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Astrix

Astrix

via LinkedIn

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Process Improvement Scientist

San Diego, CA
contractor
Posted 9/4/2025
Verified Source
Key Skills:
Statistical analysis
Manufacturing data analysis
KPI generation and tracking
Data visualization
GMP environment experience
Analytical chemistry techniques (HPLC, LC-MS, GC)
FDA regulations compliance
Reporting tools (Hyperion/Brio)

Compensation

Salary Range

$62K - 73K a year

Responsibilities

Collect, analyze, and visualize manufacturing production data to improve processes and efficiency while ensuring regulatory compliance.

Requirements

Requires a BA/BS in a related field, 6+ years GMP manufacturing experience, proficiency in statistical analysis and reporting tools, and knowledge of analytical chemistry and FDA regulations.

Full Description

Our client is currently the leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. The company, which has over 50 years of experience and expertise, provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Contract (2 Months) Up to 35/hr San Diego County, California (LOCAL CANDIATES ONLY) Process Improvement / Manufacturing Data Analyzing Job Description: • Responsible for the collection, statistical analysis, and visualization of production data to enhance manufacturing processes, efficiency, and robustness. • Analyze data from both ongoing and historical manufacturing activities, providing actionable insights and recommendations to the management team. • Identify areas for improvement in production processes and recommend necessary actions or controls to enhance performance. • Generate and track Key Performance Indicators (KPIs) to help focus strategic and operational improvements. • Work as an individual contributor within the production department, coordinating with other teams and sites as necessary. • Communicate findings effectively to management using data visualizations, reports, and presentations. • Collaborate with cross-functional teams, ensuring adherence to regulatory requirements and company standards. Qualifications: Required: • BA/BS in Chemistry, Industrial Hygiene, Pharmacology, or a related field. • Minimum of 6 years of experience in a GMP (Good Manufacturing Practice) environment. • Proficient in statistical analysis applied to pharmaceutical manufacturing. • Exposure to reporting tools such as Hyperion/Brio or other advanced statistical software. • Strong understanding of analytical chemistry techniques such as HPLC, LC-MS, and GC. • Knowledge of FDA regulations and compliance standards in a manufacturing setting. • Exceptional written and oral communication skills, with the ability to present complex data clearly. Preferred: • Master’s Degree in a related field. • Experience with project management and presenting findings to stakeholders. • Knowledge of regulatory and ISO standards in manufacturing.

This job posting was last updated on 9/7/2025

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