Senior Manager - Drug Formulation & Development

Relay-Therapeutics; Cambridge (MA); On-site; USD 122,000 - 174,000; Full time

Job summary

Relay Therapeutics in Cambridge, MA is seeking a Manager/Senior Manager for Pharmaceutics and Drug Product to lead formulation development for preclinical and early clinical programs. You will design discovery formulations, conduct pre-formulation and stability studies, and coordinate with DMPK, toxicology and analytics to ensure timely manufacturing and study supply.

You will collaborate with cross-functional teams across science disciplines, drive developability assessments, and supervise

Qualifications

• Master’s or advanced degree in Pharmaceutics, Pharmaceutical Sciences, Chemistry or related fields.
• Minimum of 6+ years of relevant experience in early-stage formulation development for small molecules with a focus on developing oral dosage forms.
• Hands-on experience with preclinical and clinical formulations using solutions, suspensions, emulsions, tablets and capsules.
• Experience with poorly soluble compounds using solid dispersions, nano-suspensions, lipid formulations and particle size reduction.
• Thorough understanding of analytical techniques such as HPLC, UPLC, UV-Vis, IR, PXRD, DSC/TGA, DVS, GC, KF, particle size analysis, SEM.
• Strong knowledge of pharmaceutics principles and developability risk assessment.
• Excellent written and verbal communication skills.

Responsibilities

• Lead and manage formulation development activities for pre-clinical research and early clinical programs.
• Design and develop discovery formulations to enable biology, pharmacology, and animal PK/tox assessments.
• Plan pre-formulation and formulation studies for initial clinical formulation and IND filing.
• Conduct stability studies to support advancement of discovery compounds.
• Coordinate with drug substance, DMPK, toxicology and analytics to ensure supply for DRF and GLP studies.
• Collaborate with discovery groups to develop formulation protocols for their studies.
• Plan manufacturing, testing, and analysis of pre-clinical and early-stage formulations at CROs/CDMOs.
• Present data in technical meetings and provide recommendations on formulation challenges.
• Design and execute polymorph and salt screening to select suitable form.

Skills

Formulation development

Oral dosage forms

Preclinical formulation studies

Early-stage formulation experience

Analytical thinking

Cross-functional collaboration

Education

Master’s or advanced degree in Pharmaceutics, Pharmaceutical Sciences, Chemistry or related fields

Tools

HPLC

UPLC

UV-Vis

IR

PXRD

DSC/TGA

DVS

GC

KF

Particle size analysis

SEM

Job description

Relay Therapeutics in Cambridge, MA is seeking a Manager/Senior Manager for Pharmaceutics and Drug Product to lead formulation development for preclinical and early clinical programs. You will design discovery formulations, conduct pre-formulation and stability studies, and coordinate with DMPK, toxicology and analytics to ensure timely manufacturing and study supply.

You will collaborate with cross-functional teams across science disciplines, drive developability assessments, and supervise