Manager/Senior Manager,Pharmaceutics and Drug Product Job Cambridge area,Massachusetts USA,Research/Development

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.

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,…

Manager​/Senior Manager, Pharmaceutics and Drug Product

Manager/Senior Manager, Pharmaceutics and Drug Product