Job Description:
This position supports the formulation/product development and manufacturing activities within the Manufacturing Development team of the Technical Operations department.
Responsibilities:
- Report directly to project development leader and maintain weekly updates on activities assigned.
- Function as a designated formulation and process expert for product development activities, both internally and externally. Technically review and provide recommendation in a timely manner (2-3 days) on the following documentation, as applicable:
- Development plans and protocols
- QbD assessment
- Stability protocols
- Associated reports
- Data summarization, graphing and trend analysis
- Function as a designated formulation and process expert for scale-up and optimization activities including but not limited to the following tasks:
- Selection and risk management for CDMO (as assigned by project lead)
- DOE studies, process evaluation, IPC and control strategies
- Oversight of manufacturing, summary of observations and optimization during engineering trials
- Collaborate with client team members for bulk clinical manufacturing and filling
- Projection plan for 2025 supplies
- Monitoring of excipient supplies
- Dispensing record and manufacturing batch record review
- Summarize and maintain batch manufacturing summary
- Collaborate with Quality function and CDMO’s to manage and resolve manufacturing deviations / investigations
- Assist in the selection and management of the radiolabeling ADME work stream of the programs, namely
- Vendor selection
- Work plan
- DP development
- Non-gmp manufacturing
- GMP manufacturing
- Shipment logistics
- DP development studies and testing to support API changes
- Polymorph form switch
- API site changes
- API manufacturer switch
- Literature searches (i.e. pediatric application)
- Maintain product documentation and data files in appropriate platforms
- Support regulatory filing needs
- Collaborate with the Supply Chain team to manage shipment of R&D, GLP and GMP supplies/components
- Support selection and finalization of the packaging configuration for the drug products
Qualifications:
- 10+ (or 8+) years of pharmaceutical formulation development experience with a BS (or MS/PhD) in a scientifically relevant field (Chemical Engineering, Pharmaceutical Engineering, Pharmaceutical Sciences, etc.)
- Technical Subject Matter Expert (SME) in development of pharmaceutical dosage forms (oral solids/liquids and other dosage forms)
- Experience in process development, scale-up and optimization related to gmp manufacturing and packaging of drug products
- High ethical & quality standards and lives them through actions and communication
- Strong computer, organizational, and analytical skills required
- Strong verbal and written communication skills with the ability to communicate to colleagues, business partners, stakeholders across varied styles and cultures
Remote: Formulation Consultant (236941)
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