Principal Engineer
Aimmune Therapeutics is looking for a talented senior/principal engineer to support the early-stage biologics programs (i.e. monoclonal antibodies, enzymes, proteins). The successful candidate will focus on parenteral drug products utilizing drug/device delivery systems. This role will serve as the subject matter expert in the areas of combination product development, device design controls, design verification testing and human factors. Collaboration across various functions within Aimmune and CDMO sites is essential; thus, the candidate must have the ability to influence others with strong oral and written communication skills. The candidate will be expected to share opinions, ask and answer challenging questions, and demonstrate collaborative attitude, all in the context of excellent science, as Aimmune continues to create innovative new medicines.
Responsibilities:
Lead the development of drug/device combination product from concept to commercialization Oversee the development and execution of technical evaluation plans and ensure compliance with design controls and other global standards including 21 CFR Part 820 Medical Device Quality Systems Regulation and 21 CFR Part 4 Regulation of Combination Products. Collaborate with QA to author, review, and approve technical reports and design control documentation Manage the GMP readiness and manufacturing at CDMO sites, such as technical transfer, batch record and documentation review, and quality management systems (i.e. deviations, CAPAs, change controls) Design studies for development, troubleshooting, and characterization. Use statistical tools to analyze product and process attributes Serve as a subject matter expert for combination products and device delivery systems, author and/or review technical reports and relevant sections of CMC documentation in support of regulatory submissions and amendments as well as meetings with regulatory authorities Collaborate and work with analytical development/QC and QA teams to support manufacture, lot release, and stability evaluation in compliance with cGMPs Other responsibilities that may be assigned from time to time to progress Aimmune's pipeline or commercial programs Experience, Special Skills, Knowledge:
BSc (or higher) in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, or a related scientific field A minimum of 8 years of directly related biopharmaceutical industry experience with at least 3 years in drug/device combination product development Experience with the development and commercialization of combination products with or without using external CDMOs Demonstrated knowledge of medical device development methodologies such as design controls, risk management (product FMEA and process FMEA), verification testing, design transfer and human factors Working knowledge of FDA (21 CFR Part 820, 21 CFR Part 4), EMA (ISO 13485), and other relevant global standards Strong verbal and written communication skills, with the ability to communicate effectively with others both within and external to the organization Effective decision making, demonstrating good judgment and constructive escalation Proactive in consistently anticipating and proposing solutions to potential problems before they arise A team player with a hands-on approach, able to quickly establish credibility, build rapport and trust and influence and maintain effective working relationships internally and externally.
Salary Range:
$80K -- $100K
Minimum Qualification
Physical SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Lead the development of drug/device combination product from concept to commercialization Oversee the development and execution of technical evaluation plans and ensure compliance with design controls and other global standards including 21 CFR Part 820 Medical Device Quality Systems Regulation and 21 CFR Part 4 Regulation of Combination Products. Collaborate with QA to author, review, and approve technical reports and design control documentation Manage the GMP readiness and manufacturing at CDMO sites, such as technical transfer, batch record and documentation review, and quality management systems (i.e. deviations, CAPAs, change controls) Design studies for development, troubleshooting, and characterization. Use statistical tools to analyze product and process attributes Serve as a subject matter expert for combination products and device delivery systems, author and/or review technical reports and relevant sections of CMC documentation in support of regulatory submissions and amendments as well as meetings with regulatory authorities Collaborate and work with analytical development/QC and QA teams to support manufacture, lot release, and stability evaluation in compliance with cGMPs Other responsibilities that may be assigned from time to time to progress Aimmune's pipeline or commercial programs Experience, Special Skills, Knowledge:
BSc (or higher) in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, or a related scientific field A minimum of 8 years of directly related biopharmaceutical industry experience with at least 3 years in drug/device combination product development Experience with the development and commercialization of combination products with or without using external CDMOs Demonstrated knowledge of medical device development methodologies such as design controls, risk management (product FMEA and process FMEA), verification testing, design transfer and human factors Working knowledge of FDA (21 CFR Part 820, 21 CFR Part 4), EMA (ISO 13485), and other relevant global standards Strong verbal and written communication skills, with the ability to communicate effectively with others both within and external to the organization Effective decision making, demonstrating good judgment and constructive escalation Proactive in consistently anticipating and proposing solutions to potential problems before they arise A team player with a hands-on approach, able to quickly establish credibility, build rapport and trust and influence and maintain effective working relationships internally and externally.
Salary Range:
$80K -- $100K
Minimum Qualification
Physical SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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