Manager/Senior Manager, Pharmaceutics and Drug Product

About the role

You will be an integral part of Relay’s drug product development team supporting Relay's research and development programs. You will collaborate with biology, medicinal chemistry, DMPK, and toxicology to execute scientific studies of discovery compounds in alignment with technical goals of the program.

Responsibilities

• Lead and manage formulation development activities to support pre-clinical research and early clinical stage programs independently.
• Design and develop fit-for-purpose discovery formulations of investigational compounds to enable required scientific (biology, pharmacology, animal PK/Tox etc.) assessments.
• Design and execute pre-formulation and formulation development studies to support initial clinical formulation and IND filing.
• Conduct in-use and R&D stability studies (chemical, physical, thermal and photo-stability) to support advancement of discovery compounds.
• Coordinate with drug substance, DMPK, toxicology and analytical, to ensure timely manufacture, release and supply of formulations to support dose range finding (DRF) and GLP studies.
• Collaborate with drug discovery groups (Medicinal Chemistry, Biology, DMPK, Toxicology) to develop formulation protocols for their respective studies including DRF and GLP studies.
• Design, develop and execute plans for manufacturing, testing, and analysis of pre-clinical and early-stage clinical formulations/drug products at CRO's/CDMO's.
• Collate, interpret and present scientific data in technical meetings and provide guidance/recommendations on topics and technical challenges related to formulation/drug product development.
• Design and execute polymorph and salt screening studies for selected candidate compounds and recommend the most suitable form for pharmaceutical development.
• Perform developability risk assessment of investigational compounds selected for clinical development.
• Monitor, evaluate completion of tasks and projects, present summaries/updates to management.

Requirements

• 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.

Skills

• Hands-on experience with fit-for-purpose preclinical and clinical formulations using traditional methods such as solutions, suspensions, emulsions, tablets, and capsules.
• Hands-on experience in formulation development of poorly soluble compounds using various approaches such as solid dispersions, nano-suspensions, lipid formulations, and particle size reduction techniques.
• Hands-on experience and thorough understanding of analytical techniques such as HPLC, UPLC, UV-visible, IR, PXRD, DSC/TGA, DVS, GC, KF, particle size analysis, SEM, etc.
• Strong understanding of pharmaceutics, including physicochemical properties/profiling of compounds, pharmacokinetics, and biopharmaceutics principles and their application to drug product formulation development.
• Experience with PBPK modeling and in silico models is a plus.
• Ability to multi-task and prioritize assignments, operational creativity, strong problem-solving skills, self-motivated, and able to work under pressure.
• Exceptional attention to detail, follow-up/through skills; ability to work individually and within multi-disciplinary internal and external teams at third parties.
• Proven ability to collaborate effectively across internal and external stakeholders.
• Excellent written and verbal communication skills with strong problem-solving capabilities.

Pay

Estimated salary range: $122,000 - $174,000. The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills, and location.