


Qualifications

Education & Experience (one required):

  • Advanced degree (PharmD, PhD, or equivalent)
    or
  • Masters degree with significant formulation development experience

Core Skills

  • Sterile compounding and formulation expertise
  • Experience with third-party analytical labs
  • Knowledge of USP standards
  • Strong communication and documentation skills

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Formulation Development Scientist • Nicholasville, KY, US

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