Scientist I Drug Substance Technical Operations
About The Position
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky” Mineralys is a fully remote company. Reporting to the Director Technical Operations API, the Scientist I Drug Substance Technical Operations will provide technical and documentation support for Mineralys’s commercial and clinical drug substance manufacturing including process improvements and Corrective and Preventative Actions (CAPA’s).
Requirements
- Knowledge of organic chemistry principles
- Communication Proficiency – oral and written communication are important for this role
- Problem Solving
- Data Analysis
- Proficiency in software for data analysis, presentation, and documentation
- Desire to learn US and EU cGMP requirements, ICH guidelines and best practices relating to drug substance
- Desire to learn about scale up of organic synthesis of small molecule drug substances
- Bachelor’s degree in chemistry or chemical engineering with 3-5 years’ experience in small molecule drug substance manufacturing support
- Master’s degree in chemistry or chemical engineering with 1-3 years’ experience in small molecule drug substance manufacturing support
Responsibilities
- Support of small molecule drug substance manufacturing including batch record review and all aspects of Continued Process Verification (CPV) from data entry to data analysis and reporting.
- Technical support of contract manufacturing including third-party site visits to supervise manufacturing operations, including routine and validation batches.
- Regulatory support such as supporting Annual Product Reports for drug substance.
- Collaborate with Finance and Program Management to ensure budget, schedules and timelines are met as well as Quality Assurance and Regulatory Affairs to assure compliance with applicable GxP and global regulatory requirements.
Benefits
- standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
51-100 employees
