Manager​/Senior Manager, Pharmaceutics and Drug Product

Manager/Senior Manager, Pharmaceutics and Drug Product

Cambridge, MA

The Opportunity:

• You will be an integral part of Relay's drug product development team supporting Relay's research and development programs.
• You will be responsible for design and development of pre-clinical formulations to support discovery research and enable candidate selection/nomination.
• You will be responsible for collaborating with biology, medicinal chemistry, DMPK, and toxicology to execute scientific studies of discovery compounds in alignment with technical goals of the program
• You will be responsible for developing phase-appropriate oral drug product formulations and manufacturing process to enable early-stage clinical studies.

Your Role:

• You will lead and manage formulation development activities to support pre-clinical research and early clinical stage programs independently,
• You will design and develop fit-for-purpose discovery formulations of investigational compounds to enable required scientific (biology, pharmacology, animal PK/Tox etc.) assessments.
• You will design and execute pre-formulation and formulation development studies to support initial clinical formulation and IND filing.
• You will conduct in-use and R&D stability studies (chemical, physical, thermal and photo-stability) to support advancement of discovery compounds
• You will 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.
• You will collaborate with drug discovery groups (Medicinal Chemistry, Biology, DMPK, Toxicology) to develop formulation protocols for their respective studies including DRF and GLP studies.
• You will 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.
• You will collate, interpret and present scientific data in technical meetings and provide guidance/recommendations on topics and technical challenges, as applicable, related to formulation/drug product development
• You will design and execute polymorph and salt screening studies for selected candidate compounds and recommend most suitable form for pharmaceutical development
• You will perform develop ability risk assessment of investigational compounds selected for clinical development
• You will monitor, evaluate completion of tasks and projects, present summaries/updates to management.

Your Background:

• 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 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, 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.

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…