Principal Consultant

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🔥 17 minutes ago

🏈 Alabama, California, +3 more states – Remote

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⏰ Full Time

🔴 Lead

💼 Consultant

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ToxStrategies, a BlueRidge Life Sciences Company

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2008

🔬 Science

💊 Pharmaceuticals

🤝 B2B

💰 Venture Round - ToxStrategies on 2023-01

Science • Pharmaceuticals • B2B

ToxStrategies is a multidisciplinary scientific consulting firm and BlueRidge Life Sciences company that provides toxicology, environmental, and regulatory science services to industry, government, and legal clients. The firm offers expertise in risk assessment, exposure assessment, computational toxicology, bioavailability, PFAS, micro- and nanoplastics, food and pharmaceutical safety, medical devices, NAMs, epidemiology, and regulatory compliance (e. g. , TSCA, FSMA, Proposition 65). ToxStrategies supports product stewardship, litigation support, and evidence-based toxicology across consumer products, chemicals, and biopharmaceutical contexts.

📋 Description

• Participate in the project management and technical work of combination product development and support clients in bringing life-saving therapies to patients. • Lead technical discussion for internal and client teams as a technical subject matter expert on the development of drug delivery systems • Align program execution with industry standards, external regulatory requirements and site quality management systems • Develop design control deliverables to document compliance to medical device development processes • Prepare detailed, concise reports on completed studies that summarize the test results and their conformance to defined acceptance criteria • Establish and maintain project timelines and deliverables and maintain accountability for project budgets and program execution.

🎯 Requirements

• 10+ years as Principal or Sr. Principal systems engineer, technical lead, or equivalent experience in the development of combination products and/or medical devices. • BS in Engineering, Biology, Physics or related Scientific discipline • Master’s degree in Engineering, Biology, Physics or related Scientific discipline is desired. • Technical management of programs in both direct or matrix reporting organizations, coordinating and leading multiple team members through the execution of program deliverables. • Experience with the total lifecycle management of medical device programs, with preferred experience in the clinical and commercial development of drug delivery systems (combination products) • Direct experience developing design history file documentation in quality management systems, including Design and Development Plans User needs Requirements Risk management Verification Validation Design Transfer • Experienced in leading technical discussion for internal and client teams as a technical subject matter expert on the development of drug delivery systems • Preferred that candidate has pharmaceutical-related medical device experience on combination products and/or drug delivery systems • Understanding of DHF elements, and their integration through the medical device development process. • Thorough understanding of medical device processes: Design Controls (21 CFR 820.30) ISO13485 ISO14971 • Preferred SOP Writing and Review • Experience with, as well as experience and flexibility to work under a number of different quality management systems • Preferred, experience supporting regulatory teams in the authoring of regulatory submissions • Highly preferred, Experience with project management • Experience with one or more Autoinjectors, Pre-filled syringe, or on-body delivery systems is a plus

🏖️ Benefits

• Health insurance • Professional development • Flexible work arrangements