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Senior Device Development Manager
3 weeks ago
About Us
We are 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 change the standard of care for patients.
Our lead product candidate, atacicept, is a fully humanized fusion protein self-administered at home as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce galactose-deficient IgA1 (Gd-IgA1) and associated autoantibodies, which together form immune complexes that are fundamental in the pathogenesis of IgA nephropathy (IgAN). We are also considering evaluating the role of atacicept in other immunologic disorders.
In addition to atacicept, we are developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit our website.
Our Values
Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.
Job Description
We are seeking a highly skilled and experienced Principal Engineer to support the device and combination product development activities. This critical role is responsible for the 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, human factors engineering, medical device regulations, and a proven track record of successful product development. The candidate must have exceptional organizational, communication, and people skills, be capable of communicating strategic plans to upper management, summarize data, and effectively manage interactions with stakeholders across functions.
Responsibilities
- Develop and execute a strategic roadmap for biologic/device combination product development, aligning with our overall objectives.
- Lead human factors development activities to ensure usability and patient safety. Primary stakeholder for human factors evaluation of drug delivery combination product development.
- Author and review human factors/usability engineering plans, risk management documentation, study protocols and reports, and supportive design control documentation.
- Collaborate with cross-functional teams, including product development, packaging, manufacturing, clinical development, supply chain, commercial, quality, and regulatory affairs, to ensure successful project delivery.
- Provide technical leadership and expertise in drug delivery technologies, device design, design control, and manufacturing processes.
- Manage and prioritize multiple projects simultaneously, ensuring adherence to timelines and budgets.
- Manage vendor relationships and contracts for outsourced development and manufacturing activities.
- Ensure compliance with all relevant regulatory requirements, throughout the product lifecycle.
- Lead the implementation and management of design control processes and facilitate maintenance of design history file.
- Support packaging development for combination products.
- Demonstrate expertise in prefilled syringe and autoinjector product development.
- Author relevant sections for regulatory submissions.
- Build and maintain strong relationships with key stakeholders, including internal and external partners.
- Support design transfer activities.
Qualifications
- Bachelor's degree in biomedical engineering, mechanical engineering, pharmaceutical sciences, or related field. Advanced degree preferred.
- Over 8 years of experience in drug product device development, with a proven track record of successful product launches. Experience in the pharmaceutical or medical device industry.
- Background in leading human factors formative and summative evaluations including study oversight, authoring of plans, protocols, and reports, anthropometric evaluation, and usability risk assessment.
- Demonstrated knowledge of regulatory requirements and industry best practices.
- Extensive experience with the development and commercialization of prefilled syringes and autoinjectors. Proven experience in implementing and managing design control processes.
- Deep understanding of subcutaneous drug delivery systems, systems engineering, materials, and manufacturing processes. Experience with biological drug products and packaging development a plus.
- In-depth knowledge of current FDA and EU medical device regulations and quality systems.
- Proven experience in vendor management and contract negotiation.
- Experience in cGMP process development, manufacturing controls, and process risk analysis a plus.
- Excellent communication and interpersonal skills in working across the organization.
- Ability to operate in an agile, fast-paced environment. Start-up experience a plus.
- Alignment with our Core Values.
Benefits
We strive to provide employees with total compensation packages that are market competitive. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. We offer various benefits, including medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.
About Vera Therapeutics Inc.
We are an equal-opportunity employer.
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