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Director Formulation Cmc Jobs (NOW HIRING)

Codera

Director, CMC - Formulations

San Diego, CA · Remote

$190K - $260K/yr

Position Summary The Director, CMC - Formulations will contribute to the oversight, planning and ... Research CMC and formulation topics to support Tang Capital's investments * Participate in business ...

Codera LLC

Director, CMC - Formulations

San Diego, CA · On-site

$190K - $260K/yr

Position Summary The Director, CMC - Formulations will contribute to the oversight, planning and ... Research CMC and formulation topics to support Tang Capital's investments * Participate in business ...

Eli Lilly and Company

Senior Director, Drug Product CMC

$238K - $249K/yr

Support clinical formulation development of oral solid dosage forms, as needed. * Author and/or ... The Senior Director Drug Product CMC role is based in the US, with occasional travel. Lilly is ...

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Associate Director, Formulation Development

Burlington, MA • On-site

Scorpion Therapeutics
51 - 200 employees
Learn more about Scorpion Therapeuticsexternal

Other

Posted 8 days ago

Job description

Associate Director, Formulation DevelopmentKey Responsibilities
  • Lead and contribute to the design, development, and optimization of pharmaceutical formulations for peptide therapeutics.
  • Oversee formulation development laboratory activities.
  • Support implementation of analytical methods for characterizing peptides, including chromatographic, spectroscopic, and physical characterization.
  • Oversee and ensure robust QC procedures and compliance with regulatory guidance and industry standards (e.g., ICH guidelines).
  • Plan and conduct non-GMP stability studies; contribute to GMP stability study design to assess shelf-life and degradation pathways.
  • Lead and contribute to drug product process optimization studies to enhance performance and manufacturability at scale; contribute to process transfer to CDMOs.
  • Identify and address formulation and analytical technical challenges (e.g., design experiments, root cause analyses).
  • Partner with Regulatory personnel to incorporate formulation/analytical data into regulatory documents.
Education & Qualifications (Required/Preferred)
  • BS/MS/PhD in pharmaceutical sciences, analytical chemistry, biochemistry, or related field; 8+ years relevant industrial experience emphasizing formulation and analytical development.
  • In-depth understanding of peptide physicochemical stability and experience optimizing parenteral (liquid and lyophilized) formulations.
  • Combination products/devices experience highly desirable.
  • Hands-on analytical methods experience (SEC, RP-HPLC, LC-MS, subvisible particle analysis).
  • Experience in lyophilization formulation, cycle development, and analytical testing.
  • Familiarity with end-to-end CMC drug development, critical milestones, and bottlenecks.
  • CMC regulatory knowledge for parenteral drugs (e.g., FDA, EMA).
  • Strong self-starter, analytical/problem-solving skills, communication, and organizational/multitasking ability in a fast-paced environment.
Travel
  • Periodic travel as needed by the business, including attendance at Together Weeks, Together Days, and functional meetings.
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