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Senior Scientist II
2 months ago
We are seeking a highly skilled Senior Scientist II to join our team at Meet, a leading biotech company in the Oncology space. As a key member of our formulation development team, you will be responsible for driving science-based formulation development and strategy for small molecule projects from first-in-human formulations to commercial development.
Key Responsibilities- Formulation Development: Drive the development of novel formulations for small molecule projects, integrating physicochemical properties, solid-state properties, and preclinical to late-phase clinical and commercial formulations for solid oral dosages (tablets, capsules, etc.).
- Cross-Functional Collaboration: Collaborate with process chemistry, analytical, clinical supply chain, quality, logistics, and Contract Manufacturing Organizations (CMOs) for formulation development and manufacturing of Commercially Marketed (CTM) supplies.
- CMO Management: Effectively manage CMOs to meet Key Performance Indicators (KPIs) and other analytics.
- Data Preparation: Prepare and organize data for presentation to stakeholders.
- Lab Notebook Maintenance: Maintain laboratory notebooks in a complete, consistent, and concise manner in accordance with company policies.
- Health and Safety: Adhere to good health and safety practices and compliance with applicable Environmental, Health, and Safety (EH&S) rules and participate in mandatory safety training programs.
- Travel: Travel to CMOs and monitor CTM manufacturing as expected, approximately 20% of the time.
- Education: PhD in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or other relevant field.
- Experience: Minimum of 2 years of relevant experience in the pharmaceutical industry.
- Formulation Development Expertise: Extensive experience with formulation development of solid oral formulations (tablets, capsules, others) from First-In-Human (FIH) to CTM supplies manufacturing and commercial supplies.
- Hands-on Experience: Hands-on experience with developing suitable formulations for various routes of administration, primarily solid oral formulations.
- QbD-Based Formulation Development: Experience in Quality by Design (QbD)-based formulation development, including statistical design, utilization of scale-independent process parameters, and evaluation of experimental results in designing bioavailable, robust, scale-able formulations.
- CMO Experience: Experience working in-house and managing work at CMOs/CDMOs is preferred.
- Lab-Based Role: This is a lab-based role, and the candidate is expected to be on-site based on company policies.
