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Mineralys Therapeutics, Inc. · 9 hours ago

Scientist I Drug Substance Technical Operations

US - Greater Philadelphia Region

Full-time

Hybrid

Mid Level

$85K/yr - $105K/yr

3+ years exp

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines for hypertension and related diseases. The Scientist I Drug Substance Technical Operations will provide technical and documentation support for drug substance manufacturing, including process improvements and compliance with regulatory requirements.

BiopharmaBiotechnologyMedicalPharmaceutical

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

Qualification

Organic chemistry principlesData analysisCGMP requirementsICH guidelinesDesire to learnSoftware proficiencyCommunication proficiencyProblem solving

Required

Bachelor's degree in chemistry or chemical engineering with 3-5 years' experience in small molecule drug substance manufacturing support

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

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