Manager/Senior Manager, Pharmaceutics and Drug Product
$122,000–$174,000 year
On-siteCambridge, Massachusetts, United States
Job Summary
Lead and manage formulation development activities for pre-clinical research and early clinical stage programs, including designing fit-for-purpose discovery formulations and executing pre-formulation and formulation studies to support initial clinical formulation and IND filing. Conduct in-use and R&D stability studies for chemical, physical, thermal, and photo-stability while coordinating with drug substance, DMPK, toxicology, and analytical teams to ensure timely manufacture, release, and supply of formulations for dose range finding and GLP studies. Design and execute polymorph and salt screening studies, perform developability risk assessments, and manage manufacturing, testing, and analysis plans at CROs/CDMOs. Collaborate with drug discovery groups to develop formulation protocols and present scientific data in technical meetings to guide technical challenges.
Required 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 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
- 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
Desired Qualifications
- Experience with PBPK modeling, in silico models is a plus
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