Scientist I Drug Substance Technical Operations jobs in United States
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Mineralys Therapeutics, Inc. · 9 hours ago

Scientist I Drug Substance Technical Operations

positionGreater Philadelphia
timeContract
remoteHybrid
seniorityMid Level
money$85K/yr - $105K/yr
date3+ years exp

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. The Scientist I Drug Substance Technical Operations will provide technical and documentation support for commercial and clinical drug substance manufacturing including process improvements and Corrective and Preventative Actions.

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
Master's degree in chemistry or chemical engineering with 1-3 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

Benefits

Medical
Dental
Vision
Time off
401K

Company

Mineralys Therapeutics, Inc.

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At Mineralys Therapeutics we aim to redefine hypertension diagnosis, management and treatment.
dateFounded in 2020
location
Radnor, Pennsylvania, USA
people-size51-200 employees
web-link
http://www.mineralystx.com

Funding

Current Stage
Public Company
Total Funding
$740.5M
Key Investors
TCG Crossover
2025-09-02Post Ipo Equity· $287.5M
2025-03-11Post Ipo Equity· $175M
2024-02-08Post Ipo Equity· $120M

Leadership Team

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David Rodman
Chief Medical Officer
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Erin Gillin
Executive Assistant To Chief Executive Officer
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Recent News

GlobeNewswire
Mineralys Therapeutics Provides Corporate Update and Announces Participation in Upcoming LifeSci Partners Corporate Access Event in January 2026
2026-01-06
GlobeNewswire
Mineralys Therapeutics’ Phase 3 Launch-HTN Trial of Lorundrostat Recognized in Inaugural Journal of the American Medical Association (JAMA) “Research of the Year” Roundup
2025-12-12
MarketScreener
Mineralys Therapeutics' Phase 3 Launch-HTN Trial of Lorundrostat Recognized in Inaugural Journal of the American Medical Association "Research of the Year" Roundup
2025-12-12
Company data provided by crunchbase