Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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SUMMARY
This company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. The company will continue to focus on advancing therapies that are the first or best of their kind. The Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain the company's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients lives.
The QC Critical Reagents Analyst is responsible for maintaining the Critical Reagents program for commercial products in the global network, including but not limited to reagent preparation, maintaining material inventory, generating technical documentation, and supplying materials to the global testing network. Materials in the Critical Reagents program include qualified reagents, reference standards, custom reagents, analytical cell banks and other important materials that require dedicated oversight. The individual prepares trend graphs and analyses for Critical Reagents to support routine requalification activities, regulatory responses, and investigational activities.
RESPONSIBILITIES
Required Skills:
Desired Skills:
Analyst, QC Critical Reagents
300 Bel Marin Keys Blvd. Novato, CA 94949 US
Posted: 03/12/2025
2025-03-12
2025-04-24
Employment Type:
Contract
Job Category: Scientific
Job Number: 618194
Is job remote?: No
Country: United States
Job Description
SUMMARY
This company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. The company will continue to focus on advancing therapies that are the first or best of their kind. The Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain the company's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients lives.
The QC Critical Reagents Analyst is responsible for maintaining the Critical Reagents program for commercial products in the global network, including but not limited to reagent preparation, maintaining material inventory, generating technical documentation, and supplying materials to the global testing network. Materials in the Critical Reagents program include qualified reagents, reference standards, custom reagents, analytical cell banks and other important materials that require dedicated oversight. The individual prepares trend graphs and analyses for Critical Reagents to support routine requalification activities, regulatory responses, and investigational activities.
RESPONSIBILITIES
- Responsible for critical reagent acquisition, preparation, and aliquoting.
- Coordinates qualification testing with laboratory personnel
- Coordinates and executes critical reagent distributions for the global testing network.
- Utilizes LIMS to document acquisition and preparation of critical reagents, to monitor testing status of critical reagents, and to extract data for trend analyses.
- Generates and maintains critical reagent trending graphs to monitor material stability, assay performance and suitability of qualified ranges, and to support technical documentation.
- Maintains critical reagent inventory and participates in forecasting of critical reagents supply demands.
- Provides input to and/or authors critical reagent technical documentation, including protocols and reports for qualification, requalification, expiry extension, qualified ranges, etc.
- Perform data verification of technical documentation.
- Participate in the generation of new ideas to create efficiencies and improve processes; willingly supports new ideas and process enhancements. Engages in continuous improvement.
- Attend team huddles, department meetings and standard work meetings as required.
- Other duties as assigned.
Required Skills:
- Bachelor’s degree in a related field, or Associate’s degree with additional relevant experience
- 0-3 years of relevant laboratory experience
- Excellent documentation, written and verbal communication skills.
- Computer literacy is required, including proficiency with Microsoft Word and Excel.
- Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or process requirements.
Desired Skills:
- Experience with quality management systems, current Good Manufacturing Practices, and detailed knowledge of QC principles and compliance requirements
- Works with ambiguity and complexity to continuously modify options and solutions.
- Experience with Microsoft PowerPoint, Teams, or Visio is desired.
- Familiar with relevant regulations, including 21CFR, USP, EP, and ICH requirements.
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Discover Exciting Job Opportunities in the Vibrant Novato, California Area! Novato, nestled in Marin County and conveniently located near San Francisco, offers job seekers a perfect blend of suburban charm and urban excitement. With its picturesque surroundings, proximity to the wine country, and access to stunning parks like Stafford Lake Park and the Marin Museum of Contemporary Art, Novato provides a dynamic backdrop for career growth. Enjoy the renowned cuisine at spots like Boca Tavern or trek the beautiful trails at Mount Burdell. Don't miss the Novato Theater Company productions or catch a game at the Novato Community Athletic Fields. Start your career journey in Novato today and experience the magic this bustling town has to offer.
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