Senior Manager, Drug Device Combination Product Development
vor 2 Wochen
Title: Senior Manager, Drug Device Combination Product DevelopmentLocation: Brisbane, CAAbout Us:Vera Therapeutics (Nasdaq: VERA) is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of immunologic diseases to change the standard of care for patients.Position Summary:We are seeking a highly skilled and experienced Sr. Manager, Drug Device Combination Product Development to lead the device and combination product development activities at Vera. This role is responsible for the overall strategy, development, and execution of biologic/device combination product projects from concept to commercialization. The ideal candidate will possess a deep understanding of drug delivery systems, medical device regulations, and a proven track record of successful product development.Responsibilities:Develop and execute a strategic roadmap for biologic/device combination product development, aligning with the company's overall objectives.Collaborate with cross-functional teams to ensure successful project delivery.Provide technical leadership and expertise in drug delivery technologies and device design.Manage and prioritize multiple projects simultaneously, ensuring adherence to timelines and budgets.Ensure compliance with all relevant regulatory requirements, including FDA and EU regulations.Lead the implementation and management of design control processes.Lead human factors development activities to ensure usability and patient safety.Author relevant sections for regulatory submissions.Build and maintain strong relationships with key stakeholders.Qualifications:Bachelor's degree in biomedical engineering, mechanical engineering, pharmaceutical sciences, or a related field. Advanced degree preferred.6+ years of experience in drug product device development, with a proven track record of successful product launches.Extensive experience with the development and commercialization of prefilled syringes and autoinjectors.Deep understanding of subcutaneous drug delivery systems, materials, and manufacturing processes.In-depth knowledge of current FDA and EU medical device regulations.Excellent communication and interpersonal skills.Ability to operate in alignment with Vera's Core Values.Vera Therapeutics Inc. is an equal-opportunity employer.
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Brisbane, Österreich Vera Therapeutics, Inc VollzeitTitle: Senior Manager, Drug Device Combination Product Development Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA) is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of immunologic diseases to change the standard of care for...
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vor 1 Monat
Brisbane, Österreich Vera Therapeutics, Inc VollzeitTitle: Associate Director, Quality Assurance – Medical Device/Combination ProductLocation: Brisbane, California About Us:Vera Therapeutics (Nasdaq: VERA) is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of immunologic diseases in order to...
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vor 1 Monat
Brisbane, Österreich Vera Therapeutics, Inc VollzeitTitle: Associate Director, Quality Assurance – Medical Device/Combination Product Location: Brisbane, California About Us: Vera Therapeutics (Nasdaq: VERA) is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of immunologic diseases in order to...
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