Job Details

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: 6 Months

Rate: Up to 35 / hr

Location: San Diego County, California

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.