Leading GxP System Specialist
1 day ago
AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics.
The AmplifyBio ecosystem is comprised of three distinct business units: ADOC (South San Francisco, CA) - Amplify's Discovery, Optimization, and Characterization laboratories: ASET (West Jefferson, OH) - Amplify's Safety, Efficacy, and Toxicology Site; and the most recently opened AMEC (New Albany, OH) - Amplify's Manufacturing Enablement Center.
About AMEC New Albany, OH: AmplifyBio's Manufacturing Enablement Center provides customizable cGMP suites to enable advanced therapy manufacturing in a "hoteling model," traditional contract development and manufacturing (CDMO) or a hybrid model. Partnering with AmplifyBio for manufacturing cell therapy, gene therapy, mRNA, plasmid, or other modality is quite different from a typical CDMO experience. The goal is to provide flexible solutions customized to client needs while bringing full expert partnership. At AmplifyBio drug developers will find an innovation-rich ecosystem designed to advance a diverse range and class of pharmaceutical products across development stages.
We are seeking to hire a Leading GxP System Specialist to join our growing team. The role will be responsible for leading GxP system implementation and providing data integrity and regulatory guidance and oversight throughout the system lifecycle at AmplifyBio. This includes monitoring/maintaining/supporting health, data integrity and regulatory compliance of GxP computerized systems in conformance with all applicable policies and SOPs.
Key Responsibilities:
- Maintain technical SOPs and validation artifacts required to implement and maintain computerized systems
- Lead/manage computerized system validation activities for new implementations or enhancements to existing systems
- Perform and author data integrity and GxP risk assessment to ensure effective requirements are captured and controls are in place to meet global regulatory requirements for GxP systems
Requirements:
- Minimum BA/BS in a life sciences or engineering/computer science or similar scientific discipline (advanced degree preferred)
- A minimum of 5 years' experience and in-depth knowledge of data integrity requirements and GxP computer system validation, and Part 11 requirements in a Pharmaceutical or Biotech environment including understanding software development and supporting validation IT systems in manufacturing and/or laboratories
- In-depth understanding of regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, 58 and 820 and local regulations for assigned areas
Salary Range: $90,000 - $120,000 per year
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